DIN EN ISO 11135:2020-04
Current
The latest, up-to-date edition.
Sterilization of healthcare products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); English version EN ISO 11135:2014 + A1:2019, English translation of DIN EN ISO 11135:2020-04
Hardcopy , PDF
English
04-01-2020
Important note : All end users must be registered with an Account prior to user licenses being assigned.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
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11135:2014/Amd 1:2018 | Identical |
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