EN 552:1994/A2:2000
Superseded
View Superseded by
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
01-12-2013
04-01-2006
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
Gives requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. Specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. Does not cover radiation protection requirements associated with operating irradiation plants.
| Committee |
TC 204
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 552 : 95 AMD 2 2001 | Identical |
| NF EN 552 : 94 AMD 2 2001 | Identical |
| NEN EN 552 : 1995 AMD 2 2001 | Identical |
| NS EN 552 : 94 AMD 2 2001 | Identical |
| I.S. EN 552:1994 | Identical |
| DIN EN 552:2001-02 | Identical |
| DIN EN 552:1994-11 | Identical |