Federal Register of Legislation - Australian Government

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MDSO No. 2 Orders/Other as made
This Order relates to the medical device standard for risk management.
Administered by: Health
Registered 10 Apr 2007
Tabling HistoryDate
Tabled HR18-Mar-2003
Tabled Senate19-Mar-2003
Gazetted 05 Mar 2003
Date of repeal 29 May 2008
Repealed by Medical Device Standards Order (Standards for Risk Management) 2008

COMMONWEALTH OF AUSTRALIA

 

Therapeutic Goods Act 1989

 

MEDICAL DEVICE STANDARDS ORDER NO. 2

 

Medical Device Standards for Risk Management

 

 

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 the Schedule constitute a medical device standard for all kinds of medical devices, subject to the conditions (if any) set out in column 3 of that item of the Schedule, and

 

(b)          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 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

Item No.

2

Medical Device Standard

3

Conditions

4

Essential Principle

1

AS/NZS 4810.1:2000

Medical devices - Risk management – Application of risk analysis
clauses 1 to 9 inclusive

 

OR

 

EN ISO 14971:2002

identical to:

ISO  14971:2000

Medical Devices – Application of Risk Management to Medical Devices

Clauses 1 to 9 inclusive

Provides a method to identify the risk associated with the use of the device but not the specific means to implement the reduction of risks.

1 (b)

2 (2)