Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_4
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 4
Character Range: 17778–19591

4                                                                                                                                                             ISO 14160:2011 Sterilization of health care productsLiquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivativesRequirements for characterization, development, validation and routine control of a sterilization process for medical devices  for use in the validation and routine control of sterilization processes for medical devices using liquid chemical sterilants                                                                                                                                                                                                               (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               (b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations