SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 11737-1:2018/A1:2022

UNE-EN ISO 11737-1:2018/A1:2022

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Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

€59.00

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UNE-EN ISO 13408-6:2022

UNE-EN ISO 13408-6:2022

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Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

€91.00

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UNE-EN 17387:2022

UNE-EN 17387:2022

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Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

€91.00

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UNE-EN ISO 11138-8:2022

UNE-EN ISO 11138-8:2022

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Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

€61.00

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UNE-EN ISO 15223-1:2022

UNE-EN ISO 15223-1:2022

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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

€118.00

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UNE-EN ISO 22413:2022

UNE-EN ISO 22413:2022

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Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)

€69.00

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UNE-EN ISO 10993-9:2022

UNE-EN ISO 10993-9:2022

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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

€69.00

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UNE-EN ISO 80369-7:2022

UNE-EN ISO 80369-7:2022

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Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

€109.00

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UNE-EN ISO 15883-5:2022

UNE-EN ISO 15883-5:2022

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Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

€126.00

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UNE-EN ISO 17664-1:2022

UNE-EN ISO 17664-1:2022

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Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

€85.00

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UNE-EN ISO 14971:2020/A11:2022

UNE-EN ISO 14971:2020/A11:2022

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

€53.00

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UNE-EN 16616:2015

UNE-EN 16616:2015

Superseded Historical

Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)

€83.00

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UNE-EN ISO 3826-4:2015

UNE-EN ISO 3826-4:2015

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Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

€90.00

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UNE-EN ISO 13408-7:2015

UNE-EN ISO 13408-7:2015

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Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

€77.00

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UNE-EN 13727:2012+A2:2015 (R2018)

UNE-EN 13727:2012+A2:2015 (R2018)

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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)

€100.00

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