{"id":"F2007B00464","name":"Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods (27/11/1998)","slug":"therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":62322,"registerId":"commonwealth-F2007B00464-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods (27/11/1998)","content":"COMMONWEALTH OF AUSTRALIA\n\nTherapeutic Goods Act 1989\n\nTHERAPEUTIC GOODS ORDER No. 63\n\nStandard for Sterile Therapeutic Goods\n\nI, Elaine Walker, delegate of the Minister for Health and Aged Care for the purposes of the exercise of the Minister’s powers under section 10 of the Therapeutic goods Act 1989, acting under that section:\n\n(a) revoke Therapeutic Goods Order No. 11 – Standard for Sterile Therapeutic  \nGoods, which was made on 4 December 1983; and\n\n(b) determine that the requirements specified in the British Pharmacopoeia 1998,  \nAppendix XVI – Test for Sterility (European Pharmacopoeia, Supplement  \n1998, Biological Tests – Sterility) shall constitute the standard for therapeutic  \ndevices that are labelled as sterile or sterilised or otherwise purport to be sterile  \nor sterilised.\n\nThis Order takes effect on 1 December 1998.\n\nDated 27 November 1998\n\nELAINE WALKER\n\nDelegate of the Minister for Health and Aged Care\n\nNOTE\n\n1\\. By Ministerial Order in the Gazette, the British Pharmacopoeia 1998 takes effect in Australia on 1 December 1998. Accordingly, from 1 December 1998 the test for sterility of therapeutic goods applies as specified in Appendix XVI to the British Pharmacopoeia 1998. This Order extends the test to apply to therapeutic devices which are not specified in the British Pharmacopoeia.","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":2665},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":true,"description":"The order explicitly extends sterility testing requirements to therapeutic devices (medical devices) that are labeled as sterile but are not listed in the British Pharmacopoeia 1998. This broadens the application of pharmaceutical-grade sterility testing to cover device categories that were previously outside the scope of the British Pharmacopoeia standard, ensuring devices meet the same verification requirements as medicines."},"complexity_factors":["Incorporation by reference of external technical standard (British Pharmacopoeia 1998, Appendix XVI)","Adoption of European Pharmacopoeia testing methodology via the British standard","Application of pharmaceutical testing requirements to therapeutic devices not specified in the Pharmacopoeia"],"plain_english_summary":"This order replaces the old 1983 sterility standard and requires therapeutic goods labeled “sterile” or “sterilized” to be tested using the British Pharmacopoeia 1998 sterility method (the European Pharmacopoeia biological test). It explicitly applies that rigorous, internationally recognised test to both medicines and medical devices, affecting manufacturers, importers and suppliers and aiming to reduce infection risks for patients."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998","history":"/api/acts/therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998/history","analysis":"/api/acts/therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998/important-cases","documents":"/api/acts/therapeutic-goods-order-no-63-standard-for-sterile-therapeutic-goods-27-11-1998/documents"}}