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STANDARD

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ÖNORM EN ISO 10993-16

Issue date: 2010 06 15

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

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.

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General information on ÖNORM EN ISO 10993-16

Format

Digital | 20 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 10993-1:2018	Titel Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)	Ausgabedatum 2018 08 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-17:2002	Titel Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances	Ausgabedatum 2002 11 27	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-18:2020	Titel Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process	Ausgabedatum 2020 01 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-2:2006	Titel Biological evaluation of medical devices — Part 2: Animal welfare requirements	Ausgabedatum 2006 07 06	Art Standard	Zur Produktseite
Dokumentnummer ISO 14971:2019	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2019 12 10	Art Standard	Zur Produktseite

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