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I.S. EN 552:1994

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION

Available format(s)

Hardcopy , PDF

Superseded date

07-07-2006

Language(s)

English

Published date

01-01-1994

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

US$89.15
Excluding Tax where applicable

Foreword
Foreword to amendment A1
Foreword to amendment A2
Introduction
1 Scope
2 Normative references
3 Definitions
4 General
5 Validation
6 Process control and monitoring
7 Product release from sterilization (parametric release)
Annex A (informative) Guidance on the application of EN 552
Annex B (informative) Bibliography

Specifies requirements for the validation, process control and monitoring of the radiation sterilisation of medical devices.

DocumentType
Standard
Pages
60
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

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