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UNE-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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

01-06-2010

Superseded by

UNE-EN ISO 11135-1:2007

Language(s)

Spanish, Castilian

Published date

13-03-1995

€78.00
Excluding VAT

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.

Committee
CTN 111
DocumentType
Standard
Pages
40
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 550 : 1995 Identical
NF EN 550 : 1994 Identical
EN 550 : 1994 Identical
NEN EN 550 : 1994 Identical
I.S. EN 550:1994 Identical
UNI EN 550 : 1996 Identical
SN EN 550 : 1995 Identical
BS EN 550:1994 Identical
NS EN 550 : 1ED 1994 Identical
DIN EN 550:1994-11 Identical

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