Commonwealth legislation

Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

3/10 complexity

This Order mandates safety and technical requirements for disposable U‑100 insulin syringes by adopting Australian Standard AS 1077‑1992, with three tweaks: 0.25 ml syringes are treated like 0.3 ml, five provisions on batch coding/expiry dating are removed, and referenced documents are fixed as at 1 Nov 1992.

It binds manufacturers and suppliers in Australia and protects diabetes patients and clinicians by ensuring sterility, accurate calibration and mechanical safety.

JSON API Health / NDIS / medicines

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992).

Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992)

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);

“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

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992)