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ISO 10993-16 FRENCH

Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables

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Organization: ISO
Publication Date: 1 May 2017
Status: active
Page Count: 22
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

ISO 10993-16 FRENCH
May 1, 2017
Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables
A description is not available for this item.
ISO 10993-16 FRENCH
February 15, 2010
Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables
A description is not available for this item.

References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
This document references:
10993-17 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
Published by ISO on September 1, 2023
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is...
This document is referenced by:
AAMI 10993-6 - Biological evaluation of medical devices-Part 6: Tests for local effects after implantation
Published by AAMI on January 1, 2016
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to...
This document is referenced by:
BS EN ISO 15798 - Ophthalmic implants - Ophthalmic viscosurgical devices
Published by BSI on September 30, 2013
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-13 - Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
Published by BSI on October 31, 2010
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-15 - Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
Published by BSI on May 31, 2023
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-14 - Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
Published by BSI on June 30, 2009
A description is not available for this item.
This document is referenced by:
BS EN ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Published by BSI on November 30, 2018
A description is not available for this item.
This document is referenced by:
ISO 18562-4 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Published by ISO on March 1, 2017
This document specifies tests for substances leached by liquid water condensing into GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care or...
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