PREN 1422 : DRAFT 2011

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 equipment
Annex B (normative) - Tests for gas tightness
        of the sterilizer chamber
Annex C (normative) - Sterilizer chamber temperature
        profile test
Annex D (normative) - Sound power test
Annex E (normative) - Microbiological test for ethylene
        oxide sterilizers
Annex F (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

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