Poland - Medical devices

Description

The contract includes: 1 - Infusion fluid heater - 6 pcs. (warm nebulization) 2 - Patient warmer with duvets - 1 pcs. A detailed description of the subject matter of the contract can be found in Annex 1 to Part 1. The offered subject matter of the contract must meet the requirements set out in: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, items 876 and 1918). Regulation of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416). Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211). Regulation of the Minister of Health of 17.2.2016 on the manner of filing notifications and notifications concerning products (Journal of Laws of 2016, item 210). Regulation of the Minister of Health of 22.9.2010 on the model of the CE mark (Journal of Laws 2010, No. 186, item 1252). Ordinance of the Minister of Development and Finance of 21.12.2016 on essential requirements for limiting the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7). Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011). Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Art. 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of the offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Ordering Party along with the delivery of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Additional requirements: a) Start-up and training at the Ordering Party's premises. The training may be conducted on the day of delivery or at any other time agreed with the Purchaser. The training is understood as instruction in basic operation and maintenance of medical equipment. Warranty period: min. 24 months. The contract includes: Continuous blood purification device - 1 pcs. A detailed description of the subject matter of the contract can be found in Annex 1 to Part 2. The offered subject matter of the contract must meet the requirements set out in: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, items 876 and 1918). Regulation of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416). Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211). Regulation of the Minister of Health of 17.2.2016 on the manner of filing notifications and notifications concerning products (Journal of Laws of 2016, item 210). Regulation of the Minister of Health of 22.9.2010 on the model of the CE mark (Journal of Laws 2010, No. 186, item 1252). Ordinance of the Minister of Development and Finance of 21.12.2016 on essential requirements for limiting the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7). Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011). Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Art. 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of the offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Ordering Party along with the delivery of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. (a) Required availability of spare parts for a minimum period of time. 10 years after the expiry of the warranty period. Warranty period: min. 24 months. The contract includes: 1 - Heating device for liquids - 1 pcs. 2 - Self-pressing bag of ambu type - 6 pcs. 3 - Resuscitation bag with ampulator - 1 pcs. 4 - Roller conveyor belt - 2 pcs. 5 - Cardiological stethoscope - 7 pcs. A detailed description of the subject matter of the contract can be found in Annex 1 to Part 3. The offered subject matter of the contract must meet the requirements set out in: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, items 876 and 1918). Regulation of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416). Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211). Regulation of the Minister of Health of 17.2.2016 on the manner of filing notifications and notifications concerning products (Journal of Laws of 2016, item 210). Regulation of the Minister of Health of 22.9.2010 on the model of the CE mark (Journal of Laws 2010, No. 186, item 1252). Ordinance of the Minister of Development and Finance of 21.12.2016 on essential requirements for limiting the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7). Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011). Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Art. 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of the offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Ordering Party along with the delivery of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Warranty period: min. 24 months. The contract includes: Laminar chamber single station - 1 pcs. A detailed description of the subject matter of the contract can be found in Annex 1 to Part 4. The offered subject matter of the contract must meet the requirements set out in: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, items 876 and 1918). Regulation of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416). Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211). Regulation of the Minister of Health of 17.2.2016 on the manner of filing notifications and notifications concerning products (Journal of Laws of 2016, item 210). Regulation of the Minister of Health of 22.9.2010 on the model of the CE mark (Journal of Laws 2010, No. 186, item 1252). Ordinance of the Minister of Development and Finance of 21.12.2016 on essential requirements for limiting the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7). Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011). Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Art. 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of the offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Ordering Party along with the delivery of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Additional requirements: a) Start-up and training at the Ordering Party's premises. The training may be conducted on the day of delivery or at any other time agreed with the Purchaser. The training is understood as instruction in basic operation and maintenance of medical equipment. b) Service response time up to 72 hours from the date and time of notification (e-mail, fax or telephone - immediately confirmed by e-mail). The reaction time is understood as the beginning of the repair of the device at the Customer's premises. The contract includes: 1 - Bactericidal flow lamp - 1 set 2 - Electric mobile mammal on a trolley with battery - 3 pcs. A detailed description of the subject matter of the contract can be found in Annex 1 to Part 5. The offered subject matter of the contract must meet the requirements set out in: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, items 876 and 1918). Regulation of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416). Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211). Regulation of the Minister of Health of 17.2.2016 on the manner of filing notifications and notifications concerning products (Journal of Laws of 2016, item 210). Regulation of the Minister of Health of 22.9.2010 on the model of the CE mark (Journal of Laws 2010, No. 186, item 1252). Ordinance of the Minister of Development and Finance of 21.12.2016 on essential requirements for limiting the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7). Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011). Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Art. 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of the offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Ordering Party along with the delivery of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Additional requirements: a) Start-up and training at the Ordering Party's premises. The training may be conducted on the day of delivery or at any other time agreed with the Purchaser. The training is understood as instruction in basic operation and maintenance of medical equipment. Warranty period: min. 24 months. The contract includes: 1 - Swimming pool and duck washer - 1 pcs. 2 - Room disinfection fogger - 1 pcs. A detailed description of the subject matter of the contract can be found in Annex 1 to Part 6. The offered subject matter of the contract must meet the requirements specified in: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, items 876 and 1918). Regulation of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416). Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211). Regulation of the Minister of Health of 17.2.2016 on the manner of filing notifications and notifications concerning products (Journal of Laws of 2016, item 210). Regulation of the Minister of Health of 22.9.2010 on the model of the CE mark (Journal of Laws 2010, No. 186, item 1252). Ordinance of the Minister of Development and Finance of 21.12.2016 on essential requirements for limiting the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7). Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011). Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Art. 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of the offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Ordering Party along with the delivery of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Additional requirements: a) Start-up and training at the Ordering Party's premises. The training may be conducted on the day of delivery or at any other time agreed with the Purchaser. The training is understood as instruction in basic operation and maintenance of medical equipment. For the purpose of this report, please refer to the following (a) Availability of consumables and spare parts for at least one year. b) Periodic inspections are required during the warranty period in accordance with the recommended operating conditions of the device at no additional cost. Entries in the technical passport with the date of release to service shall be required. Maintenance intervals must guarantee the continuous operation of the unit. Warranty period: min. 24 months.

Opportunity closing date

21 January 2019

Value of contract

£0-100k