THERAPEUTIC GOODS ACT 2989

THERAPEUTIC GOODS ORDER NO 41

Single-use syringes (sterile for the injection of 100 units per millilitre insulin (U-100)

I, JOHN CABLE, delegate of the Minister of State for Aged, Family and Health Services for the purposes of the exercise of his powers under s.10 of the Therapeutic Goods Act 1989 and acting under that Section, DETERMINE that the matters specified in Clauses 1 to 23 inclusive and Appendices A to O inclusive, in the fourth edition of the document titles “AS 1077-1992 Australian Standard – Single-use

syringes (sterile) for the injection of 100 units per millilitre insulin (U-100)” published by Standards Australia (Standards Association of Australia) and as in force on 1 November 1992, constitute standards for single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100), subject to the following modifications:

(a)   in Clause 1, under the heading “SCOPE”, after the first
      sentence, insert:

      “Syringes of 0.25 ml capacity shall comply with the
      requirements for 0.3ml syringes.”;

(b)   delete the following provisions in Clause 23:

-       23.2(b)(vii);

-       23.2(b)(viii);

-       23.2(f);

-       23.3(b)(vii) and

-       23.3(b)(viii);

(c)   add after Subclause 23.5 the following Clause:

      “24. A reference in this Standard to another document is
           taken to be a reference to the document as in force on 1
           November 1992.”.

This Order commences on 16 January 1993.

Dated this 9th day of November 1992

JOHN CABLE

Delegate of the Minister of State for Aged, Family and Health Services