ISO 10993-1:2003
Withdrawn
View Superseded by
Biological evaluation of medical devices — Part 1: Evaluation and testing
Hardcopy , PDF
English, French
07-28-2003
11-02-2025
ISO 10993-1:2003 describes
- the general principles governing the biological evaluation of medical devices;
- the categorization of devices based on the nature and duration of their contact with the body;
- the selection of appropriate tests.
It does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
Other parts of ISO 10993 cover specific tests.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS EN ISO 10993-1:2003 | Equivalent |
| I.S. EN ISO 10993-1:2003 | Equivalent |
| DIN EN ISO 10993-1:2003-12 | Equivalent |
| BS EN ISO 10993-1:2003 | Identical |
| BS EN ISO 10993-1:June 2009 | Identical |
| JIS T 0993-1:2005 | Identical |
| UNE-EN ISO 10993-1:2004 | Identical |
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