AAMI TIR76 pdf free download

AAMI TIR76 pdf free download.Sterilization of health care products—Radiation— Substantiation of a selected sterilization dose at a specifed sterility assurance level: Method VD max SD-S.
4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing Requirements and guidance on definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing are given in ANSI/AAMI/ISO 11137-2:2013/(R)2019 and AAMI TIR35 [9]. 5 Selection and testing of product for substantiating and auditing a selected sterilization dose Requirements and guidance on selection and testing of product for substantiating and auditing a selected sterilization dose are given in ANSI/AAMI/ISO 11137-2:2013/(R)2019. 6 Method VD max SD-S —Substantiation of a selected sterilization dose at a specified sterility assurance level 6.1 Rationale Operationally, the method of substantiation for a selected sterilization dose is similar to dose setting Method 1 of ANSI/AAMI/ISO 11137-2:2013/(R)2019; it too requires a determination of bioburden and the performance of a verification dose experiment.In carrying out substantiation, the method verifies that bioburden present on product prior to sterilization is less resistant to radiation than a microbial population of maximal resistance consistent with the attainment of a selected SAL at the selected sterilization dose; verification is conducted through performance of a verification dose experiment using 10, 30, or 90 product items. The dose at a verification SAL for a population having this resistance (maximal verification dose, VD max ) is characteristic of the bioburden level, the sterilization dose, and the associated maximal resistance. In establishing the maximal resistance for a particular bioburden level and sterilization dose, due account has been taken of the various resistance components of the SDR. Components of the SDR of high resistance that have significant effect on the attainment of the sterilization SAL have been used to define the maximal resistances on which this substantiation method is based. In this way, the level of conservativeness of the SDR, and thus of Method 1, is preserved. See Kowalski and Tallentire (1999) [2]; Kowalski, Aoshuang, and Tallentire (2000) [3]; Kowalski and Tallentire (2003) [5]. In practice, a determination is made of the average bioburden. The VD max SD-S dose corresponding to the selected sterilization dose, average bioburden, SIP, and selected SAL is calculated by the Method VD max SD-S CT; it is the dose at which the verification dose experiment is carried out. The product items (10, 30, or 90), or portions thereof, are exposed to the VD max SD-S dose and each item is subjected individually to a test of sterility. If there are no more than two positive tests of sterility in the tests carried out, the pre-selected sterilization dose is substantiated. NOTE 1 The acceptance criterion of no more than two positive tests of sterility differs from that for Method VD max SD in ANSI/AAMI/ISO 11137-2 and ANSI/AAMI/ISO TIR13004 [1]; a confirmatory verification dose experiment is not required for two positive tests of sterility. See Annex A and Kowalski (2019) [10].6.2.2 Factors for consideration in selecting a sterilization dose A key factor that should be considered when selecting the sterilization dose that is entered in Line E of the Calculations Inputs – Part 2 Panel of the CT (see 6.3.5.1 and 6.4.5.1) is the average bioburden and its relationship to the upper limit associated with the selected sterilization dose and SAL. For reference, Annex D gives tabulations of approximate upper limit average bioburden values for sets of selected sterilization doses; tables are given for 10 -6 , 10 -5 , 10 -4 , and 10 -3 SAL values.AAMI TIR76  pdf download.