Transfusion equipment for medical use - Transfusion sets for single use

BS EN ISO 1135-4:2010 Transfusion equipment for medical use. Transfusion sets for single use

BS EN ISO 1135-4 specifies 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.

ISO 1135-4 also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, and presents designations for transfusion set components.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over BS EN ISO 1135-4.

Contents of BS EN ISO 1135-4:

Foreword

1 Scope

2 Normative references

3 General requirements

3.1 Nomenclature for components of the transfusion set

3.2 Maintenance of sterility

3.3 Designation

4 Materials

5 Physical requirements

5.1 Particulate contamination

5.2 Leakage

5.3 Tensile strength

5.4 Closure-piercing device

5.5 Tubing

5.6 Filter for blood and blood components

5.7 Drip chamber and drip tube

5.8 Flow regulator

5.9 Flow rate of blood and blood components

5.10 Injection site

5.11 Male conical fitting

5.12 Protective caps

6 Chemical requirements

6.1 Reducing (oxidizable) matter

6.2 Metal ions

6.3 Titration acidity or alkalinity

6.4 Residue on evaporation

6.5 UV absorption of extract solution

7 Biological requirements

7.1 General

7.2 Sterility

7.3 Pyrogenicity

7.4 Haemolysis

7.5 Toxicity

8 Labelling

8.1 Unit container

8.2 Shelf or multi-unit container

9 Packaging

10 Disposal

Annex A (normative) Physical tests

Annex B (normative) Chemical tests

Annex C (normative) Biological tests

Bibliography