M00000813
New product
ISO TS 13004 1st Edition, May 1, 2013 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
In stock
Warning: Last items in stock!
Availability date: 07/13/2021
Description / Abstract:
This Technical Specification 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. This Technical Specification also specifies a
method of sterilization dose audit used to demonstrate the
continued effectiveness of the substantiated sterilization
dose.
NOTE Selection and substantiation of the sterilization dose is
used to meet the requirements for establishing the sterilizing does
within process definition in ISO 11137-1
Exclusions
This method is for the substantiation of a selected
sterilization does of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy only
and is not used oto substantiate other sterilization doses. The
method is not used for the substantiation of a selected
sterilization does if the average bioburden of the entire product
item exceeds the limit specified for the selected for the selected
sterilization does.
NOTE The methods for subst antiation of selected sterilization
doses of 25 kGy and 15 kGy are not included in this Technical
Specification; they are described in ISO 11137-2.
Application
If the decision is made to use this method of sterilization does
establishment, the method is to be followed according to the
requirements (shall) and guidance (should) stipulated herein.