{"id":"F2007B00457","name":"Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992)","slug":"therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":62315,"registerId":"commonwealth-F2007B00457-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992)","content":"THERAPEUTIC GOODS ACT 2989\n\nTHERAPEUTIC GOODS ORDER NO 41\n\nSingle-use syringes (sterile for the injection of 100 units per millilitre insulin (U-100)\n\nI, 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\n\nsyringes (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:\n\n(a) in Clause 1, under the heading “SCOPE”, after the first  \nsentence, insert:\n\n“Syringes of 0.25 ml capacity shall comply with the  \nrequirements for 0.3ml syringes.”;\n\n(b) delete the following provisions in Clause 23:\n\n\\- 23.2(b)(vii);\n\n\\- 23.2(b)(viii);\n\n\\- 23.2(f);\n\n\\- 23.3(b)(vii) and\n\n\\- 23.3(b)(viii);\n\n(c) add after Subclause 23.5 the following Clause:\n\n“24. A reference in this Standard to another document is  \ntaken to be a reference to the document as in force on 1  \nNovember 1992.”.\n\n  \nThis Order commences on 16 January 1993.\n\nDated this 9th day of November 1992\n\nJOHN CABLE\n\nDelegate of the Minister of State for Aged, Family and Health Services","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":3186},"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This is the original making of the Order, establishing standards specifically for U-100 insulin syringes without expansion beyond this stated purpose."},"complexity_factors":["Incorporation by reference of extensive external technical standard (AS 1077-1992) including Clauses 1-23 and Appendices A to O","Selective deletion of five specific sub-clauses requiring cross-referencing to original standard text","Technical medical device specifications involving sterility, biocompatibility and metrology"],"plain_english_summary":"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. \n\nIt binds manufacturers and suppliers in Australia and protects diabetes patients and clinicians by ensuring sterility, accurate calibration and mechanical safety."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili","history":"/api/acts/therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili/history","analysis":"/api/acts/therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili/important-cases","documents":"/api/acts/therapeutic-goods-order-no-41-single-use-syringes-sterile-for-the-injection-of-100-units-per-millili/documents"}}