Standard

NS-EN ISO 10993-12:2007

Mar 2008 Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-12:2021

Corrigendums and amendments are bought separately.

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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.

Document information

Standard from SN
Published: 1 March 2008
Withdrawn: 1 July 2009
Edition: 2007-11
Version: 1
Document type: NAT
ISBN:

ICS 11.100.20
National Committee SN/K 115

Legal references

EU law: 93/42/EEC, 90/385/EEC

Product Relations

Replaced by: NS-EN ISO 10993-12:2009
Replaces: NS-EN ISO 10993-12:2004
Adopted from: EN ISO 10993-12:2007 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-12:2004
Current product

Withdrawn

NS-EN ISO 10993-12:2007
Replaced by

Withdrawn

NS-EN ISO 10993-12:2009

NS-EN ISO 10993-12:2007

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NS-EN ISO 10993-12:2021

NS-EN ISO 10993-12:2012

NS-EN ISO 10993-12:2009