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AAMI/ISO 10993-17:2002 (R2012)
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substancesMore info
Specifies a method for determining allowable limits for leachable substances from medical devices and describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Intended for use in deriving standards and estimating appropriate limits where standards do not exist.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2012-11-30 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Cross references | ISO 10993-17 (2002-12), IDT |
| Year | 2002 |
| Document history | |
| Country | USA |
| Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-17-2002 (R2012) |