SS-EN-ISO-11135-AM1 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)

SS-EN-ISO-11135-AM1 - 2014 EDITION AMENDMENT 1 - CURRENT


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ISO 11135:2014 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.

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Active implantable medical devices. Medical devices. In vitro diagnostic medical devices

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Designation Name

SS-EN ISO 11135:2014/A1:2019

Revision Level

2014 EDITION AMENDMENT 1

Status

Current

Publication Date

Nov. 28, 2019

Language(s)

English

Page Count

28

International Equivalent

EN ISO 11135:2014/A1:2019(IDT); ISO 11135:2014/Amd 1:2018(IDT)