COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

CONFORMITY ASSESSMENT STANDARDS ORDER (STANDARD FOR QUALITY MANAGEMENT SYSTEMS AND QUALITY ASSURANCE TECHNIQUES) 2008

I, LARRY KELLY, 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 21 September 2005; AND

(2) DETERMINE:

(a) that the matters specified in the relevant standards or in the relevant parts of a standard published by a standards organisation 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 the relevant standards or in the relevant parts of a standard published by a standards organisation 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) that 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 set out in the Therapeutic Goods (Medical Devices) Regulations 2002 that are specified in column 4 of the relevant item of the respective Schedules.

This Order commences on the day after it is registered in the Federal Register of Legislative Instruments.

Dated this 14th day of November 2008

Signed

Larry Kelly

Delegate of the Minister for Health and Ageing

SCHEDULE 1

Item No.

Conformity Assessment Standard

Conditions

Conformity Assessment Procedure

AS ISO 13485: 2003

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.

(Note: AS ISO 13485: 2003 is identical to ISO 13485: 2003)

Schedule 3

Part 1, clause 1.4

AS ISO 13485: 2003

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.

(Note: AS ISO 13485: 2003 is identical to ISO 13485: 2003)

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 OR 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. (Note: AS ISO 13485: 2003 is identical to ISO 13485: 2003)		Schedule 3 Part 5, clause 5.4

Item No.

Conformity Assessment Standard

Conditions

Conformity Assessment Procedure

AS ISO 13485: 2003

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.

(Note: AS ISO 13485: 2003 is identical to ISO 13485: 2003)

Schedule 3

Part 5,

clause 5.4

SCHEDULE 2

1 Item No.	2 Conformity Assessment Standard	3 Conditions	4 Conformity Assessment Procedure
1	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 3 Part 1, subparagraph 1.4(5)(d)(i) AND Schedule 3 Part 4, subparagraph 4.4(5)(c)(i)
2	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 3 Part 1, subparagraph 1.4(5)(d)(i) AND Schedule 3 Part 4, subparagraph 4.4(5)(c)(i)
3	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	Schedule 3 Part 1, subparagraph 1.4(5)(d)(i) AND Schedule 3 Part 4, subparagraph 4.4(5)(c)(i)
4	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 processes for medical devices using liquid chemical sterilants.	Schedule 3 Part 1, subparagraph 1.4(5)(d)(i) AND Schedule 3 Part 4, subparagraph 4.4(5)(c)(i)
5	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 conformity assessment standard for the aseptic manufacturing processes of all kinds of medical devices after 30 September 2009.	Schedule 3 Part 1, subparagraph 1.4(5)(d)(i) AND Schedule 3 Part 4, subparagraph 4.4(5)(c)(i)
6	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 1, 2, 3 and 4 of this schedule.	Schedule 3 Part 1, subparagraph 1.4(5)(d)(i) AND Schedule 3 Part 4, subparagraph 4.4(5)(c)(i)

Item No.

Conformity Assessment Standard

Conditions

Conformity Assessment Procedure

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 3

Part 1, subparagraph

1.4(5)(d)(i)

AND

Schedule 3

Part 4, subparagraph

4.4(5)(c)(i)

AS/NZS ISO 11137-1: 2006

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

ISO 11137-2: 2006 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.

AND

AS/NZS ISO 11137-3: 2006

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 3

Part 1, subparagraph

1.4(5)(d)(i)

AND

Schedule 3

Part 4,

subparagraph

4.4(5)(c)(i)

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

Schedule 3

Part 1, subparagraph

1.4(5)(d)(i)

AND

Schedule 3

Part 4,

subparagraph

4.4(5)(c)(i)

AS ISO 14160: 2002

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 processes for medical devices using liquid chemical sterilants.

Schedule 3

Part 1, subparagraph

1.4(5)(d)(i)

AND

Schedule 3

Part 4, subparagraph

4.4(5)(c)(i)

ISO 13408-1: 2008 Aseptic processing of health care products – Part 1: General requirements.

ISO 13408-1: 1998 Aseptic processing of health care products – Part 1: General requirements.

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 conformity assessment standard for the aseptic manufacturing processes of all kinds of medical devices after 30 September 2009.

Schedule 3

Part 1,

subparagraph

1.4(5)(d)(i)

AND

Schedule 3

Part 4,

subparagraph

4.4(5)(c)(i)

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 1, 2, 3 and 4 of this schedule.

Schedule 3

Part 1, subparagraph

1.4(5)(d)(i)

AND

Schedule 3

Part 4, subparagraph

4.4(5)(c)(i)