Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_10
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 10
Character Range: 28662–30475

10                                                                                                                                                            ISO 25424:2018 Sterilization of health care productsLow temperature steam and formaldehydeRequirements for development, validation and routine control of a sterilization process for medical devices                                                                                              for use in the validation and routine control of low temperature steam and formaldehyde sterilization processes                                                                                                                                                                                                                             (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