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EN ISO 13485:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

This standard can be totally or partially supervised by:
  •   EN ISO 13485:2016/AC:2016
  •   EN ISO 13485:2016/AC:2018
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

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

      Purpose

    Corrigendum for EN ISO 13485:2016

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN ISO 13485:2012"

    Anyway is still possible use the "EN ISO 13485:2012" until March 31st, 2019

      Related Standards

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    EN ISO 22442-2:2020

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    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-...

    EN ISO 22442-1:2020

    Medical devices Directive (93/42/EEC)

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

    EN ISO 14607:2018

    Medical devices Directive (93/42/EEC)

    Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

    EN ISO 14155:2020

    Medical devices Directive (93/42/EEC)

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

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