COMMONWEALTH OF AUSTRALIA
Therapeutic Goods Act 1989
MEDICAL DEVICE STANDARDS ORDER NO. 1
Medical Device Standards for Clinical Evidence
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 item 1 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) the matters specified in column 2 of items 2 and 3 of the Schedule constitute a medical device standard for cardiac valve prosthesis and intraocular lenses respectively, and
(c) medical devices of those kinds that comply with the appropriate 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 EN 540-2002 identical to: EN 540: 1993 Clinical investigation of medical devices for human subjects
OR
AS ISO 14155-2002 identical to: ISO 14155:1996 Clinical investigation of medical devices |
| 14 |
2 | ISO 5840:1996 Cardiovascular implants – Cardiac valve prostheses clause 9
| Applicable to cardiac valve prosthesis only. | 1(a) |
3 | ISO 11979-7:2001 Ophthalmic implants – Intraocular lenses -- Part 7: Clinical investigations
| Applicable to intraocular lenses only. | 1(a) |