Federal Register of Legislation - Australian Government

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Orders/Other as made
This Order introduces standards (or parts of these standards) published by standards organisations that are relevant to biological safety of medical devices in order to demonstrate compliance with essential principle 7.1(b).
Administered by: Health
Registered 24 Nov 2008
Tabling HistoryDate
Tabled HR26-Nov-2008
Tabled Senate26-Nov-2008
Date of repeal 01 Apr 2019
Repealed by Sunsetting

COMMONWEALTH OF AUSTRALIA

 

Therapeutic Goods Act 1989

 

MEDICAL DEVICE STANDARDS ORDER (Standards for Biological Safety of Medical Devices) 2008

 

 

 

I, LARRY KELLY, 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 in the relevant standards that are specified in column 2 of an item in the Schedule constitute a medical device standard for the biological safety of a kind of medical device, subject to the conditions (if any) set out in column 3 of that item of the Schedule, and

 

(b)          that medical devices of those kinds that comply with the appropriate standard specified in column 2 are to be treated as complying with those parts of the essential principles set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 and that are specified in column 4 of the relevant item of the relevant Schedule.

 

This Order commences on the day after it is registered on the Federal Register of Legislative Instruments.

 

Dated this    14th      day of    November      2008

 

 

 

 

 

Larry Kelly

Delegate of the Minister for Health and Ageing


 

Schedule

 

1

Item No.

2

Medical Device Standard

3

Conditions

4

Essential Principle

1

ISO 10993-1: 2003  Biological evaluation of medical devices - Part 1 Evaluation and testing

 

Schedule 1, paragraph 7.1(b)

2

ISO 10993-3: 2003 Biological evaluation of medical devices - Part 3 Tests for genotoxicity, carcinogenicity and reproductive toxicity

 

 

Schedule 1, paragraph 7.1(b)

3

ISO 10993-4: 2002 Biological evaluation of medical devices - Part 4 Selection of tests for interactions with blood

 

AND

 

ISO 10993-4: 2002 Biological evaluation of medical devices - Part 4 Selection of tests for interactions with blood

Amendment 1:2006

 

 

Schedule 1, paragraph 7.1(b)

4

ISO 10993-5: 1999  Biological evaluation of medical devices - Part 5 Tests for in vitro cytotoxicity

 

 

Schedule 1, paragraph 7.1(b)

5

ISO 10993-6: 2007  Biological evaluation of medical devices - Part 6 Tests for local effects after implantation

 

 

Schedule 1, paragraph 7.1(b)

6

ISO 10993-7: 1995 Biological evaluation of medical devices - Part 7 Ethylene oxide sterilization residuals

 

 

Schedule 1, paragraph 7.1(b)

7

ISO 10993-9: 1999  Biological evaluation of medical devices - Part 9 Framework for identification and quantification of potential degradation products

 

 

Schedule 1, paragraph 7.1(b)

8

ISO 10993-10:2002  Biological evaluation of medical devices - Part 10 Tests for irritation and delayed-type hypersensitivity

 

AND

 

ISO 10933-10:2002 Biological evaluation of medical devices - Part 10 Tests for irritation and delayed- type hypersensitivity

Amendment 2006

 

 

Schedule 1, paragraph 7.1(b)

9

ISO 10993-11: 2006 Biological evaluation of medical devices – Part 11 Tests for systemic toxicity

 

 

Schedule 1, paragraph 7.1(b)

10

ISO 10993-12: 2007 Biological evaluation of medical devices - Part 12 Sample preparation and reference materials

 

 

Schedule 1, paragraph 7.1(b)

11

ISO 10993-13: 1998 Biological evaluation of medical devices - Part 13 Identification and quantification of degradation products from polymeric medical devices

 

 

Schedule 1, paragraph 7.1(b)

12

ISO 10993-14: 2001 Biological evaluation of medical devices - Part 14 Identification and quantification of degradation products from ceramics

 

 

Schedule 1, paragraph 7.1(b)

13

ISO 10993-15: 2000 Biological evaluation of medical devices - Part 15 Identification and quantification of degradation products from metals and alloys

 

 

Schedule 1, paragraph 7.1(b)

14

ISO 10993-16: 1997 Biological evaluation of medical devices - Part 16 Toxicokinetic study design for degradation products and leachables

 

 

Schedule 1, paragraph 7.1(b)

15

ISO 10993-17: 2002 Biological evaluation of medical devices – Part 17  Establishment of allowable limits for leachable substances

 

 

Schedule 1, paragraph 7.1(b)

16

ISO 10993-18: 2005 Biological evaluation of medical devices – Part 18  Chemical characterization of materials

 

 

Schedule 1, paragraph 7.1(b)