ISO 10993-12
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
inactive
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| Organization: | ISO |
| Publication Date: | 15 November 2007 |
| Status: | inactive |
| Page Count: | 24 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of ISO 10993 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 this part of ISO 10993 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.
This part of ISO 10993 is not applicable to materials or devices containing live cells.
Document History
January 1, 2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
July 1, 2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This part of ISO 10993 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...
ISO 10993-12
November 15, 2007
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
This part of ISO 10993 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...
December 15, 2002
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
A description is not available for this item.
December 15, 2002
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in...
September 15, 1996
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
A description is not available for this item.