PD CEN ISO/TS 13004:2014

What is ISO/TS 13004 - VDmaxSD for substantiation of selected sterilization dose about?  

ISO/TS 13004 is a European standard that discusses the sterilization of health care products. ISO/TS 13004 outlines 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 outlines 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 are used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1. 

Who is ISO/TS 13004 - VDmaxSD for substantiation of selected sterilization dose for? 

ISO/TS 13004 on  VDmaxSD for substantiation of selected sterilization dose is useful for:  

• Medical laboratories 
• Regulatory authorities 

Why should you use ISO/TS 13004 - VDmaxSD for substantiation of selected sterilization dose? 

Method VDmax is a procedure for sterilization dose substantiation that uses the maximal verification dose for a given bioburden, consistent with the attainment of a SAL of 10−6 at a selected sterilization dose. VDmaxSD is a maximal verification dose for a particular selected sterilization dose (SD) obtained in using Method VDmaxSD bioburden, consistent with the attainment of a SAL of 10−6 at a selected sterilization dose. 

ISO/TS 13004 guideline assists you with the maintenance of product families for sterilization dose substantiation and sterilization dose auditing. ISO/TS 13004 assists you in the selection and testing of the product for substantiating and auditing a selected sterilization dose. ISO/TS 13004 provides method VD max SD for Substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5, or 35 kGy.

ISO/TS 13004 also provides guidelines on maintaining process effectiveness. 

ISO/TS 13004 also provides Tables of values for SIP equal to 1,0 VDmaxSD, SIP dose reduction factor, and augmentation dose corresponding to applicable values of average bioburden for selected sterilization doses of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy. 

With compliance and obedience to ISO/TS 13004, you can efficiently assess products substantiation of selected sterilization dose to obtain results that are reliable and comparable to other laboratories.