NEN-ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 April 2003 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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 appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
Document History
NEN-ISO 10993-12
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...
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...