I.S. EN 550:1994
Superseded
View Superseded by
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
Hardcopy , PDF
English
01-01-1994
08-22-2007
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.
Cooperating organizations
National foreword
Foreword
Introduction
1. Scope
2. Normative references
3. Definitions
4. General
5. Validation
6. Process control and monitoring
7. Product release from sterilization
Annexes
A. (normative) Method for calculating D-values using
microbiological performance qualification method B
B. (informative) Guidance on the application of EN 550
C. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references
Specifies requirements for the development, validation, process control and monitoring of the sterilisation of medical devices using ethylene oxide.
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 550 : 1995 | Identical |
| NF EN 550 : 1994 | Identical |
| EN 550 : 1994 | Identical |
| NEN EN 550 : 1994 | Identical |
| BS EN 550:1994 | Identical |
| NS EN 550 : 1ED 1994 | Identical |
| UNE-EN 550:1995 | Identical |
| DIN EN 550:1994-11 | Identical |
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