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ISO 10993-1 FRENCH

Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque

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Organization: ISO
Publication Date: 1 August 2018
Status: active
Page Count: 54
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

ISO 10993-1 FRENCH
August 1, 2018
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
A description is not available for this item.
ISO 10993-1 FRENCH
August 1, 2018
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
A description is not available for this item.
ISO 10993-1 FRENCH
June 15, 2010
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque RECTIFICATIF TECHNIQUE 1
A description is not available for this item.
ISO 10993-1 FRENCH
October 15, 2009
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
A description is not available for this item.

References

This document references:
ISO 9001 - Quality management systems — Requirements
Published by ISO on September 15, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document references:
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Published by ISO on September 1, 2017
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
This document references:
ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by ISO on May 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
This document references:
ISO 9004 - Quality management - Quality of an organization - Guidance to achieve sustained success
Published by ISO on April 1, 2018
This document gives guidelines for enhancing an organization’s ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015. This...
This document is referenced by:
BS EN ISO 11608-2 - Needle-based injection systems for medical use - Requirements and test methods Part 2: Double-ended pen needles
Published by BSI on July 31, 2022
A description is not available for this item.
This document is referenced by:
JIS T 60601-2-65 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Published by JSA on March 1, 2019
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-4 - Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
Published by BSI on May 31, 2017
A description is not available for this item.
This document is referenced by:
BS EN ISO 14630 - Non-active surgical implants - General requirements
Published by BSI on December 31, 2012
A description is not available for this item.
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