NEN EN 13060 : 2014
Current
The latest, up-to-date edition.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) Clarification of the definition of
hollow space A and hollow space B
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 ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42 EEC on medical
devices
Bibliography
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