Federal Register of Legislation - Australian Government

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TGO No. 67 Orders/Other as made
This Order relates to the standard for dental material. It revokes Therapeutic Goods Order No. 57.
Administered by: Health
Registered 05 Apr 2007
Tabling HistoryDate
Tabled HR26-Mar-2001
Tabled Senate26-Mar-2001
Gazetted 14 Mar 2001
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

COMMONWEALTH OF AUSTRALIA

 

Therapeutic Goods Act 1989

 

THERAPEUTIC GOODS ORDER NO. 67

 

Standard for Dental Materials

 

I, TERRY SLATER, delegate of the Minister of State for Health and Aged Care for the purposes of section 10 of the Therapeutic Goods Act 1989 and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the said Act, HEREBY:

 

(1)   REVOKE Therapeutic Goods Order No.57 “Dental Materials”, signed by the delegate

      on 7 April 1997 and gazetted on 23 April 1997; and

 

(2)   DETERMINE THAT:

 

   (a)  the matters specified in each of the International Standards made and published by    
         the International Organisation for Standardisation, listed in Column 1 of the 
         Schedule to this Order, constitute a standard for the therapeutic goods, or class of 
         therapeutic goods, described in Column 2 of the Schedule in relation to that
         International Standard; and

 

   (b)  the International Standards ISO 9917:1991(E) Dental water-based cements and ISO 
         9917-2:1998(E) Dental water-based cements – Part 2: Light-activated cements
        
shall both constitute the standard for water=based dental cements, subject to the 
         following modification:

 

(i)                  Subclause 8.2 (Marking) of ISO 9917:1991 (E) Dental water-based  cements, shall be omitted and replaced with the following new subclause 8.2:

 

“8.2 Marking

The requirements of Therapeutic Goods Order No. 37 General Requirements for Labels for Therapeutic Devices shall apply.” ; and

 

(ii)                Subclause 8.2 (Marking) of ISO 9917-2 1998(e) Dental water-based cements – Part 2: Light-activated cements, shall be omitted and replaced with the following new subclause 8.2:

 

8.2 Marking

The requirements of Therapeutic Goods Order No 37 General Requirements for Labels for Therapeutic Devices shall apply.”

 

 

 

 

 

 

This Order commences on the date this Order is gazetted in the Commonwealth Gazette.

 

Dated this 23rd day of February 2001

 

 

 

 

 

TERRY SLATER

Delegate of the Minister for Health and Aged Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCHEDULE

 

 

Dental Materials

 

Column 1                                                                     Column 2

Standard                                                          Goods

 

 

ISO 1559-1995 (E)                                                     Alloys for dental amalgam

“Dental materials - Alloys for dental

amalgam”

Third edition

 

ISO 1560 – 1985 (E)                                                   Dental mercury

“Dental mercury”

Second edition

 

ISO 6876 – 1986 (E)                                                   Dental root canal sealing

“Dental root canal sealing                                                          materials

Materials”

Second edition

 

ISO 3107: 1988 (E)                                                     Dental zinc oxide/eugenol

“Dental zinc oxide/eugenol                                            cements and zinc oxide

cements and zinc oxide                                                 non-eugenol cements

non-eugenol cements”

Second edition

 

ISO 6874: 1988 (E)                                                     Dental resin-based pit

“Dental resin-based pit                                                  and fissure sealants

and fissure sealants”

First edition

 

ISO 4049: 1988 (E)

“Dentistry – resin-based filling                                       Dental resin-based filling

materials”                                                                     materials

Second edition

including Technical Corrigendum 1:1992