Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_1
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 1
Character Range: 8349–10395

1                                                                                                                                                                both of the following:                                                                                                                                                                                                                                                                            for use in the validation and routine control of ethylene oxide 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 11135:2014 Sterilization of health-care productsEthylene oxideRequirements for the development, validation and routine control of a sterilization process for medical devices; and                                                                                                                                                                                                                                                                                                                                                                                                                                                  (b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations
                                                                                                                                                                 (b) ISO 11135:2014/Amd 1:2018 Revision of Annex E, Single batch release