Therapeutic Goods Act 1989
CONFORMITY ASSESSMENT STANDARDS ORDER NO. 1 OF 2005
Replacement of Conformity Assessment Standards Order No. 1: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques made on 20 February 2003
I, RITA MACLACHLAN, delegate of the Minister for Health and Ageing for the purposes of section 41DC of the Therapeutic Goods Act 1989 and acting under that section, hereby:
(1) REVOKE “Conformity Assessment Standards Order No. 1 - Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques” made on 20 February 2003, and
(2) DETERMINE:
(a) that the matters specified in column 2 of an item in Schedule 1 constitute a conformity assessment standard for quality management systems for the manufacture of all kinds of medical devices that require conformity assessment, subject to the conditions (if any) set out in column 3 of that item of Schedule 1, and
(b) that the matters specified in column 2 of an item in Schedule 2 constitute a conformity assessment standard for quality assurance techniques for the manufacture of kinds of medical devices that are intended by the manufacturer to be supplied in a sterile state, subject to the conditions (if any) set out in column 3 of that item of Schedule 2, and
(c) quality management systems and quality assurance techniques of those kinds that comply with the standard are to be treated as complying with those parts of the conformity assessment procedures specified in column 4 of the relevant item of the respective Schedule.
This Order commences on the day after it is registered in the Federal Register of Legislative Instruments.
Dated this 21st day of September 2005
Rita Maclachlan
Delegate of the Minister for Health and Ageing
Schedule 1
| 1 Item No. | 2 Conformity Assessment Standard | 3 Conditions | 4 Conformity Assessment Procedure |
| 1 | AS ISO 13485-2003 identical to: ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes Any reference to regulatory requirements is a reference to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 OR AS ISO 13485: 2002 identical to: ISO 13485:1996 Quality systems – Medical devices – Particular requirements for the application of ISO 9001 This standard is amended as follows: Delete the NOTE in clause 4.2.1, and insert in its place: "The relevant requirements of the Therapeutic Goods (Medical Devices) Regulations 2002 shall be included in the specific requirements." | This standard will not constitute a conformity assessment standard for quality management systems for the manufacture of all kinds of medical devices after 31 July 2006. | Schedule 3 Part 1, clause 1.4 |
| 1 Item No. | 2 Conformity Assessment Standard | 3 Conditions | 4 Conformity Assessment Procedure |
| 2 | AS ISO 13485-2003 Identical to: ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes But excluding clause 7.3 - Design and Development Any reference to regulatory requirements is a reference to the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002 OR AS ISO 13488: 2002 identical to: ISO 13488:1996 Quality systems – Medical devices – Particular requirements for the application of ISO 9002 This standard is amended as follows: Delete the NOTE in clause 4.2.1, and insert in its place: "The relevant requirements of the Therapeutic Goods (Medical Devices) Regulations 2002 shall be included in the specific requirements." | This standard will not constitute a conformity assessment standard for quality management systems for the manufacture of all kinds of medical devices after 31 July 2006. | Schedule 3 Part 4, clause 4.4 |
Schedule 1
| 1 Item No. | 2 Conformity Assessment Standard | 3 Conditions | 4 Conformity Assessment Procedure |
| 3 | AS ISO 13485-2003 identical to: ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes But excluding clause 7.3 - Design and Development and clause 7.5.2 -Validation of processes for production and service provision Any reference to regulatory requirements is a reference to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 OR EN 46003: 1999 Quality systems – Medical devices – Particular requirements for the application of ISO 9003 OR AS ISO 13488: 2002 identical to: ISO 13488: 1996 Quality systems – Medical devices – Particular requirements for the application of ISO 9002 But excluding Clause 4.9 - Process Control AS ISO 13488: 2002 (& ISO 13488: 1996) is amended as follows: Delete the NOTE in clause 4.2.1, and insert in its place: "The relevant requirements of the Therapeutic Goods (Medical Devices) Regulations 2002 shall be included in the specific requirements." | This standard will not constitute a conformity assessment standard for quality management systems for the manufacture of all kinds of medical devices after 31 July 2006. | Schedule 3 Part 5, clause 5.4 |
Schedule 2
| 1 Item No. | 2 Conformity Assessment Standard | 3 Conditions | 4 Conformity Assessment Procedure |
| 1 | AS ISO 11135-2002 identical to: ISO 11135: 1995 Medical devices – Validation and routine control of ethylene oxide sterilization OR EN 550: 1994 Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization | For the validation of ethylene oxide sterilisation procedures. | Schedule 3 Part 1 – clause 1.4(5)(d)(i) AND Schedule 3 Part 4 – clause 4.4(5)(c)(i) |
| 2 | AS ISO 11137-2002 identical to: ISO 11137: 1995 Sterilization of health care products –Requirements for validation and routine control – Radiation sterilization OR EN 552: 1994 Sterilization of medical devices – Validation and routine control of sterilization by irradiation | For the validation of radiation sterilisation procedures. | Schedule 3 Part 1 – clause 1.4(5)(d)(i) AND Schedule 3 Part 4 – clause 4.4(5)(c)(i) |
| 3 | ISO 11134: 1994 Sterilization of health care products – Requirements for validation and routine control – Industrial moist heat sterilization OR AS EN 554: 2002 identical to: EN 554: 1994 Sterilization of medical devices – Validation and routine control of sterilization by moist heat | For the validation of steam sterilisation procedures. | Schedule 3 Part 1 – clause 1.4(5)(d)(i) AND Schedule 3 Part 4 – clause 4.4(5)(c)(i) |
Schedule 2
| 1 Item No. | 2 Conformity Assessment Standard | 3 Conditions | 4 Conformity Assessment Procedure |
| 4 | AS ISO 14160-2002 identical to: ISO 14160: 1998 identical to: EN ISO 14160: 1998 Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants | For the validation of sterilisation procedures using liquid chemical sterilants. | Schedule 3 Part 1 – clause 1.4(5)(d)(i) AND Schedule 3 Part 4 – clause 4.4(5)(c)(i) |