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NF EN 550 : 1994

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

23-07-2013

Published date

12-01-2013

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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Superseded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

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