DIN EN 1422:1997-11

National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power
8 Packaging, marking and labelling
9 Information to be supplied by the
   manufacturer
10 Service and local environment
Annex A (normative) - Test instrumentation
Annex B (normative) - Leak test cycle
Annex C (normative) - Sterilizer chamber
        profile testing
Annex D (normative) - Microbiological test for
        EO sterilizers
Annex E (informative) - Environmental aspects
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices
Bibliography

Defines the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.