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.
Directives related to this standards.
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
Harmonized
WITHDRAWN
SSH EN ISO 10993-12:2009
95.99
Withdrawal of Standard
May 17, 2013
PUBLISHED
SSH EN ISO 10993-12:2012
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