AS 8536-2006

1 - AS 8536-2006 Infusion sets for single use, gravity feed
4 - PREFACE
5 - CONTENTS
7 - 1 Scope
7 - 2 Normative references
7 - 3 General requirements
10 - 4 Designation
10 - 4.1 Infusion set
10 - 4.2 Air-inlet device
10 - 5 Materials
11 - 6 Physical requirements
11 - 6.1 Particulate contamination
11 - 6.2 Leakage
11 - 6.3 Tensile strength
11 - 6.4 Closure-piercing device
11 - 6.5 Air-inlet device
12 - 6.6 Tubing
12 - 6.7 Fluid filter
12 - 6.8 Drip chamber and drip tube
12 - 6.9 Flow regulator
12 - 6.10 Flow rate of infusion fluid
12 - 6.11 Injection site
12 - 6.12 Male conical fitting
12 - 6.13 Protective caps
13 - 7 Chemical requirements
13 - 7.1 Reducing (oxidizable) matter
13 - 7.2 Metal ions
13 - 7.3 Titration acidity or alkalinity
13 - 7.4 Residue on evaporation
13 - 7.5 UV absorption of extract solution
13 - 8 Biological requirements
13 - 8.1 General
13 - 8.2 Sterility
13 - 8.3 Pyrogenicity
13 - 8.4 Haemolysis
14 - 8.5 Toxicity
14 - 9 Labelling
14 - 9.1 Unit container
14 - 9.2 Shelf or multi-unit container
15 - 10 Packaging
16 - Annex A (normative) Physical tests
20 - Annex B (normative) Chemical tests
22 - Annex C (normative) Biological tests
23 - Bibliography

Adopts ISO 8536-4:2004 to specify requirements for single use gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment and provides guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

Originated as part of AS 2385-1980.
Previous edition part of AS 2385-1990.
Revised in part and redesignated as AS 8536-2006.