SURGICAL AND MEDICAL DEVICES

UNE-EN 16437:2014+A1:2020

UNE-EN 16437:2014+A1:2020

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Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

€89.00

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UNE-EN ISO 11135:2015/A1:2020

UNE-EN ISO 11135:2015/A1:2020

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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

€69.00

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UNE-EN ISO 11137-1:2015/A2:2020

UNE-EN ISO 11137-1:2015/A2:2020

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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

€69.00

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UNE-EN 17122:2020

UNE-EN 17122:2020

Superseded Historical

Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2

€88.00

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UNE-EN ISO 80601-2-56:2018/A1:2020

UNE-EN ISO 80601-2-56:2018/A1:2020

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Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)

€40.00

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UNE-EN 13697:2015+A1:2020

UNE-EN 13697:2015+A1:2020

Superseded Historical

Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2, step 2)

€91.00

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UNE-EN ISO 11607-1:2020

UNE-EN ISO 11607-1:2020

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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

€106.00

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UNE-EN ISO 11607-2:2020

UNE-EN ISO 11607-2:2020

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

€69.00

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UNE-EN ISO 14971:2020

UNE-EN ISO 14971:2020

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

€98.00

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UNE-EN ISO 8536-4:2020

UNE-EN ISO 8536-4:2020

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Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

€76.00

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UNE-EN ISO 25424:2020

UNE-EN ISO 25424:2020

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Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

€115.00

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UNE-EN 14079:2004 ERRATUM (R2011)

UNE-EN 14079:2004 ERRATUM (R2011)

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Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

€0.00

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UNE-EN ISO 8871-3:2004

UNE-EN ISO 8871-3:2004

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Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

€53.00

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UNE-EN ISO 8871-1:2005

UNE-EN ISO 8871-1:2005

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Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

€71.00

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UNE-EN ISO 8871-2:2005

UNE-EN ISO 8871-2:2005

Superseded Historical

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)

€73.00

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