EN 13060:2004+A2:2010: Small steam sterilizers
DIN EN 13060:2010-06 (E)
Small steam sterilizers (includes Amendment A2:2010)
Contents Page
page Foreword ……………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General technical requirements …………………………………………………………………………………….13
5 Performance requirements ……………………………………………………………………………………………28
6 Safety ……………………………………………………………………………………………………………………………30
7 Categories of tests ………………………………………………………………………………………………………..30
8 Test equipment ……………………………………………………………………………………………………………..32
9 Test programme ……………………………………………………………………………………………………………40
10 Test methods ………………………………………………………………………………………………………………..41
Annex A (informative) Clarification of the definition of hollow space A and hollow space B (see
3.19 and 3.20) ………………………………………………………………………………………………………………..57
Annex B (informative) Process evaluation system …………………………………………………………………………59
Annex C (informative) Suggested maximum limits of contaminants in and specification for water
for steam sterilization ……………………………………………………………………………………………………60
Annex D (informative) Example of a table to be supplied with pre-purchase documentation and
with the instructions for use ………………………………………………………………………………………….61
Annex E (informative) Load support systems ………………………………………………………………………………..62
Annex F (informative) Rationale for the tests …………………………………………………………………………………63
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC on medical devices …………………………………………65
Bibliography …………………………………………………………………………………………………………………………………68