I.S. EN 13060:2014+A1:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Small steam sterilizers
Hardcopy , PDF
24-01-2020
English
25-11-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
European 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 (see 3.18 and 3.30)
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) Example of a process challenge device for narrow lumen
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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