SS-EN-ISO-1135-5 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)

SS-EN-ISO-1135-5 - 2016 EDITION - CURRENT


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This part of ISO 1135 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 this part of ISO 1135 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 this part of ISO 1135.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)


Medical devices

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Designation Name

SS-EN ISO 1135-5:2016

Revision Level

2016 EDITION

Status

Current

Publication Date

Jan. 11, 2016

Language(s)

English

Page Count

36

International Equivalent

EN ISO 1135-5:2015(IDT); ISO 1135-5:2015(IDT)