supply of medical devices (used in central sterilization) from the package list, in quantities resulting from the current needs of the Ordering Party, transport of the Contractor or at his expense. Tender No 1 for the offer (assortment form 0 price) 3. If the Contractor is established or domiciled outside the Republic of Poland:

3.1 instead of the documents referred to in paragraph 2 (2.2), submits a document or documents issued in the country where the contractor is established or domiciled confirming that no liquidation has been opened, no bankruptcy has been declared, his assets are not managed by the liquidator or court, has not concluded an arrangement with creditors, its business activities are not suspended or in any other situation arising from a similar procedure provided for in the provisions of the place of initiation of that procedure - issued no earlier than 3 months prior to its submission (Chapter IX.pkt.3);

Biological indicator set for control of steam sterilization at 121 st C and 134 st C -description zal no 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Sub-infective packaging -description of zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Integrated indicators of batch control - description of zany no 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Biological indicator for control of ethylene oxide sterilization -description of zal No 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Non-woven for sterilization 120 x 120cm -description zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

.Indicator for the control of the thermal disinfection process at 90st.C/5min -description of the field no. 1 to the offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Emulative sterilization test type/class 6 (TST), (T time, S — steam, T — temperature) -description zal No 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Quick test for detecting residues of protein contaminants after the process of washing and disinfection of medical tools and equipment, -description of zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Test of welding control in the form of a test sheet with a black test field, -description of zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

ULTRA-Polyolefin-foil sterilization sleeve, polyolefin weight 93g\ m2 intended for sterilization, -description zł No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Double-sided brush for washing tools with handle -description zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Test to control the effectiveness of mechanical washing in washers-disinfectors. -description of the range no. 1 to the offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Brush for cleaning working ducts bottom 60-70 cm - description in zł No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Double adhesive three-row labels for documentation system with vapor sterilization indicator - description in zal no. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Cover bags, dust-tight precillation - description in zń No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Non-woven purgatory for the removal of raids and rust - description in zal no. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Ethylene oxide cartridges for sterilizer STERIL — VAC 5 XL; 4-100, - description in box no. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Indicator to control the thermal disinfection process at 90st.C/5min. -description of the range no. 1 to the offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

.Protectors for corners of sterilization trays -description of zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

.Multi-parameter test for control for steam sterilization class 4 -description of zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Paper sleeve — foil disposable medical packaging for vapor sterilization, ethylene oxide with sterilization process indicators. -description of the range no. 1 to the offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Single use package type Bovie Dick -description zych No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Indicator tape, self-adhesive to water vapor, -description of zło No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).

Chemical indicator for control for steam sterilization class 5 -description zal No. 1 to offer

Price 60%

Delivery date “T” — 40%

12. Evidence measures in question:

The Contracting Authority shall request the following measures of evidence for confirmation that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) Samples (quantities of samples were periodified in Annex 1 to the tender (assortment — price)) to verify the proposed range with the description of the item. The samples shall correspond to the parameters specified in the detailed description in the assortment and price form. Samples are not refundable. Address of the delivery of the required samples: Dolnośląskie Center for Płuc Diseases in Wrocław, Grabiszyńska street 105, 53-439 Wrocław. Office room No. 4, high ground floor (taking samples from pn to pt in hours from 7.45 to 13.30) with description on the package:,, samples for proceedings no BZP 3810.63.2021.TP to pack/ow... (for the package with samples please attach a list of samples on what package and how many pieces).

2) Important and current at the opening day of tenders supporting the authorisation of marketing on the territory of Poland in accordance with the Act of 20 May 2010 on medical devices:

a. Declaration/e of conformity,

b. Certificate of conformity (issued by a notified body, if required),

c. Confirmation that the medical device offered has been notified or entered in the register of medical devices and entities responsible for placing them on the market or notified of the device under Article 58 of the Medical Devices Act (name of the device notified/entered in the register correspond to the trade name /catalogue of the product offered).

If (according to the contents of Article 13 of the Act) the manufacturer is not domiciled or established in the State

the Member and has not appointed an authorised representative, or if the product is not placed on the market under the responsibility of the manufacturer or an authorised representative, it shall inform the Contracting Authority thereof by attaching an appropriate statement to the offer. If a medical device is not subject to entry in the Register of Medical Devices and the entities responsible for placing on the market and use thereof, a statement must be accompanied with reasons why the alert is not subject to the entry.

attention

Each document should be described what item in Annex 1 to the SWZ applies.

The corresponding manufacturer catalogues (containing catalogue numbers of the products offered), folders or source materials of the manufacturer/manufacturer's statements in a clear and clear manner confirming the fulfilment of the technical and utility parameters described by the Ordering Party in Annex 1 to the Offer. Failure to confirm the required parameters will be considered as failure to comply with the equipment offered and will result in the rejection of the offer unless the conditions set out in Article 128.In the case of drawing up the above documents in a foreign language, the document (s) should be attached to the tender together with a translation into Polish. The Contracting Authority reserves the right to verify the reliability of the parameters provided by the Contractor in all available sources- applies to package number 1-24

• Where the subject of the contract described in the SWZ is not classified as a medical device and, in accordance with the European Directives and the Medical Devices Act, is not covered by declarations of conformity and is not subject to any alert, the contracting officer shall require an appropriate declaration.

12.1. The Contractor shall submit the evidence in question together with the offer (Art.107 (1) pzp).

12.2 If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set (Art.107 (2) pzp).