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BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
05-31-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test equipment
Annex B (normative) - Tests for gas tightness
of the sterilizer chamber
Annex C (normative) - Sterilizer chamber temperature
profile test
Annex D (normative) - Sound power test
Annex E (normative) - Microbiological test for ethylene
oxide sterilizers
Annex F (informative) - Environmental aspects
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
Bibliography
BS EN 1422.
| Committee |
LBI/35
|
| DocumentType |
Draft
|
| Pages |
50
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN 1422 : DRAFT 2011 | Identical |
A newer version of this standard is available.
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