30.00 4. 8. 2025.
ISO
ISO/TC 198
Međunarodni standard
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.
PROJEKAT
ISO/CD 11137-2
30.00
Evidentiranje nacrta komisije standarda
4. 8. 2025.
Sterilizacija proizvoda za zaštitu zdravlja – Zračenje – Deo 2: Utvrđivanje doze sterilizacije – Izmena 1
10.99 Novi projekat se prihvata