EN
SR EN ISO 11137-2:2012
Sterilizarea dispozitivelor pentru îngrijirea sănătăţii. Iradiere. Partea 2: Stabilirea dozei de sterilizare
ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Status :
Anulat
Data aprobării : 31.08.2012
Data anulării : 29.11.2013
Număr de pagini : 85
ICS : 13.140 Zgomot si efectele sale asupra omului
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 11137-2:2007/AC:2009
- Inlocuieste SR EN ISO 11137-2:2007
- Inlocuit prin SR EN ISO 11137-2:2013