Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_2
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 2
Character Range: 10395–13972

2                                                                                                                                                             all of the following:                                                                                                                                                                                                                                                                                for use in the validation and routine control of radiation sterilization processes for medical devices                                                                                                                                                                                                                                      (a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and
                                                                                                                                                                 (a) ISO 11137-1:2006 Sterilization of health care productsRadiation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         (b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations
                                                                                                                                                                 Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; and
                                                                                                                                                                 (b) ISO 11137-1:2006/Amd 1:2013; and
                                                                                                                                                                 (c) ISO 11137-1:2006/Amd 2:2018 Revision to 4.3.4 and 11.2; and
                                                                                                                                                                 (d) ISO 11137-2:2013 Sterilization of health care productsRadiationPart 2: Establishing the sterilization dose; and
                                                                                                                                                                 (e) ISO 11137-3:2017 Sterilization of health care productsRadiationPart 3: Guidance on dosimetric aspects of development, validation and routine control; and
                                                                                                                                                                 (f) ISO/TS 13004:2013 Sterilization of health care productsRadiation
                                                                                                                                                                 Substantiation of selected sterilization dose: Method VDmaxSD