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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 10993-1:2009/AC:2010

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

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-17:2009

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

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 11737-1:2006/AC:2009

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 11737-1:2006

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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 11137-2:2015

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

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

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