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EN ISO 13485:2016 Standard

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  Keywords:

#requirements #eu #relationship #can #amendment

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

    In vitro diagnostic medical devices Directive (98/79/EC)

      Last Official Journal reference

    Thursday 15th of April 2021

      Description:

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

      Purpose

    ISO 13485 specifies the requirements of a quality management system for medical devices. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN ISO 13485:2016/A11:2021 modifies the European standard EN ISO 13485:2016. EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. The relationship with EU Regulations can be found in informative annexes. In this amendment you can find:— Annex ZA which covers the relationship between EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745.— Annex ZB which covers the relationship between EN ISO 13485 and the requirements of Regulation (EU) 2017/746.

      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

    EN ISO 13408-4:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 13408-7:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN 14820:2004

    In vitro diagnostic medical devices Directive (98/79/EC)

    Single-use containers for human venous blood specimen collection

    EN 14254:2004

    In vitro diagnostic medical devices Directive (98/79/EC)

    In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

    EN 14136:2004

    In vitro diagnostic medical devices Directive (98/79/EC)

    Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

    EN 13975:2003

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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