I.S. EN 552:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
Hardcopy , PDF
07-07-2006
English
01-01-1994
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.
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Foreword
Foreword to amendment A1
Foreword to amendment A2
Introduction
1 Scope
2 Normative references
3 Definitions
4 General
5 Validation
6 Process control and monitoring
7 Product release from sterilization (parametric release)
Annex A (informative) Guidance on the application of EN 552
Annex B (informative) Bibliography
Specifies requirements for the validation, process control and monitoring of the radiation sterilisation of medical devices.
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 552:1994/A2:2000 | Identical |
| NF EN 552 : 94 AMD 2 2001 | Identical |
| NS EN 552 : 94 AMD 2 2001 | Identical |
| DIN EN 552:2001-02 | Identical |
| NBN EN 552 : 95 AMD 2 2001 | Identical |
| NEN EN 552 : 1995 AMD 2 2001 | Identical |
| UNI EN 552 : 2002 | Identical |
| SN EN 552 : 1995 AMD 2 2001 | Identical |
| DIN EN 552:1994-11 | Identical |
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