NEN EN 14180 : 2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
   4.1 Sterilizer chamber
   4.2 Design and construction
   4.3 Indicating, measuring, operating and recording devices
5 Process control
   5.1 General
   5.2 Sterilization cycle and automatic control
   5.3 Override of automatic control
   5.4 Fault
6 Performance requirements
   6.1 Sterilizing performance
   6.2 Desorption efficacy
   6.3 Drying
7 Sound power
8 Marking and labeling
9 Information to be supplied by the manufacturer
10 Service and local environment
   10.1 General
   10.2 Electricity
   10.3 Sterilant
   10.4 Steam
   10.5 Water
   10.6 Compressed air
   10.7 Drainage and discharges
   10.8 Ventilation and 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 indication
Annex E (informative) Formaldehyde residues on medical devices
Annex F (informative) Environmental aspects
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Defines 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.