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.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

March 2022

Number of pages

20 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
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ