Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_11
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 11
Character Range: 30475–32600

11                                                                                                                                                            both of the following:                                                                                                                                                                                                                                                                               for use in the validation and routine control of terminally sterilized 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 11607-1:2019 Packaging for terminally sterilized medical devicesPart 1: Requirements for materials, sterile barrier systems and packaging systems; 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 11607-2:2019 Packaging for terminally sterilized medical devicesPart 2: Validation requirements for forming, sealing and assembly processes