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Conformity assessment standards order No. 2

Conformity assessment standards for quality assurance techniques for animal tissues and their derivatives utilised in the manufacture of medical devices

Published in the Commonwealth of Australia Gazette No. GN 9, 5 March 2003

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COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

CONFORMITY ASSESSMENT STANDARDS ORDER NO. 2

Conformity Assessment Standards for Quality Assurance Techniques for Animal Tissues and their Derivatives utilised in the Manufacture of Medical Devices

I, RITA MACLACHLAN, delegate of the Minister for Health and Ageing for the purposes of section 41DC of the Therapeutic Goods Act 1989 and acting under that section, DETERMINE:

  1. that the matters specified in column 2 of an item in the Schedule constitute a conformity assessment standard for quality assurance techniques for controls applicable to non-viable animal tissues and their derivatives utilised in the manufacture of medical devices, subject to the conditions (if any) set out in column 3 of that item of the Schedule, and
  2. quality assurance techniques of those kinds that comply with the standard are to be treated as complying with those parts of the conformity assessment procedures 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

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Schedule

1
Item No.		 2
Conformity Assessment Standard		 3
Conditions		 4
Conformity Assessment Procedure
1

EN 12442-1: 2000
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk

Part 1 of this standard is amended as follows:

Delete clause 1.1 and replace with:

"1.1 This Part of EN 12442 applies to animal tissues and their derivatives, which are non viable or rendered non-viable, utilised in the manufacture of medical devices (excluding in vitro diagnostic medical devices). It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis)."

Delete clause 4.2.2 and replace with:

"4.2.2 Is the animal tissue or its derivative intended to contact the patient or other persons?"

AND

EN 12442-2: 2000
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling

Part 2 of this standard is amended as follows:

Delete the NOTE under Clause 5 and replace with the normative statement:

"Clauses 5, 6, 7, 8 and 9 shall be applied and documented by suppliers of animal materials, intermediaries and medical device manufacturers as relevant."

Delete the NOTE under Clause 6.2 and replace with the normative statement:

"For relevant species, animals shall be subject to ante-mortem veterinary inspection. Prior to certification, a post-mortem inspection shall be performed immediately after slaughter and should include:

  1. visual inspection;
  2. palpation of specified organs;
  3. incision of organs and lymph nodes;
  4. investigation of anomalies, for example inconsistency, colour and smell;
  5. laboratory tests, if inspections carried out in (a) to (d) are inconclusive."

AND

EN 12442-3: 2000
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents.

Part 3 of this standard is amended as follows:

Under Annex C
Delete (informative)
Replace with (normative)

In EN 12442-3: 2000, all references to Annex C are taken as being normative.

Full documented compliance with each standard, as amended, is required, except for:

Clauses 4.2.4 to 4.2.21 inclusive of EN 12442-1: 2000.

Schedule 3
Part 1
Clauses 1.4
Sub clauses (5)(d) and (5)(e)

Schedule 3
Part 4
Clauses 4.4
Sub clauses (5)(c) and (5)(d)

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