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I.S. EN 556-1:2001&AC:2006

Current
Current

The latest, up-to-date edition.

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

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.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives
Bibliography

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated
‘STERILE’. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".

Committee
TC 204
DocumentType
Standard
Pages
16
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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£17.39
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