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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 10993-18:2009

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

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

EN ISO 14971:2012

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

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN ISO 13408-1:2015

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

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN ISO 13408-3:2011

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

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

EN ISO 13408-4:2011

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

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

EN ISO 13408-5:2011

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

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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