NF EN ISO 8536-4

NF EN ISO 8536-4

January 2020
Standard Current

Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2020

Number of pages

28 p.

Reference

NF EN ISO 8536-4

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-4

Print number

2 - 01/02/2021

International kinship

ISO 8536-4:2019

European kinship

EN ISO 8536-4:2020
Sumary
Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

Replaced standards (2)
NF EN ISO 8536-4
August 2013
Standard Cancelled
Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

NF EN ISO 8536-4/A1
April 2013
Standard Cancelled
Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed

Le présent document est l'amendement 1 à la norme homologuée NF EN ISO 8536-4 de janvier 2011. Il modifie les paragraphes 9.1, 9.2, l'Article 11, le paragraphe A.2, la Figure A.1, le paragraphe A.6 ainsi que la Bibliographie.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Désignation
  • 6 Matériaux
  • 7 Exigences physiques
  • 8 Exigences chimiques
  • 9 Exigences biologiques
  • 10 Étiquetage
  • 11 Emballage
  • 12 Mise au rebut
  • Annexe A Essais physiques
  • Annexe B Essais chimiques
  • Annexe C Essais biologiques
  • Bibliographie
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