Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing
DIN EN 14180:2010-01 (E)
Sterilizers for medical purposes – Low temperature steam and formaldehyde
sterilizers – Requirements and testing (includes Amendment A2:2009)
Contents Page
age Foreword …………………………………………………………………………………………………………………………………3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..4
2 Normative references ……………………………………………………………………………………………………..4
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Technical requirements …………………………………………………………………………………………………10
5 Process control …………………………………………………………………………………………………………….19
6 Performance requirements ……………………………………………………………………………………………22
7 Sound power …………………………………………………………………………………………………………………23
8 Marking and labelling …………………………………………………………………………………………………….24
9 Information to be supplied by the manufacturer …………………………………………………………….24
10 Service and local environment ………………………………………………………………………………………26
Annex A (normative) Test methods ……………………………………………………………………………………………….29
Annex B (normative) Sterilizer classification and testing ……………………………………………………………….34
Annex C (normative) Test equipment …………………………………………………………………………………………….37
Annex D (normative) Determination of formaldehyde residuals in a filter indicator ………………………..40
Annex E (informative) Formaldehyde residues on medical devices ……………………………………………….43
Annex F (informative) Environmental aspects ……………………………………………………………………………….45
Annex ZA (informative) !!!!Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC”””” …………………………………………………………………48
Bibliography …………………………………………………………………………………………………………………………………51