Wipes for Surface Cleaning & Disinfection

Description

This notice is issued to inform potential suppliers of a procurement that NHS Supply Chain intends to commence during the subsequent 12 months for the provision of Wipes and accessories for the purpose of surface cleaning and disinfection. Products include but are not limited to Indicator Products, Combined Detergent & Disinfection, Detergent, Disinfection, Sporicidal and Sterile Alcohol wipes. Precise quantities are unknown. Criteria applicable across all product lines: Medical Devices Directive 93/42/EEC (as amended) All products must have their CE marking evident on the product and/or packaging. Or Medical Devices Regulation 2017/745 (as amended) All products must have their CE marking evident on the product and/or packaging. CLP Regulation (EC) 1272/2008 REACH Regulation (EC) No 1907/2006 EU Biocides Regulation 528/2012 (EU BPR) It is anticipated that initial expenditure will be in the region of £31,273,365 (Cost Inc. VAT) in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. The estimated value over the total Framework Agreement term (3+1-year term) is anticipated to be approximately £149,891,653 (Cost Inc. VAT) The Framework Agreement between NHS Supply Chain and successful suppliers will reserve the right to purchase the same or similar supplies and/or services from suppliers not appointed to the Framework Agreement at its sole discretion. NHS Supply Chain intends to enter into arrangements under which it will be entitled to purchase supplies and/or services which it will make available for purchase by 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body and/or 4) any private sector entity active in the UK healthcare sector. Only NHS Supply Chain can order from the Framework Agreement and enter into contracts under it. Lot 1: Indicator Products This Lot is for adhesive notes or tape used to indicate that a device has been cleaned. For avoidance of doubt this Lot does not include chemical indicators. Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £523,597 Inc. VAT in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Lot 2: Combined 2 in 1 Wipes This Lot is for Wipes that are impregnated with a detergent and disinfectant liquid for the cleaning and disinfection of surfaces and/or non-invasive medical devices. All products must be suitable for use in the Healthcare and Healthcare related environment, typically within the NHS sector. All products on this Lot must meet current standards and Regulations: Regulation (EC) No 648/2004 on detergents: If applicable to combination wipes with both detergent & disinfection action BS EN 16615:2015 Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and Yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test). Test method and requirements (phase 2, step 2) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Testing must be conducted in “dirty” conditions as prescribed in the standard BS EN 16615:2015 BS EN 14476:2013+A2:2019 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Minimum spectrum of test organisms - Virucidal activity against enveloped viruses and Norovirus. • Testing must be conducted in “dirty” conditions as prescribed in the standard BS EN 14476:2013+A2:2019. • Testing must be conducted with liquid extracted from the wipe. And where applicable and available the following: BS EN 16777:2018 Chemical disinfectants and antiseptics. Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase 2/step 2) BS EN 14885:2018 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics Wipes must be tested at laboratories that are UKAS or independent Equivalent accredited with BS EN 17025:2017. NHS Supply Chain may stipulate testing of Applicant’s Goods at the Applicant’s expense or request further information from the Applicant to ensure the Goods comply with the Specification at any time during the Tender or post tender. In the event that the product(s) do not meet the Specification, NHS Supply Chain will reserve the right to exclude the Goods from the Framework Agreement and/or the tender process (as the case may be). Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £21,278,779 Inc. VAT in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Lot 3: Detergent Wipes This Lot is for Wipes that are impregnated with a detergent solution, used for cleaning and damp dusting without additional antimicrobial agents. All products must be suitable for use in the Healthcare and Healthcare related environment, typically within the NHS sector. All products must meet current standards and Regulations: Detergents Regulation (EC) No.684/2004 NHS Supply Chain may stipulate testing of Applicant’s Goods at the Applicant’s expense or request further information from the Applicant to ensure the Goods comply with the Specification at any time during the Tender or post tender. In the event that the product(s) do not meet the Specification, NHS Supply Chain will reserve the right to exclude the Goods from the Framework Agreement and/or the tender process (as the case may be) Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of£1,181,111 Inc. VAT in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Lot 4: Sporicidal Wipes This Lot is for Wipes that are impregnated with active ingredients that have sporicidal properties, for example, peracetic acid, hydrogen peroxide or chlorine both wet and dry. All products must be suitable for use in the Healthcare and Healthcare related environment, typically within the NHS sector. All products must meet current standards and Regulations: BS EN 17126:2018 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area. Test method and requirements (phase 2, step 1) Amendment to the standard requirements: • The maximum contact time for a suspension test must be 5 minutes or shorter • Must use Clostridium difficile spores as one of the test organisms • Testing must be conducted in “dirty” conditions as prescribed in the standard. • Testing must be conducted with liquid extracted from the wipe And where applicable and available the following: BS EN 14476:2013+A2:2019 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Minimum spectrum of test organisms - Virucidal activity against enveloped viruses and Norovirus. • Testing must be conducted in “dirty” conditions as prescribed in the standard. • Testing must be conducted with liquid extracted from the wipe. Wipes must be tested at laboratories that are UKAS or independent Equivalent accredited with BS EN 17025:2017. NHS Supply Chain may stipulate testing of Applicant’s Goods at the Applicant’s expense or request further information from the Applicant to ensure the Goods comply with the Specification at any time during the Tender or post tender. In the event that the product(s) do not meet the Specification, NHS Supply Chain will reserve the right to exclude the Goods from the Framework Agreement and/or the tender process (as the case may be). Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £1,971,091 Inc. VAT in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Lot 5: Disinfection Wipes This Lot is for Sterile Cleanroom Wipes that are impregnated with a solution that contains disinfectant liquid and/or alcohol but can also contain other active ingredients for the disinfection of surfaces and/or non-invasive medical devices. All products must be suitable for use in the Healthcare and Healthcare related environment, typically within the NHS sector. All products must meet current standards and Regulations: BS EN 16615:2015 Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and Yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test). Test method and requirements (phase 2, step 2) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Testing must be conducted in “clean” conditions as prescribed in the standard. BS EN 14476:2013+A2:2019 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Testing must be conducted in “clean” conditions as prescribed in the standard • Minimum spectrum of test organisms - Virucidal activity against enveloped viruses and Norovirus, Alcohol products are exempt from testing Norovirus. • Testing must be conducted with liquid extracted from the wipe And where applicable and available the following: BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation — Requirements for development, validation and routine control of a sterilization process for medical devices. BS EN ISO 17665:2024 Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices. BS EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated ""STERILE"" — Requirements for aseptically processed medical devices BS EN 16777:2018 Chemical disinfectants and antiseptics. Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase 2/step 2). BS EN 14885:2022 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics. Wipes must be tested at laboratories that are UKAS or independent Equivalent accredited with BS EN 17025:2017. NHS Supply Chain may stipulate testing of Applicant’s Goods at the Applicant’s expense or request further information from the Applicant to ensure the Goods comply with the Specification at any time during the Tender or post tender. In the event that the product(s) do not meet the Specification, NHS Supply Chain will reserve the right to exclude the Goods from the Framework Agreement and/or the tender process (as the case may be). Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £5,046,787 Inc. VAT in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Lot 6: Sterile Cleanroom Wipes This Lot is for Sterile Cleanroom Wipes that are impregnated with a solution that contains disinfectant liquid and/or alcohol but can also contain other active ingredients for the disinfection of surfaces and/or non-invasive medical devices. All products must be suitable for use in the Healthcare and Healthcare related environment, typically within the NHS sector. All products must meet current standards and Regulations: BS EN 16615:2015 Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and Yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test). Test method and requirements (phase 2, step 2) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Testing must be conducted in “clean” conditions as prescribed in the standard. BS EN 14476:2013+A2:2019 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1) Amendment to the standard requirements: • The maximum contact time must be 2 minutes or shorter • Testing must be conducted in “clean” conditions as prescribed in the standard • Minimum spectrum of test organisms - Virucidal activity against enveloped viruses and Norovirus, Alcohol products are exempt from testing Norovirus. • Testing must be conducted with liquid extracted from the wipe And where applicable and available the following: BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation — Requirements for development, validation and routine control of a sterilization process for medical devices. BS EN ISO 17665:2024 Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices. BS EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" — Requirements for aseptically processed medical devices BS EN 16777:2018 Chemical disinfectants and antiseptics. Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase 2/step 2). BS EN 14885:2022 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics. Wipes must be tested at laboratories that are UKAS or independent Equivalent accredited with BS EN 17025:2017. NHS Supply Chain may stipulate testing of Applicant’s Goods at the Applicant’s expense or request further information from the Applicant to ensure the Goods comply with the Specification at any time during the Tender or post tender. In the event that the product(s) do not meet the Specification, NHS Supply Chain will reserve the right to exclude the Goods from the Framework Agreement and/or the tender process (as the case may be). Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £1,272,000 Inc. VAT in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement.