ISO 10993-17:2002
Withdrawn
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Hardcopy , PDF
English, French
11-27-2002
04-09-2025
ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.
| DevelopmentNote |
Supersedes ISO/DIS 10993-17. (12/2002)
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ANSI/AAMI/ISO 10993-17:2002(R2012) | Identical |
| DIN EN ISO 10993-17:2009-08 | Identical |
| AAMI ISO 10993-17 : 2002 | Identical |
| GOST ISO 10993-17 : 2011 | Identical |
| NBN EN ISO 10993-17 : 2009 | Identical |
| NEN EN ISO 10993-17 : 2009 | Identical |
| NS EN ISO 10993-17 : 2009 | Identical |
| I.S. EN ISO 10993-17:2009 | Identical |
| PN EN ISO 10993-17 : 2009 | Identical |
| AS ISO 10993.17-2004 | Identical |
| SS-EN ISO 10993-17:2009 | Identical |
| BS EN ISO 10993-17:2009 | Identical |
| EN ISO 10993-17:2009 | Identical |
| NF EN ISO 10993-17 : 2009 | Identical |
| BS EN ISO 10993-17:2002 | Equivalent |
| UNE-EN ISO 10993-17:2009 | Identical |
| GOST R ISO 10993-17 : 2009 | Identical |
| BS EN ISO 10993-17:2002 | Identical |
| UNE-EN ISO 10993-17:2003 | Identical |
This standard has been withdrawn and is no longer current. No replacement edition is available.
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