ISO 10993-1:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices — Part 1: Evaluation and testing
Hardcopy , PDF
English, French
28-07-2003
02-11-2025
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Withdrawn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 | Identical |
| BS EN ISO 10993-1:June 2009 | Identical |
| JIS T 0993-1:2005 | Identical |
| UNE-EN ISO 10993-1:2004 | Identical |
| NASA-STD-8719.27:2022 | IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| I.S. EN ISO 11137-1:2015/A2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018) |
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