I.S. EN 556-1:2001&AC:2006
Superseded
View Superseded by
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Hardcopy , PDF
English
01-01-2009
09-04-2024
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 |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 556-1:2001/AC:2006 | Identical |
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