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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: 15 February 2010
Status: inactive
Page Count: 20
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 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
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 references:
ISO 10993-18 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Published by ISO on January 1, 2020
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation...
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 is referenced by:
EN ISO 25539-3 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Published by CEN on December 1, 2011
This part of ISO 25539 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes,...
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:
AAMI 10993-13 - Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Published by AAMI on January 1, 2010
This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices...
This document is referenced by:
EN ISO 25539-2 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Published by CEN on September 1, 2020
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information...
This document is referenced by:
SN EN ISO 15798 - Ophthalmic implants - Ophthalmic viscosurgical devices
Published by SNV on February 1, 2022
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in...
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