DS/EN ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
inactive
| Organization: | DS |
| Publication Date: | 13 October 2005 |
| Status: | inactive |
| Page Count: | 30 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of the standard 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 biological systems in accordance with one or more parts of this series
Specifically, this part addresses:
- test material selection;
- selection of representative portions of a device;
- test sample preparation;
- experimental controls;
- selection of and requirements for reference materials; and
- preparations of extracts.
The applicability of this part to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
Document History
June 21, 2021
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
This document 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...
August 13, 2012
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
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...
June 15, 2009
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 20, 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...
March 1, 2006
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
A description is not available for this item.
DS/EN ISO 10993-12
October 13, 2005
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This part of the standard 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...
January 15, 1997
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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...
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019)
This document 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 evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
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 evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/FDIS 10993-12:2012)
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 evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2010)
A description is not available for this item.
References
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