NF 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
01-11-2017
12-01-2013
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. Does not describe a quality assurance system for the control of all stages of manufacture. Also gives definitions and annexes.
| DevelopmentNote |
INDICE DE CLASSEMENT: S98105
|
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| I.S. EN 554:1994 | Identical |
| UNE-EN 554:1995 | Identical |
| DIN EN 554:1994-11 | Identical |
| BS EN 554:1994 | Identical |
| EN 554 : 1994 | Identical |
| FD S98 135 : 2005 FD | STERILISATION OF MEDICAL DEVICES - GUIDELINES FOR THE CONTROL OF THE TREATMENTS APPLIED TO THE RE-USABLE MEDICAL DEVICES |
| XP S94 091 : 2008 XP | IMPLANTS FOR SURGERY - VALIDATION OF THE CLEANING OF ORTHOPAEDIC IMPLANTS BEFORE FINAL CONDITIONING |
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