PREN 14180 : DRAFT 2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power and vibration
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test methods
Annex B (normative) - Sterilizer classification and testing
Annex C (normative) - Test equipment
Annex D (normative) - Determination of formaldehyde residuals
        in a filter indicator
Annex E (informative) - Formaldehyde residues on medical devices
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

Describes requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.