I.S. EN 13060:2014+A1:2018&LC:2018
Current
The latest, up-to-date edition.
Small steam sterilizers
Hardcopy , PDF
English
18-12-2018
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.
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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
This European Standard specifies 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.
| Committee |
CEN/TC 102
|
| DocumentType |
Test Method
|
| Pages |
92
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO prEN ISO 11140-6
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 13060:2014+A1:2018 | Identical |
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