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STANDARD

Withdrawn

ÖNORM EN ISO 10993-16

Issue date: 1998 03 01

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

This part of IS0 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.

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General information on ÖNORM EN ISO 10993-16

Format

Digital | 17 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 10993-16 from 1998 til today.

• ÖNORM EN ISO 10993-16

  2018 01 15 Standard ÖNORM EN ISO 10993-16, Edition: 2018 01 15

  Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
• ÖNORM EN ISO 10993-16

  2010 06 15 Standard ÖNORM EN ISO 10993-16, Edition: 2010 06 15

  Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
• ÖNORM EN ISO 10993-16

  2009 09 15 Standard ÖNORM EN ISO 10993-16, Edition: 2009 09 15

  Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
• ÖNORM EN ISO 10993-16

  1998 03 01 Standard ÖNORM EN ISO 10993-16, Edition: 1998 03 01

  Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 10993-1:1992	Titel Biological evaluation of medical devices — Part 1: Guidance on selection of tests	Ausgabedatum 1992 04 23	Art Standard	Zur Produktseite

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