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ISO - ISO 13485 — Medical devices

    https://www.iso.org/iso-13485-medical-devices.html
    A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Who is ISO 13485 for? ISO 13485 is designed to …

ISO - ISO 13485:2016 - Medical devices — Quality …

    https://www.iso.org/standard/59752.html
    It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development …

ISO - New ISO standards for medical devices

    https://www.iso.org/news/ref2534.html
    ISO 20417, Medical devices – Information to be supplied by the manufacturer, simplifies the process of meeting product information regulations …

ISO - ISO 20417:2021 - Medical devices — Information …

    https://www.iso.org/standard/67943.html
    This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined …

Medical devices - ISO

    http://policy.iso.org/medical-devices.html
    Medical devices. The medical devices industry, with products ranging from implantable cardiac pacemakers to wheelchairs, and from diagnostic test systems to syringes …

Ultimate List of ISO Standards for Medical Devices

    https://www.greenlight.guru/blog/iso-standards
    Oct 5, 2022

ISO 13485 - Wikipedia

    https://en.wikipedia.org/wiki/ISO_13485
    Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, …

ISO - ISO 15223-1:2021 - Medical devices — Symbols to …

    https://www.iso.org/standard/77326.html
    Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. This document specifies symbols used to express …

ISO Certification for Medical Devices | ISO …

    https://www.siscertifications.com/medical-devices/
    The most required ISO standards that are appropriate for medical devices are listed below: ISO 9001 Standard ISO 9001 certification is an internationally recognized standard for …

Sterilization for Medical Devices | FDA

    https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
    Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other …



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