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ISO 10993-7 FRENCH

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène

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Organization: ISO
Publication Date: 15 October 2008
Status: active
Page Count: 104
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

ISO 10993-7 FRENCH
December 1, 2019
AMENDEMENT 1 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals AMENDMENT 1: Applicability of allowable limits for neonates and infants
A description is not available for this item.
ISO 10993-7 FRENCH
November 15, 2009
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène RECTIFICATIF TECHNIQUE 1
A description is not available for this item.
ISO 10993-7 FRENCH
October 15, 2008
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène
A description is not available for this item.

References

This document references:
EN 550 - Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
Published by CEN on January 1, 1994
A description is not available for this item.
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:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
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...
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