NF EN ISO 8536-15
NF EN ISO 8536-15

NF EN ISO 8536-15

March 2022
Standard Current

Infusion equipment for medical use - Part 15 : light-protective infusion sets for single use

This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

Main informations

Collections

National standards and national normative documents

Publication date

March 2022

Number of pages

18 p.

Reference

NF EN ISO 8536-15

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-15

Print number

1

International kinship

ISO 8536-15:2022

European kinship

EN ISO 8536-15:2022
Sumary
Infusion equipment for medical use - Part 15 : light-protective infusion sets for single use

This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).

This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Matériaux
  • 6 Exigences physiques
  • 7 Exigences chimiques
  • 8 Exigences biologiques
  • 9 Etiquetage
  • 10 Emballage
  • 11 Mise au rebut
  • Annexe A (normative) Détermination de la transmission de lumière
  • Annexe B (normative) Essai de décoloration - Méthode physique
  • Annexe C (normative) Méthode d'essai chimique pour la détermination de la décoloration - Colorimétrie par détection visuelle
  • Bibliographie
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