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EN ISO 10993-12:2012 Standard

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  Keywords:

#selection #part #live #device #requirements

  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 12: Sample preparation and reference materials (ISO 10993-12:2012)

  Purpose

This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: - test sample selection; - selection of representative portions from a device; - test sample preparation; - experimental controls; - selection of, and requirements, for reference materials; - preparation of extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-12:2009"

Anyway is still possible use the "EN ISO 10993-12:2009" until January 31st, 2013

  Related Standards

EN ISO 10993-6:2009

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

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 14155:2011/AC:2011

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

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 13408-2:2018

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Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

EN ISO 11137-1:2015/A2:2019

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 10993-11:2018

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

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

EN ISO 17665-1:2006

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

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

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