DIN EN 552:2001-02
Superseded
View Superseded by
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
01-12-2013
07-01-2006
DIN EN ISO 11137-1:2015-11
DIN EN ISO 11137-3:2015-08 (Draft)
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
This standard is included in DIN Handbook 263. 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.
| DocumentType |
Standard
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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| 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Superseded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 |
| I.S. EN 552:1994 | Identical |
| NBN EN 552 : 95 AMD 2 2001 | Identical |
| NEN EN 552 : 1995 AMD 2 2001 | Identical |