NEN-ISO 10993-1
Biological evaluation of medical devices - Part 1: Guidance on selection of tests
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 November 1994 |
| Status: | inactive |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of contact with the body; c) the selection of appropriate tests. ISO 10993 does not cover testing of materials and devices that do not come into contact with the patient's body directly or indirectly. Nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword.
Document History
NEN-ISO 10993-1
November 1, 1994
Biological evaluation of medical devices - Part 1: Guidance on selection of tests
This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and...