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ISO 10993-17:2002

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

Standard Details

ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving StandardDetails and estimating appropriate limits where StandardDetails 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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 10993-17:2002
Document Year: 2002
Pages: 25
Edition: 1
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

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WITHDRAWN
ISO 10993-17:2002
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