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ISO 10993-9 FRENCH

Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation

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Organization: ISO
Publication Date: 15 December 2009
Status: inactive
Page Count: 16
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

ISO 10993-9 FRENCH
November 1, 2019
Évaluation biologique des dispositifs médicaux — Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation
A description is not available for this item.
ISO 10993-9 FRENCH
December 15, 2009
Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation
A description is not available for this item.

References

This document references:
ISO 10271 - Dentistry — Corrosion test methods for metallic materials
Published by ISO on August 1, 2020
This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be...
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 10993-13 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Published by ISO on June 15, 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 references:
ISO 10993-14 - Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics
Published by ISO on November 15, 2001
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the...
This document references:
ISO 10993-15 - Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
Published by ISO on November 1, 2019
This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples...
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...
This document is referenced by:
SN EN ISO 10451 - Dentistry - Contents of technical file for dental implant systems
Published by SNV on September 1, 2010
This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part...
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:
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:
EN ISO 25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
Published by CEN on March 1, 2017
This document specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information...
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