I.S. EN 556-1:2002
Superseded
View Superseded by
STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES
Hardcopy , PDF
English
01-18-2002
01-01-2009
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
Specifies the requirements for a terminally-sterilised medical device to be designated "STERILE".
| Committee |
TC 204
|
| DevelopmentNote |
Supersedes I.S. EN 556 (03/2003)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 556-1 : 2002 | Identical |
| NEN EN 556-1 : 2001 C1 2006 | Identical |
| DIN EN 556-1:2002-03 | Identical |
| NS EN 556-1 : 2002 AC 2006 | Identical |
| BS EN 556-1:2001 | Identical |
| NBN EN 556-1 : 2001 COR 2006 | Identical |
| EN 556-1:2001/AC:2006 | Identical |
| UNE-EN 556-1:2002 | Identical |
A newer version of this standard is available.
View Current Edition