{"id":"F2007B00476","name":"Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags (23/02/2001)","slug":"therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":62332,"registerId":"commonwealth-F2007B00476-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags (23/02/2001)","content":"COMMONWEALTH OF AUSTRALIA\n\nTherapeutic Goods Act 1989\n\nTHERAPEUTIC GOODS ORDER NO.68\n\nStandard for Plasticized Polyvinyl Chloride (PVC) Blood Bags\n\nI, 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,\n\nhaving consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the said Act, HEREBY:\n\nDETERMINE that the matters specified in the following Australian Standards shall constitute the standard for the kind of blood bags described:\n\n(a) AS 3787.1-1997 General requirements for single-use, sterile plasticized polyvinyl  \nchloride (PVC) packs for human blood Part 1:Single blood packs shall constitute the  \nstandard for all single blood packs; and\n\n(b) AS 3787.2-1997 General requirements for single-use, sterile, plasticized polyvinyl  \nchloride (PVC) packs for human blood Part 2:Multiple blood pack systems shall  \nconstitute the standard for all multiple blood pack systems\n\nThis order commences on the date this Order is gazetted.\n\nDated on this 23rd day of February 2001\n\nSigned Terry Slater\n\nTerry Slater\n\nDelegate of the Minister for Health and Aged Care","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1307},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This is the original determination establishing the standard. The scope is tightly confined to adopting specific Australian Standards for PVC blood bags, with no evidence of expansion beyond this original technical purpose."},"complexity_factors":["Extensive incorporation by reference to external technical standards (AS 3787.1-1997 and AS 3787.2-1997)","Very short primary legislative text (under 200 words)","No defined terms or interpretation provisions within the Order itself","No conditional logic, exceptions, or procedural requirements"],"plain_english_summary":"This Order sets the mandatory safety and quality standards for plasticized PVC blood bags used to collect, store, and transport human blood in Australia.\n\n**What it does:**\nInstead of spelling out technical requirements directly, this Order \"imports\" two existing Australian Standards and makes them legally binding:\n- **AS 3787.1-1997** applies to **single blood packs** (individual bags used for blood collection)\n- **AS 3787.2-1997** applies to **multiple blood pack systems** (connected sets of bags used for separating blood components)\n\n**Why it matters:**\nThese standards ensure blood bags are sterile, won't leak or break during handling, and won't release harmful chemicals (like plasticizers) into the blood supply. This protects patients receiving transfusions from contamination or infection risks.\n\n**Who it affects:**\nManufacturers and suppliers of blood collection equipment in Australia must ensure their products meet these referenced standards. Health facilities can rely on compliant bags being safe for clinical use."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001","history":"/api/acts/therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001/history","analysis":"/api/acts/therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001/important-cases","documents":"/api/acts/therapeutic-goods-order-no-68-standard-for-plasticized-polyvinyl-chloride-pvc-blood-bags-23-02-2001/documents"}}