SS-EN-ISO-10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

SS-EN-ISO-10993-12 - 2012 EDITION - CURRENT
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ISO 10993-12:2012 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, ISO 10993-12:2012 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. ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

To find similar documents by classification:

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)


Active implantable medical devices. Medical devices. 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

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Designation Name

SS-EN ISO 10993-12:2012

Revision Level

2012 EDITION

Status

Current

Publication Date

July 16, 2012

Language(s)

English

Page Count

36

International Equivalent

EN ISO 10993-12:2012(IDT); ISO 10993-12:2012(IDT)