COMMONWEALTH OF AUSTRALIA

 

Therapeutic Goods Act 1989

 

MEDICAL DEVICE STANDARDS ORDER NO. 1

 

 

 

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


 

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)