prEN ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137‑2:2026)
Draft Public enquiryProject stage codes
1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2026-08-16
till 2026-10-15
4. Closure of enquiry
5. Submission to Formal Vote
Organisation
CEN Europos standartizacijos komitetasICS
11.080.01 - Sterilization and disinfection in generalTechnical Committee
TK 32 HealthForeignTC'S
CEN/TC 204Number of comments
0Comment start date
2026-08-16Scope
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.Relations
Pakeis
LST EN ISO 11137-2:2015/A1:2023
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/FDAM 1:2022)
Pakeis