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)

SS-EN-ISO-10993-16 - EDITION 1 - SUPERSEDED
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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:

11.020 (Medical sciences and health care facilities in general Including quality and environmental management in health care technology IT application in health care technology, see 35.240.80)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Designation Name

SS-EN ISO 10993-16

Revision Level

EDITION 1

Status

Superseded

Publication Date

Feb. 27, 1998

Language(s)

English

Page Count

14

International Equivalent

EN ISO 10993-16:1997(IDT); ISO 10993-16:1997(IDT)