SS-EN-ISO-10993-17 › Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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This part of ISO 10993 specifies a method for 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). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
Active implantable medical devices. Medical devices
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Designation Name
SS-EN ISO 10993-17:2009
Revision Level
2009 EDITION
Status
Current
Publication Date
May 8, 2009
Language(s)
English
Page Count
40
International Equivalent
EN ISO 10993-17:2009(IDT); ISO 10993-17:2002(IDT)