SR EN ISO 11135:2014/A1:2020

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

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General information

Status : Valid
Approval date : 3/31/2020
Number of pages : 24
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Amends SR EN ISO 11135:2014