I.S. EN 556-1:2001&AC:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
04-09-2024
English
01-01-2009
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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Superseded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 |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN ISO 14160:2011 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
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