NF EN ISO 1135-4

NF EN ISO 1135-4

April 2016
Standard Current

Transfusion equipment for medical use - Part 4 : transfusion sets for single use, gravity feed

ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.Secondary aims of ISO 1135-4:2015 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 a range of cellular and plasma blood components.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2016

Number of pages

28 p.

Reference

NF EN ISO 1135-4

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-253-4

Print number

1

International kinship

ISO 1135-4:2015

European kinship

EN ISO 1135-4:2015
Sumary
Transfusion equipment for medical use - Part 4 : transfusion sets for single use, gravity feed

ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

Secondary aims of ISO 1135-4:2015 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 a range of cellular and plasma blood components.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.

Replaced standards (1)
NF EN ISO 1135-4
August 2012
Standard Cancelled
Transfusion equipment for medical use - Part 4 : transfusion sets for single use

ISO 1135-4:2011 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of ISO 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Exigences générales
  • 4 Matériaux
  • 5 Exigences physiques
  • 6 Exigences chimiques
  • 7 Exigences biologiques
  • 8 Étiquetage
  • 9 Emballage
  • 10 Élimination
  • Annexe A Essais physiques
  • Annexe B Essais chimiques
  • Annexe C Essais biologiques
  • Bibliographie
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