DIN EN 1422:1997-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-11-1997
07-03-2021
National foreword
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 instrumentation
Annex B (normative) - Leak test cycle
Annex C (normative) - Sterilizer chamber
profile testing
Annex D (normative) - Microbiological test for
EO sterilizers
Annex E (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
Defines the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| BS EN 1422:2014 | Identical |
| NBN EN 1422 : 2014 | Identical |
| EN 1422:2014 | Identical |
| NF EN 1422 : 2014 | Identical |
| NS EN 1422 : 2014 | Identical |
| I.S. EN 1422:2014 | Identical |
| NEN EN 1422 : 2014 | Identical |
| BS EN 1422 : 1997 | Equivalent |
| EN 1422:1997+A1:2009 | Equivalent |
| I.S. EN 1422:1997+A1:2009 | Equivalent |
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