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

BS EN ISO 1135-4:2010

Transfusion equipment for medical use. Transfusion sets for single use

Status : Revised, Withdrawn   Published : May 2010 Replaced By : BS EN ISO 1135-4:2011

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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

 




Standard NumberBS EN ISO 1135-4:2010
TitleTransfusion equipment for medical use. Transfusion sets for single use
StatusRevised, Withdrawn
Publication Date31 May 2010
Withdrawn Date30 November 2011
Normative References(Required to achieve compliance to this standard)ISO 7864:1993, ISO 3696:1987, ISO 594-1:1986, ISO 14644-1:1999, ISO 3696, ISO 15223-1, ISO 10993-1, ISO 3826-1:2003, ISO 594-2:1998, ISO 7864
Informative References(Provided for Information)ISO 11135, ISO 11137, ISO 10993-1, IEC 80416-1, 93/42/EEC, ISO 17665-1, ISO 7000, ISO 10993-4:2017, ISO 291:1994
Replaced ByBS EN ISO 1135-4:2011
ReplacesBS EN ISO 1135-4:2004
International RelationshipsISO 1135-4:2010,EN ISO 1135-4:2010
Draft Superseded By08/30184486 DC
DescriptorsParenteral infusion equipment, Performance, Performance testing, Designations, Marking, Medical equipment, Blood transfusion equipment, Quality, Compatibility, Disposable, Physical properties of materials
ICS11.040.20
Title in FrenchMatériel de transfusion à usage médical. Appareils de transfusion non réutilisables
Title in GermanTransfusionsgeräte zur medizinischen Verwendung. Transfusionsgeräte zur einmaligen Verwendung
CommitteeCH/212
ISBN978 0 580 63593 9
PublisherBSI
FormatA4
DeliveryNo
Pages24
File Size547 KB
Price£186.00


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