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ISO 10993-10 FRENCH

Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de sensibilisation cutanée

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Organization: ISO
Publication Date: 1 August 2010
Status: active
Page Count: 76
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

ISO 10993-10 FRENCH
August 1, 2010
Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de sensibilisation cutanée
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:
88/379/EEC - Council Directive on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Classification, Packaging and Labelling of Dangerous Preparations
Published by EU on January 1, 1988
A description is not available for this item.
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 10993-13 - 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 10993-2 - 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:
ISO 25841 - Female condoms — Requirements and test methods AMENDMENT 1
Published by ISO on April 1, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-12 - Biological evaluation of medical devices Part 12: Sample preparation and reference materials
Published by BSI on October 31, 2012
A description is not available for this item.
This document is referenced by:
ISO 9394 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
Published by ISO on October 1, 2012
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of...
This document is referenced by:
ISO 9394 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
Published by ISO on October 1, 2012
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of...
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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