I.S. EN 554:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
Hardcopy , PDF
04-10-2006
English
01-01-1994
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.
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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Superseded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 |
| UNE-EN 554:1995 | Identical |
| NF EN 554 : 1994 | Identical |
| NS EN 554 : 1994 | Identical |
| UNI EN 554 : 1996 | Identical |
| NBN EN 554 : 1995 | Identical |
| EN 554 : 1994 | Identical |
| NEN EN 554 : 1994 | Identical |
| SN EN 554 : 1995 | Identical |
| BS EN 554:1994 | Identical |
| DIN EN 554:1994-11 | Identical |
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