ISO 10993-1:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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 within a risk management process
Hardcopy , PDF
13-10-2009
09-04-2025
ISO 10993-1:2009 describes:
- the general principles governing the biological evaluation of medical devices within a risk management process;
- the general categorization of devices based on the nature and duration of their contact with the body;
- the evaluation of existing relevant data from all sources;
- the identification of gaps in the available data set on the basis of a risk analysis;
- the identification of additional data sets necessary to analyse the biological safety of the medical device;
- the assessment of the biological safety of the medical device.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN-EN-ISO 10993-1:2009-10 | Identical |
| SS-EN ISO 10993-1:2009 | Identical |
| PN-EN ISO 10993-1:2010 | Identical |
| DIN EN ISO 10993-1:2009-10 | Equivalent |
| BS EN ISO 10993-1:2009 | Equivalent |
| DIN EN ISO 10993-1:2010-04 | Identical |
| AAMI ISO 10993-1:2009 | Identical |
| NEN EN ISO 10993-1 : 2009 C1 2010 | Identical |
| GOST R ISO 10993-1 : 2009 | Identical |
| UNE-EN 30993-1:1994 | Identical |
| DIN EN 30993-1:1994-12 | Similar to |
| NF EN ISO 10993-1 : 2010 | Identical |
| EN ISO 10993-1:2009 | Identical |
| PN EN ISO 10993-1 : 2010 AC 2010 | Identical |
| UNE-EN ISO 10993-1:2010 | Identical |
| BS EN ISO 10993-1:2009 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| GOST ISO 10993-1 : 2011 | Identical |
| NEN ISO 10993-1 : 1994 | Similar to |
| BS EN 30993-1:1994 | Similar to |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| I.S. EN ISO 10993-1:2009+AC:2010 | Identical |
| NBR ISO 10993-1 : 2013 | Identical |
| AAMI ISO 10993-1 : 2009 : R2013 | Identical |
| EN 30993-1 : 1994 | Similar to |
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