Superseded
Standard
Historical
DIN EN ISO 10993-17:2003-06
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2002.
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Summary
This part of ISO 10993 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. This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Notes
A transition period, as set out in DIN EN ISO 10993-17 (2009-08), exists until 2010-03-21.
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 06/01/2003 |
| Page Count | 31 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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