I, LARRY KELLY, delegate of the Minister for Health and Ageing for the purposes of section 41CB of the Therapeutic Goods Act 1989 and acting under that section, hereby:
This Order commences on the day after it is registered in the Federal Register of Legislative Instruments.
| 1 Item No. | 2 Medical Device Standard | 3 Conditions | 4 Essential Principle |
| 1 | AS EN 556-1: 2002 OR EN 556-1: 2001 Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices (Note: AS EN 556-1: 2002 is identical to EN 556-1: 2001) AND EN ISO 11607-1: 2006 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. AND EN ISO 11607-2: 2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes. | | Schedule 1, subclause 8.3(2) |
| 2 | EN 556-2: 2003 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices | | Schedule 1, subclause 8.3(2) |
| 3 | EN ISO 11135-1: 2007 Sterilization of health care products – Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. | For use in the validation and routine control of ethylene oxide sterilization processes for medical devices. | Schedule 1, subclause 8.3(3) |
| 4 | AS/NZS ISO 11137-1: 2006 OR ISO 11137-1: 2006 Sterilization of health care products – Radiation - Part 1: Requirements for validation and routine control – Radiation sterilization. AND AS/NZS ISO 11137-2: 2006 OR ISO 11137-2: 2006 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. AND AS/NZS ISO 11137-3: 2006 OR ISO 11137-3: 2006 Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects. (Note: AS/NZS ISO 11137: 2006 series is identical to ISO 11137: 2006 series.) | For use in the validation and routine control of radiation sterilization processes for medical devices. | Schedule 1 subclause 8.3(3) |
| 5 | EN ISO 17665-1: 2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | For use in the validation and routine control of steam sterilization processes, together with microbiological validation demonstrating compliance with AS EN 556-1: 2002. | Schedule 1 subclause 8.3(3) |
| 6 | AS ISO 14160: 2002 OR ISO 14160: 1998 Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants (Note: AS ISO 14160: 2002 and ISO 14160: 1998 are identical) | For use in the validation and routine control of sterilization by liquid chemical sterilants for medical devices. | Schedule 1 subclause 8.3(3) |
| 7 | ISO 11737-1: 2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products, including Technical Corrigendum 1: 2007 | For use in the bioburden determination of medical devices for all sterilization processes for medical devices. | Schedule 1 subclause 8.3(3) |
| 8 | ISO 11737-2: 1998 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process | For use in the tests of sterility performed in the validation of sterilization processes for medical devices. | Schedule 1 subclause 8.3(3) |
| 9 | ISO 13408-1: 2008 Aseptic processing of health care products – Part 1: General requirements. OR ISO 13408-1: 1998 Aseptic processing of health care products – Part 1: General requirements. OR EN 13824: 2004 Sterilization of medical devices: Aseptic processing of liquid medical devices – Requirements. AND ISO 13408-2: 2003 Aseptic processing of health care products – Part 2: Filtration. AND ISO 13408-3: 2006 Aseptic processing of health care products – Part 3: Lyophilization. AND ISO 13408-4: 2005 Aseptic processing of health care products – Part 4: Clean-in-place technologies. AND ISO 13408-5: 2006 Aseptic processing of health care products – Part 5: Sterilization in place. AND ISO 13408-6: 2005 Aseptic processing of health care products – Part 6: Isolator systems | For use in the validation and routine control of aseptic manufacturing processes for medical devices that are not terminally sterilized, together with the applicable Part(s) 2, 3, 4, 5, 6 of ISO 13408 as set out in column 2. ISO 13408-1: 1998 and EN 13824: 2004 will not constitute a medical devices standard, for all kinds of medical devices that have been manufactured using an aseptic process, after 30 September 2009 | Schedule 1 subclause 8.3(3) |
| 10 | ISO 14937: 2000 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, including Technical Corrigendum 1: 2003 | For use in the validation and routine control of a sterilization process for medical devices that is not covered by the standards specified in Items 3, 4, 5 and 6 of this Schedule. | Schedule 1, subclause 8.3(3) |
| 11 | EN ISO 17664: 2004 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices | For use in circumstances where the manufacturer intends that a medical device is suitable to be resterilized | Schedule 1, clause 13.4 items 12 or 13 |
| 12 | TGA Guidelines for sterility testing of therapeutic goods – 2006 as published on the TGA web-site at: http://www.tga.gov.au/docs/html/ sterilit.htm | To be used when an end-point sterility test is required to support product release. | Schedule 1, subclause 8.3(3) |