DSF/PREN ISO 10993-12
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019)
active, Most Current
Buy Now
| Organization: | DS |
| Status: | active |
| Page Count: | 35 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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 test systems onlyin accordance with one or more parts of ISO 10993. Specifically, this document addresses the following: - test sample selection; - selection of representative portions from a medical device; - test sample preparation; - experimental controls; - selection of, and requirements, for reference materials; - preparation of extracts. This document is not applicable to live cells, but can be relevant to the material or medical device components of combination products containing live cells.
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.
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...
DSF/PREN ISO 10993-12
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.