Commonwealth legislation

Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags (23/02/2001)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

2/10 complexity

This Order sets the mandatory safety and quality standards for plasticized PVC blood bags used to collect, store, and transport human blood in Australia.

What it does: Instead of spelling out technical requirements directly, this Order "imports" two existing Australian Standards and makes them legally binding:

AS 3787.1-1997 applies to single blood packs (individual bags used for blood collection)
AS 3787.2-1997 applies to multiple blood pack systems (connected sets of bags used for separating blood components)

Why it matters: These 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.

Who it affects: Manufacturers 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.

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags (23/02/2001).

Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags (23/02/2001)

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

THERAPEUTIC GOODS ORDER NO.68

Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags

I, 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,

having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the said Act, HEREBY:

DETERMINE that the matters specified in the following Australian Standards shall constitute the standard for the kind of blood bags described:

(a) AS 3787.1-1997 General requirements for single-use, sterile plasticized polyvinyl
chloride (PVC) packs for human blood Part 1:Single blood packs shall constitute the
standard for all single blood packs; and

(b) AS 3787.2-1997 General requirements for single-use, sterile, plasticized polyvinyl
chloride (PVC) packs for human blood Part 2:Multiple blood pack systems shall
constitute the standard for all multiple blood pack systems

This order commences on the date this Order is gazetted.

Dated on this 23rd day of February 2001

Signed Terry Slater

Terry Slater

Delegate of the Minister for Health and Aged Care

Source text

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

1 Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags (23/02/2001)