SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 8537:2016

UNE-EN ISO 8537:2016

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Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

€86.00

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UNE-EN ISO 6009:2017

UNE-EN ISO 6009:2017

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Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

€58.00

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UNE-EN ISO 7864:2017

UNE-EN ISO 7864:2017

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Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

€82.00

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UNE-EN ISO 9626:2017

UNE-EN ISO 9626:2017

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Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

€79.00

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UNE-EN ISO 80369-3:2017

UNE-EN ISO 80369-3:2017

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Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)

€104.00

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UNE-EN 80369-5:2017

UNE-EN 80369-5:2017

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Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

€100.00

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UNE-EN ISO 11138-3:2017

UNE-EN ISO 11138-3:2017

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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)

€69.00

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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 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 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 11737-1:2018

UNE-EN ISO 11737-1:2018

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

€126.00

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UNE-EN ISO 10993-11:2018

UNE-EN ISO 10993-11:2018

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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

€96.00

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UNE-EN 13976-1:2019

UNE-EN 13976-1:2019

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Rescue systems - Transportation of incubators - Part 1: Interface requirements

€61.00

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UNE-EN 13976-2:2019

UNE-EN 13976-2:2019

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Rescue systems - Transportation of incubators - Part 2: System requirements

€60.00

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