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prEN ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

Draft Public enquiry
Comment end date 2025-08-28
Export comments Read draft and comment

Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2025-06-29 till 2025-08-28
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 204

Number of comments

0

Comment start date

2025-06-29

Scope

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.

Relations

Pakeis
LST EN ISO 11135:2014/A1:2020
Pakeis
LST EN ISO 11135:2014