BAS EN ISO 10993-12:2002
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
General Information
Status: Withdrawn
No. of pages: 20
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 22.03.2002
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
93/42/EEC, Medical devices
...
Abstract
This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include: a) test material selection; b) selection of representative portions from a device; c) test sample preparation; d) the selection of reference materials to demonstrate the suitability of the test system and/or to enable relative comparison of the biological activity of the test sample; and, e) preparation of extracts.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-12:1996, identical
- ISO 10993-12:1996, identical