Federal Register of Legislation - Australian Government

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MDSO No. 3 Orders/Other as made
This Order relates to the medical device standard for medical devices required to be sterile.
Administered by: Health
Registered 10 Apr 2007
Tabling HistoryDate
Tabled HR18-Mar-2003
Tabled Senate19-Mar-2003
Gazetted 05 Mar 2003
Date of repeal 22 Nov 2008
Repealed by Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008

COMMONWEALTH OF AUSTRALIA

 

Therapeutic Goods Act 1989

 

MEDICAL DEVICE STANDARDS ORDER NO. 3

 

Medical Device Standards for Medical Devices Required to be Sterile

 

 

I, RITA MACLACHLAN, 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, DETERMINE:

 

(a)           that the matters specified in column 2 of an item in Schedule 1 constitute a medical device standard for 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 the Schedule 1, and

 

(b)          that the matters specified in column 2 of an item in the Schedule 2 constitute a medical device standard for kinds of medical devices that are intended by the manufacturer to be sterilised before they are used, subject to the conditions (if any) set out in column 3 of that item of  Schedule 2, and

 

(c)           medical devices of those kinds that comply with the standard are to be treated as complying with those parts of the essential principles specified in column 4 of the relevant item of the relevant Schedule.

 

This Order commences on the day it is gazetted in the Commonwealth Gazette.

 

Dated this                     twentieth          day of                      February          2003

 

 

 

 

 

Rita Maclachlan

Delegate of the Minister for Health and Ageing


 

Schedule 1

 

1

Item No.

2

Medical Device Standard

3

Conditions

4

Essential Principle

1

 

AS EN 556.1-2002

identical to:

EN 556-1: 2001

Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices

 

AND EITHER

 

EN 868-1: 1997

Packaging materials and systems for medical devices which are to be sterilized – Part 1:general requirements and test methods

 

OR

 

ISO 11607: 1997

Packaging for terminally sterilized medical devices

 

8.3(2)

2

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.

8.3(3)


 

1

Item No.

2

Medical Device Standard

3

Conditions

4

Essential Principle

3

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.

8.3(3)

4

ISO 11134: 1994

Sterilization of health care products – Requirements for validation and routine control – Industrial moist heat sterilization

 

OR

 

EN 554: 1994

Sterilization of medical devices – Validation and routine control of sterilization by moist heat

To be used for the validation of steam sterilisation procedures, together with microbiological validation demonstrating compliance with AS EN 556.1- 2002.

8.3(3)

5

AS ISO 14160-2002

identical to:

EN ISO 14160: 1998

identical to:

ISO 14160: 1998

Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants

To be used for the validation of sterilisation by liquid chemical sterilants

8.3(3)

6

TGA Guidelines for sterility testing of Therapeutic Goods – 2002

To be used when an end-point sterility test is required to support product release.

 

8.3(3)

 


 

Schedule 2

 

1

Item No.

2

Medical Device Standard

3

Conditions

4

Essential Principle

1

EN 868-1: 1997

Packaging materials and systems for medical devices which are to be sterilized – Part 1:general requirements and test methods

 

OR

 

ISO 11607: 1997

Packaging for terminally sterilized medical devices

 

8.4(2)