NEN EN 1422 : 2014
Current
The latest, up-to-date edition.
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations
5 Size
6 Vessels, materials and construction
7 Components, pipework and fittings
8 Doors, controls and interlocks
9 Control valves
10 Services
11 Sound power
12 Thermal insulation
13 Electromagnetic interference
14 Instruments and controls
15 Sterilization cycle
16 Performance requirements
17 Information to be supplied by the manufacturer
18 Marking
19 Safety
20 Storage and transport
Annex A (informative) Suggested maximum values of steam
contaminants
Annex B (normative) Steam quality tests
Annex C (normative) Chamber temperature profile tests
Annex D (normative) Sound power test
Annex E (normative) Tests for gas tightness of the
sterilizer chamber
Annex F (normative) Biological performance type test for
Type B ethylene oxide sterilizers
Annex G (normative) Temperature recording equipment for
test purposes
Annex H (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives
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