I.S. EN 554:1994
Superseded
View Superseded by
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
Hardcopy , PDF
English
01-01-1994
10-04-2006
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. (informative) Guidance on the application of EN 554
B. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references
Specifies requirements for the process development, validation, process control and monitoring of the sterilisation of medical devices using moist heat.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 554 : 1994 | Identical |
| NS EN 554 : 1994 | Identical |
| NBN EN 554 : 1995 | Identical |
| EN 554 : 1994 | Identical |
| NEN EN 554 : 1994 | Identical |
| BS EN 554:1994 | Identical |
| UNE-EN 554:1995 | Identical |
| DIN EN 554:1994-11 | Identical |
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