Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_5
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 5
Character Range: 19591–21404

5                                                                                                                                                             ISO 14937:2009 Sterilization of health care productsGeneral requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices                                                                             for use in the validation and routine control of a sterilization process for medical devices that is not mentioned in any of the standards specified in items 1 to 4                                                                                                                                                                        (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