BAS EN ISO 1135-5:2017

Transfuzijska oprema za medicinsku upotrebu - Dio 5: Transfuzijski setovi za jednokratnu upotrebu za infuzione aparate pod pritiskom


Опште информације
Статус: Важећи
Број страна: 26
Језик: Енглески
Издање: 1.
Метода усвајања: Proglašavanje
Датум објаве: 28.06.2017
Технички комитет:
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Апстракт
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.

Животни циклус
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Изворни документ и степен усаглашености
  • EN ISO 1135-5:2015, идентичан
  • ISO 1135-5:2015, идентичан

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