ISO 10993-1:2009
Withdrawn
Withdrawn
View Superseded by
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Amended by
Available format(s)
Hardcopy , PDF
Published date
10-13-2009
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
Summarise this standard
AI-generated summary
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Withdrawn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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US$96.00
Excluding Tax where applicable
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