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SN EN 554 : 1995

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 STERILIZATION BY MOIST HEAT
Superseded date

11-01-2006

Published date

01-12-2013

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. (informative) Guidance on the application of EN 554
B. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references

Specifies requirements for the process development, validation, process control, and monitoring of the sterilisation of medical devices using moist heat. Does not describe a quality assurance system for the control of all stages of manufacture. Also gives definitions and annexes.

DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded

Standards Relationship
I.S. EN 554:1994 Identical
UNE-EN 554:1995 Identical
DIN EN 554:1994-11 Identical
BS EN 554:1994 Identical
EN 554 : 1994 Identical

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