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EN ISO 10993-18:2020 Standard

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  Keywords:

#amendment #main #medical #text #can

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

  Purpose

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 10993-18:2020/A1:2023 modifies the European standard EN ISO 10993-18:2020. In this amendment, you can find the relationship between EN ISO 10993-18:2020 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.

  Publication

Wednesday 14th of April 2021

  Related Standards

EN ISO 11607-1:2009

Active implantable medical devices Directive (90/385/EEC)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 10993-12:2012

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

EN ISO 11137-1:2015

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 10993-16:2017

Active implantable medical devices Directive (90/385/EEC)

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

EN ISO 11607-1:2020

Active implantable medical devices Directive (90/385/EEC)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 14155:2020

Active implantable medical devices Directive (90/385/EEC)

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

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