ISO/TS 13004:2013
p
ISO/TS 13004:2013
52320

Abstract  Preview

ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.


General information 

  •  :  Published
     : 2013-05
  •  : 1
     : 57
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.01 Sterilization and disinfection in general

Buy this standard

en
Format Language
std 1 178 PDF + ePub
std 2 178 Paper
  • CHF178

Life cycle


Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.