Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_3
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 3
Character Range: 13972–17778

3                                                                                                                                                             all of the following:                                                                                                                                                                                                                                                                                for use in the validation and routine control of aseptic manufacturing processes for medical devices that are not terminally sterilized, including sterilizing filtration, lyophilisation, clean-in-place technologies, sterilization in place, isolator systems and alternative processes for medical devices and combination products     (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 13408-1:2008 Aseptic processing of health care productsPart 1: General requirements; 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 13408-1:2008/ Amd 1:2013; and
                                                                                                                                                                 (c) ISO 13408-2:2018 Aseptic processing of health care productsPart 2: Sterilizing filtration; and
                                                                                                                                                                 (d) ISO 13408-3:2006 Aseptic processing of health care productsPart 3: Lyophilization; and
                                                                                                                                                                 (e) ISO 13408-4:2005 Aseptic processing of health care productsPart 4: Clean-in-place technologies; and
                                                                                                                                                                 (f) ISO 13408-5:2006 Aseptic processing of health care productsPart 5: Sterilization in place; and
                                                                                                                                                                 (g) ISO 13408-6:2005 Aseptic processing of health care productsPart 6: Isolator systems; and
                                                                                                                                                                 (h) ISO 13408-6:2005/Amd 1:2013; and
                                                                                                                                                                 (i) ISO 13408-7:2012 Aseptic processing of health care productsPart 7: Alternative processes for medical devices and combination products