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
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 is an Order made by the delegate of the Minister for health and Ageing under section 41 DC of the Therapeutic Goods Act 1989 that revokes and replaces Conformity Assessment Standards Order No. 1 of 2003 that was made on 20 February 2003 and gazetted on 5 March 2003.
The Order (CASO 1 of 2005) introduces new conformity assessment standards for quality management systems for the manufacture of medical devices that require conformity assessment. The new standards are based on Australian standard AS ISO 13485-2003 Medical Devices - Quality management systems - Requirements for regulatory purposes, which is identical to ISO 13485:2003 Medical Devices - Quality management systems - Requirements for regulatory purposes. The Order also makes the condition that certain standards will no longer apply after 31 July 2006.
CASO 1 of 2005 was registered on the Federal Register of Legislative Instruments (FRLI) on 28 September 2005 (FRLI reference no. F2005L02892) and came into effect on the day after it was registered.
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:
- REVOKE "Conformity Assessment Standards Order No. 1 - Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques" made on 20 February 2003, and
- DETERMINE:
- 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
- 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
- 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 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 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 |
| 2 |
AS ISO 13485-2003 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 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 |
| 3 |
AS ISO 13485-2003 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 OR AS ISO 13488: 2002 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 OR EN 550: 1994 |
For the validation of ethylene oxide sterilisation procedures. |
Schedule 3 AND Schedule 3 |
| 2 |
AS ISO 11137-2002 OR EN 552: 1994 |
For the validation of radiation sterilisation procedures. |
Schedule 3 AND Schedule 3 |
| 3 |
ISO 11134: 1994 OR AS EN 554: 2002 |
For the validation of steam sterilisation procedures. |
Schedule 3 AND Schedule 3 |
| 4 |
AS ISO 14160-2002 |
For the validation of sterilisation procedures using liquid chemical sterilants. |
Schedule 3 AND Schedule 3 |