Federal Register of Legislation - Australian Government

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Orders/Other as amended, taking into account amendments up to Therapeutic Goods Order No. 67A
Administered by: Health
Registered 25 May 2007
Start Date 14 Aug 2003
End Date 19 Mar 2014
Date of repeal 19 Mar 2014
Repealed by

Therapeutic Goods Order No. 67 - Standard for Dental Materials

as amended

made under section 10 of the

This compilation was prepared on 9 May 2007
taking into account amendments up to Therapeutic Goods Order No. 67A - Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra


 


  

  

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 section 10 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.

 


Schedule           Dental Materials

  

 

Column 1

Standard

Column 2

Goods

ISO 1559-1995 (E)
“Dental materials ‑ Alloys for dental amalgam”
Third edition

Alloys for dental amalgam

ISO 1560 – 1985 (E)
“Dental mercury”
Second edition

Dental mercury

ISO 6876 – 1986 (E)
“Dental root canal sealing
Materials”
Second edition

Dental root canal sealing
materials

ISO 3107: 1988 (E)
“Dental zinc oxide/eugenol
cements and zinc oxide
non‑eugenol cements”
Second edition

Dental zinc oxide/eugenol
cements and zinc oxide
non‑eugenol cements

ISO 6874: 1988 (E)
“Dental resin‑based pit
and fissure sealants”
First edition

Dental resin‑based pit
and fissure sealants

ISO Standard 4049: 2000
Dentistry – Polymer-based filling, restoration and luting materials,
Third edition

Polymer-based filling, restoration
and luting materials


Notes to the Therapeutic Goods Order No. 67 - Standard for Dental Materials

Note 1

The Therapeutic Goods Order No. 67 - Standard for Dental Materials in force under section 10 of the Therapeutic Goods Act 1989 as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title

Date of notification
in Gazette

Date of
commencement

Application, saving or
transitional provisions

Therapeutic Goods Order No. 67 – Standard for Dental Materials (F2007B00467)

14 Mar 2001 (see
Gazette
2001,
No. GN10)

14 Mar 2001

 

Therapeutic Goods Order No. 67A – Amendment to Therapeutic Goods Order No. 67 – Standard for Dental Materials (F2007B00466)

14 Aug 2002 (see
Gazette
2002,
No. GN32)

14 Aug 2003

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted

Provision affected

How affected

Schedule

 

Schedule................................

am. Order No. 67A