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DIN EN ISO 11135:2020-04

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-01-2020

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
EN ISO 11135:2014/A1:2019 Identical
ISO 11135:2014/Amd 1:2018 Identical

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