STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION

Superseded date

07-23-2013

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

Cooperating organizations
National foreword
Foreword
Introduction
1. Scope
2. Normative references
3. Definitions
4. General
5. Validation
6. Process control and monitoring
7. Product release from sterilization
Annexes
A. (normative) Method for calculating D-values using
microbiological performance qualification method B
B. (informative) Guidance on the application of EN 550
C. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references

Specifies requirements for the development, validation, process control and monitoring of the sterilisation of medical devices using ethylene oxide. Coverage includes definitions, validation, product release from sterilisation, and process control and monitoring. Also gives detailed annexes.

DevelopmentNote	INDICE DE CLASSEMENT: S98101
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Superseded

Standards	Relationship
UNE-EN 550:1995	Identical
I.S. EN 550:1994	Identical
EN 550 : 1994	Identical
BS EN 550:1994	Identical
DIN EN 550:1994-11	Identical

FD S98 135 : 2005 FD	STERILISATION OF MEDICAL DEVICES - GUIDELINES FOR THE CONTROL OF THE TREATMENTS APPLIED TO THE RE-USABLE MEDICAL DEVICES
XP S94 091 : 2008 XP	IMPLANTS FOR SURGERY - VALIDATION OF THE CLEANING OF ORTHOPAEDIC IMPLANTS BEFORE FINAL CONDITIONING