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NBN
NBN EN 550 : 1995

NBN EN 550 : 1995

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILISATIE VAN MEDISCHE HULPMIDDELEN - VALIDATIE EN ROUTINECONTROLE VAN ETHYLEENOXIDE - STERILISATIE

Superseded date

09-13-2007

Published date

01-12-2013

Publisher

Belgian Standards

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.

DocumentType
Standard
PublisherName
Belgian Standards
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Superseded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

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