SN EN 552 : 1995 AMD 2 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
01-06-2006
12-01-2013
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.
| DocumentType |
Standard
|
| PublisherName |
Swiss Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| DIN EN 552:1994-11 | Identical |
| DIN EN 552:2001-02 | Identical |
| EN 552:1994/A2:2000 | Identical |
| I.S. EN 552:1994 | Identical |
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