Standard Svensk standard · SS-EN ISO 1135-5:2016

Transfusionsutrustning för medicinskt bruk - Del 5: Transfusionsaggregat för engångsbruk, pumpstyrd infusion (ISO 1135-5:2015)

Status: Gällande

Omfattning
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.

Ämnesområden

Utrustning för transfusion, infusion och injektion (11.040.20)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

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

Artikelnummer: STD-8018269

Utgåva: 1

Fastställd: 2016-01-11

Antal sidor: 36

Ersätter: SS-EN ISO 1135-4:2012