DIN EN ISO 11135:2014-10
Withdrawn
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
Hardcopy , PDF
German, English
10-01-2014
01-30-2021
This International Standard specifies 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.
| Committee |
TC 198
|
| DevelopmentNote |
Supersedes DIN EN ISO 11135-1 & DIN ISO/TS 11135-2. (10/2014) DRAFT AMD 1 issued in September 2017. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
92
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11135:2014 | Identical |
| ISO 11135:2014 | Identical |
| I.S. EN ISO 11135:2014 | Equivalent |
| BS EN ISO 11135:2014 | Equivalent |
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