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Glavni meni

ISO/CD 11137-2

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Опште информације

30.00     4. 8. 2025.

ISO

ISO/TC 198

Međunarodni standard

Apstrakt

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.

Životni ciklus

PRETHODNO

OBJAVLJEN
ISO 11137-2:2013

OBJAVLJEN
ISO 11137-2:2013/Amd 1:2022

TRENUTNO

PROJEKAT
ISO/CD 11137-2
30.00 Evidentiranje nacrta komisije standarda
4. 8. 2025.

Nacionalna preuzimanja

Sterilizacija proizvoda za zaštitu zdravlja – Zračenje – Deo 2: Utvrđivanje doze sterilizacije – Izmena 1

10.99   Novi projekat se prihvata