PREN 13060 : DRAFT 2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety, risk control and usability
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) - Clarification of the definition
        of narrow lumens and simple hollow items
Annex B (informative) - Process evaluation system
Annex C (informative) - Suggested maximum limits
        of contaminants in and specification for
        water for steam sterilization
Annex D (informative) - Example of a table to be
        supplied with pre-purchase documentation and
        with the instructions for use
Annex E (informative) - Load support systems
Annex F (informative) - Rationale for the tests
Annex G (informative)
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42 EEC
         on medical devices
Bibliography

Defines the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.