UNI EN 554 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
11-01-2007
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.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.