ISO 11137-2:2006

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

Datum objavljivanja: 19. 4. 2006.

95.99 Povučen 15. 3. 2012.

Опште информације

Trenutna faza: 95.99 Effective date: 15. 3. 2012.

Inicijator: ISO

Pripada: ISO/TC 198

Vrsta: Međunarodni standard

ICS: 11.080.01

Jezik: engleski francuski

Kupovina

Status: Povučen

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Apstrakt

ISO 11137-2:2006 specifies methods of 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.