ISO 1135-5:2015

Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus

Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus

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Referenced standards

EN 15986:2011IISO 10993-1:2009ISO 10993-4:2002ISO 11135:2014ISO 11137-1:2006ISO 11137-2:2013ISO 11137-3:2006ISO 291:2008ISO 3696:1987ISO 3826-1:2013ISO 3826-2:2008ISO 594-1:1986ISO 594-2:1998ISO 7000:2014ISO 7864:1993
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ISO 1135-5:2015

Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus

Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus

ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.

Secondary aims of ISO 1135-5:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.

Platelet components should not be transfused under pressure using these sets.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.

Edition2015
Standard Part No5
Published Date2015
Published ByInternational Standardization Organisation
Page Count20