I.S. EN 556-1:2024
Current
Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices
Hardcopy , PDF
English
07-04-2024
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.
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
Bibliography
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of EN 566 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
| Committee |
CEN/TC 204
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN 556-1:2024-09 | Equivalent |
| BS EN 556-1:2024 | Equivalent |
| EN 556-1:2024 | Identical |
| EN 556-1:2001 | Identical |
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