AS 4885-2006

1 - AS 4885-2006 Transfusion sets for single use
4 - PREFACE
5 - CONTENTS
7 - 1 Scope
7 - 2 Normative references
7 - 3 General requirements
7 - 3.1 Nomenclature for components of the transfusion set
9 - 3.2 Maintenance of sterility
9 - 3.3 Designation
10 - 4 Materials
10 - 5 Physical requirements
10 - 5.1 Particulate contamination
10 - 5.2 Leakage
10 - 5.3 Tensile strength
10 - 5.4 Closure-piercing device
11 - 5.5 Air-inlet device
11 - 5.6 Tubing
11 - 5.7 Filter for blood and blood components
11 - 5.8 Drip chamber and drip tube
11 - 5.9 Flow regulator
11 - 5.10 Flow rate of blood and blood components
12 - 5.11 Injection site
12 - 5.12 Male conical fitting
12 - 5.13 Protective caps
12 - 6 Chemical requirements
12 - 6.1 Reducing (oxidizable) matter
12 - 6.2 Metal ions
12 - 6.3 Titration acidity or alkalinity
12 - 6.4 Residue on evaporation
12 - 6.5 UV absorption of extract solution
13 - 7 Biological requirements
13 - 7.1 General
13 - 7.2 Sterility
13 - 7.3 Pyrogenicity
13 - 7.4 Haemolysis
13 - 7.5 Toxicity
13 - 8 Labelling
13 - 8.1 Unit container
14 - 8.2 Shelf or multi-unit container
14 - 9 Packaging
15 - Annex A (normative) Physical tests
19 - Annex B (normative) Chemical tests
21 - Annex C (normative) Biological tests
22 - Bibliography

Adopts ISO 1135-4:2004 to specify requirements for single use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components.

Originated as part of AS 2385-1980.
Previous edition part of AS 2385-1990.
Revised in part and redesignated as AS 4885-2006.