DS/EN ISO 1135-5:2015

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

Status:
Current
Type:
Standard
Language:
English
Subject:
Sundhed
Price from:
€ 74.62
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Legislation

Links

Scope

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.

Replaces:

Number of pages: 34

Published: 2016-01-28

Date of approval: 2016-01-07

International relationships : EN ISO 1135-5:2015 IDT ISO 1135-5:2015 IDT

ICS: 11.040.20 - Transfusion, infusion and injection equipment

Item number: M274890

Committees

Committee

  • CEN/TC 205
  • ISO/TC 76
  • ISO/TC 76/WG 1

Danish committee

DS/S-093