SS-EN-ISO-10993-16 › Historical Revision Information
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
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This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
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 10993-16:2009
Revision Level
2009 EDITION
Status
Superseded
Publication Date
May 8, 2009
Language(s)
English
Page Count
24
International Equivalent
EN ISO 10993-16:2009(IDT); ISO 10993-16:1997(IDT)