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BS EN ISO 1135-4:2015 Transfusion equipment for medical use - Transfusion sets for single use, gravity feed >
BS EN ISO 1135-4:2015 Transfusion equipment for medical use - Transfusion sets for single use, gravity feed, 2016
- European foreword
- Endorsement notice
- Table 1 — Correlations between undated normative references and dated EN and ISO standards
- Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices
- Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC, Medical devices
- Foreword
- 1 Scope
- 2 Normative references
- 3 General requirements
- 3.1 Nomenclature for components of the transfusion set
- 3.2 Maintenance of sterility
- 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
- 7.6 Assessment of blood component depletion
- 7.7 Assessment of damage to blood components
- 8 Labelling
- 8.1 General
- 8.2 Unit container
- 8.3 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 [Go to Page]