Standard

ISO 10993-12:2007

Oct 2007 Withdrawn

Note: Latest version: ISO 10993-12:2021

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Abstract

ISO 10993-12:2007 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 the ISO 10993 series. Specifically ISO 10993-12:2007 addresses: 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. ISO 10993-12:2007 is not applicable to materials or devices containing live cells.

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Standard from ISO
Published: October 31 2007
Withdrawn: June 29 2012
Period for objection until: June 27 2006
Edition: 3
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

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Revised by: ISO 10993-12:2012
Adopted by: NF EN ISO 10993-12:2009
Adopted by: SN EN ISO 10993-12:2009
Adopted by: NF EN ISO 10993-12:2008
Adopted by: SN EN ISO 10993-12:2008
Revises: ISO 10993-12:2002

ISO 10993-12:2007

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ISO 10993-12:2021

ISO 10993-12:2012

ISO 10993-12:2007

ISO 10993-12:2002

ISO 10993-12:1996

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Version history History (5)

ISO 10993-12:2021

ISO 10993-12:2012

ISO 10993-12:2007

ISO 10993-12:2002

ISO 10993-12:1996

Abstract

Products specifications

Product Relations

Product life cycle