NEN EN ISO 11135 : 2014
Current
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Amended by
Published date
12-01-2013
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Defines requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
| DevelopmentNote |
Supersedes NEN EN ISO 11135-1 and NEN NPR CEN ISO/TS 11135-2. (07/2014) NEW CHILD AMD 1 2019 IS ADDED
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| DocumentType |
Standard
|
| ProductNote |
NEW CHILD AMD 1 2019 IS ADDED
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| PublisherName |
Netherlands Standards
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| EN ISO 11135:2014 | Identical |
| ISO 11135:2014 | Identical |
| PREN ISO 11135 : DRAFT 2011 | Identical |
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