SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 80369-7:2017

UNE-EN ISO 80369-7:2017

Superseded Historical

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)

€110.00

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UNE-EN 12791:2016+A1:2018 (R2022)

UNE-EN 12791:2016+A1:2018 (R2022)

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Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)

€85.00

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UNE-EN ISO 10993-4:2018

UNE-EN ISO 10993-4:2018

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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

€133.00

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UNE-EN ISO 11608-7:2018

UNE-EN ISO 11608-7:2018

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Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)

€78.00

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UNE-EN ISO 10555-1:2013/A1:2018

UNE-EN ISO 10555-1:2013/A1:2018

Superseded Historical

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)

€35.00

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UNE-EN ISO 10555-6:2018

UNE-EN ISO 10555-6:2018

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Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

€76.00

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UNE-EN ISO 10993-16:2018

UNE-EN ISO 10993-16:2018

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

€73.00

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UNE-EN ISO 11137-3:2018

UNE-EN ISO 11137-3:2018

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Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

€103.00

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UNE-EN ISO 17664:2018

UNE-EN ISO 17664:2018

Superseded Historical

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

€83.00

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UNE-EN ISO 13485:2018

UNE-EN ISO 13485:2018

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)

€123.00

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UNE-EN ISO 80601-2-56:2018

UNE-EN ISO 80601-2-56:2018

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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 (ISO 80601-2-56:2017)

€118.00

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UNE-EN ISO 13408-2:2018

UNE-EN ISO 13408-2:2018

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Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

€100.00

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UNE-EN ISO 15378:2018

UNE-EN ISO 15378:2018

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Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

€134.00

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UNE-EN ISO 8536-14:2018

UNE-EN ISO 8536-14:2018

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Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

€62.00

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UNE-EN ISO 80369-6:2016

UNE-EN ISO 80369-6:2016

Superseded Historical

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15)

€105.00

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