NEN-ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
inactive
| Organization: | NEN |
| Publication Date: | 1 October 1994 |
| Status: | inactive |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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 select ion; 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.
Document History
April 1, 2003
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating...
NEN-ISO 10993-12
October 1, 1994
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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...