Miscellaneous medical devices and products

Contract Value:: -
Notice Type:: Contract Notice

Published Date:: 09 December 2022
Closing Date:: 09 January 2023

Location(s):: PL POLSKA (PL Poland/POLSKA)

Description:

Supply of materials for sterilization

1. The subject of the contract is the supply of sterilization materials.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

4. The expiry date of the products may not be shorter than 12 months from the moment of its delivery to the Ordering Party's headquarters.

5. The item of the order will be delivered at the cost, risk and transport of the Contractor.

Sterilization packaging - blue sterilization non-woven fabric, tapes for closing packages

1. The subject of the contract is the supply of materials for sterilization.- Part No. 1: Sterilization packaging - blue sterilization non-woven fabric, tapes for closing packages.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

4. The offered subject of the contract must be compliant and admitted to trading and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices, European Union Directive 93/42 / EEC of 14 June

1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

5. The offered products must be medical devices within the meaning of the Act on Medical Devices of 7 April 2022. This requirement concerns: Part No. 1 – items 1, 2, 3

6. The Ordering Party requires that the generic name of the product, the trade name (if the product has one), the manufacturer, the dimensions of the product, the series, the expiry date, the CE symbol and the catalogue code, the UDI code (if applicable, in accordance with EU Regulation 2017/745) appear on each unit packaging and packaging. Each sterile product must have a wrapping (direct) packaging.

7. In the case of offering products in packaging other than those described in the assortment and price form, the Ordering Party allows the conversion of the size of packages with rounding up to full packages. Packages may not be larger than those specified in the price form, if the maximum size is given.

8. All information about products placed on labels or packaging must be prepared in Polish or in the form of symbols permitted by applicable law

9. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

10. The expiry date of the products may not be shorter than 12 months from the moment of its delivery to the Ordering Party's registered office.

11. The subject of the contract will be delivered at the Contractor's cost, risk and transport.

Consumables and biological and chemical indicators for ethylene oxide sterilization.

1. The subject of the contract is the supply of sterilization materials.- Part No. 10: Consumables and biological and chemical indicators for ethylene oxide sterilization.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

5. The Ordering Party requires that the generic name of the product, the trade name (if the product has it), the manufacturer, the dimensions of the product, the series, the expiry date, the CE symbol and the catalogue code, the UDI code (if applicable, in accordance with EU Regulation 2017/745) appear on each unit packaging and packaging. Each sterile product must have a wrapping (direct) packaging.

6. In the case of offering products in packaging other than those described in the assortment and price form, the Ordering Party allows the conversion of the size of packages with rounding up to full packages. Packages may not be larger than those specified in the price form, if the maximum size is given.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Batch control tests for steam sterilization.

1. The subject of the contract is the supply of sterilization materials.- Part No. 11: Tests for the control of steam sterilization charge.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Tests for the control of machine washing processes.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 12: Tests for the control of machine washing processes.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Tests for the control of thermal disinfection.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 13: Tests for the control of thermal disinfection.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Tool tray plates.

1. The subject of the contract is the supply of sterilization materials.- Part No. 14: Plates for tool trays.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Seals, labels, filters for sterilization containers.

1. The subject of the contract is the supply of sterilization materials.- Part No. 15: Seals, labels, filters for sterilization containers.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Sterilization accessories.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 16: Sterilization accessories.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Cleaners for duct tools.

1. The subject of the contract is the supply of sterilization materials.- Part No. 17: Cleaners for duct instruments.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Containers for the transport of contaminated medical devices.

1. The subject of the contract is the supply of sterilization materials.- Part No 18: Containers for the transport of contaminated medical devices.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Containers, baskets for washing microsurgical instruments, Kirschner wires and small elements of instruments

1. The subject of the contract is the supply of sterilization materials.- Part No. 19: Containers, baskets for washing microsurgical instruments, Kirschner wires and small elements of instruments

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Sterilization packaging - a combination of nonwovens

1. The subject of the contract is the supply of materials for sterilization.- Part No. 2: Sterilization packaging - combination of nonwovens

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

5. The offered products must be medical devices within the meaning of the Act on Medical Devices of 7 April 2022. This requirement concerns: Part No. 2 – items 1, 2, 3

8. All information about products placed on labels or packaging must be prepared in Polish or in the form of symbols permitted by applicable law

9. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

10. The expiry date of the products may not be shorter than 12 months from the moment of its delivery to the Ordering Party's registered office.

11. The subject of the contract will be delivered at the Contractor's cost, risk and transport.

Oil for the care of orthopedic drives type Acculan, PTFE filters.

1. The subject of the contract is the supply of sterilization materials.- Part No. 20: Oil for the care of orthopedic drives type Acculan, PTFE filters.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Silicone bands and covers for surgical instruments.

1. The subject of the contract is the supply of sterilization materials.- Part No. 21: Silicone bands and casings for surgical instruments.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Towels for surgical instruments.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 22: Towels for surgical instruments.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Sterilization packaging - paper-foil sleeves.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 3: Sterilization packaging - paper-foil sleeves..

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

5. The offered products must be medical devices within the meaning of the Act on Medical Devices of 7 April 2022. This requirement applies to: Part No. 3 – items 1, 2, 3, 4, 5

8. All information about products placed on labels or packaging must be prepared in Polish or in the form of symbols permitted by applicable law

9. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

10. The expiry date of the products may not be shorter than 12 months from the moment of its delivery to the Ordering Party's registered office.

11. The subject of the contract will be delivered at the Contractor's cost, risk and transport.

Sterilization packaging - paper-foil bags.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 4: Sterilization packaging - paper-foil bags.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

5. The offered products must be medical devices within the meaning of the Act on Medical Devices of 7 April 2022. This requirement applies to: Part No. 4 – items 1, 2, 3, 4, 5, 6, 7,8, 9

8. All information about products placed on labels or packaging must be prepared in Polish or in the form of symbols permitted by applicable law

9. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

10. The expiry date of the products may not be shorter than 12 months from the moment of its delivery to the Ordering Party's registered office.

11. The subject of the contract will be delivered at the Contractor's cost, risk and transport.

Sterilization packaging - Polyolefin Ultra sleeve.

1. The subject of the contract is the supply of sterilization materials.- Part No. 5: Sterilization packaging - Polyolefin Ultra sleeve.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

5. The offered products must be medical devices within the meaning of the Act on Medical Devices of 7 April 2022. This requirement applies to: Part No. 5 – items 1, 2, 3,

8. All information about products placed on labels or packaging must be prepared in Polish or in the form of symbols permitted by applicable law

9. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

10. The expiry date of the products may not be shorter than 12 months from the moment of its delivery to the Ordering Party's registered office.

11. The subject of the contract will be delivered at the Contractor's cost, risk and transport.

Weld correctness tests.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 6: Weld correctness tests.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Documentation of decontamination processes.

1. The subject of the contract is the supply of materials for sterilization.- Part No. 7: Documentation of decontamination processes.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Biological indicators for the control of steam sterilization.

1. The subject of the contract is the supply of sterilization materials.- Part No. 8: Biological indicators for the control of sterilization by steam.

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

Chemical indicators for the control of sterilization by steam

1. The subject of the contract is the supply of sterilization materials.- Part No. 9: Chemical indicators for the control of sterilization by steam

2. The subject of the contract for individual parts of the contract is described in detail in Appendix No. 2 to the SWZ.

3. In Appendix 2 to the SC, the Contracting Authority requires the Contractor to provide the trade name of the product and the manufacturer of the subject of the contract offered by the Contractor.

7. All information about products placed on labels or packaging must be drawn up in Polish or in the form of symbols permitted by applicable law

8. The Ordering Party requires that orders be executed in accordance with the requirements provided for medical devices (applies to medical devices).

9. The expiry date of the products may not be shorter than 12 months from the moment of delivery to the Ordering Party's registered office.

10. The subject of the contract shall be delivered at the expense, risk and transport of the Contractor.

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The Buyer:: Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

CPV Code(s):: 33190000 - Miscellaneous medical devices and products