ISO TS 13004:2013 pdf free

ISO TS 13004:2013 pdf free.Sterilization of health care products一Radiation
The establishment of a sterilization dose, for which sterilization dose selection and substantiation can be undertaken, and the carrying out of sterilization dose audits are activities that are part of process definition and maintaining process effectiveness (see ISO 11137-1). For these activities, product may be grouped into families; definition of product families is based principally on the numbers and types of microorganisms on or in product (the bioburden), the type being indicative of the microorganism’s resistance to radiation (see ISO 11737-1). Variables such as density and product configuration within its packaging system are not considered in the establishment of these product families because they are not factors that influence bioburden.
In using product families for establishing the sterilization dose and for carrying out sterilization dose audits, it is important to be aware of the reduction in the ability to detect an inadvertent change within the manufacturing process that influences the effectiveness of sterilization. Furthermore, with the use of a single product to represent the product family, changes that occur in other members of the product family might not be detected. The effect of a reduction on ability to detect changes in other members of the product family should be evaluated and a plan for maintaining product families developed and implemented before proceeding.
Product shall only be included in a product family if it is demonstrated that the product-related variables (see 4.2.1) are similar and under control.
To include product within a product family, it shall be demonstrated that bioburden comprises similar numbers and types of microorganisms.
Inclusion of product from more than one manufacturing location in a product family shall be specifically justified and recorded (see 4.1.2 of ISO 11137-1:2006). Consideration shall be given to the effect on bioburden of:
a) geographic and/or climatic differences between locations;
b) any differences in the control of the manufacturing processes or environment;
c) sources of raw materials and processing adjuvants (e.g. water).ISO TS 13004 pdf download.