EN ISO 10993-12:2009

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) EN ISO 10993-12:2009

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Jul 1, 2012

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

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EN ISO 10993-12:2007

NOW

WITHDRAWN
EN ISO 10993-12:2009
99.60 Withdrawal effective
Jul 1, 2012

REVISED BY

WITHDRAWN
EN ISO 10993-12:2012

Relations

Adopted from ISO 10993-12:2007 IDENTICAL