I.S. EN 13060:2004+A2:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Small steam sterilizers
Hardcopy , PDF
28-01-2020
English
16-04-2010
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.
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 (see 3.19
And 3.20)
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
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 |
70
|
| ProductNote |
THIS STANDARD ALSO REFERS TO EN 285:1996,EN 61010-2-041:1996,EN 61326:1997,EN 764-1:2004,ISO/DIS 14538:1997,93/42/EEC:1993 THIS STANDARD IDENTICAL TO EN 13060:2004+A2:2010
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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