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) |