BS EN ISO 1135-5:2015
Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus
Standard number: | BS EN ISO 1135-5:2015 |
Pages: | 32 |
Released: | 2016-01-31 |
ISBN: | 978 0 580 83090 7 |
Status: | Standard |
BS EN ISO 1135-5:2015
This standard BS EN ISO 1135-5:2015 Transfusion equipment for medical use is classified in these ICS categories:
- 11.040.20 Transfusion, infusion and injection equipment
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.
Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
Hypodermic needles for single use. Colour coding for identification
Textiles. Test methods for nonwovens Lint and other particles generation in the dry state