NBN EN 554 : 1995

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.