NF EN ISO 8637

NF EN ISO 8637

March 2014
Standard Cancelled

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

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National standards and national normative documents

Publication date

March 2014

Number of pages

28 p.

Reference

NF EN ISO 8637

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
11.040.60   Therapy equipment

Classification index

S93-302

Print number

1

International kinship

ISO 8637:2010

European kinship

EN ISO 8637:2014
Sumary
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

Replaced standards (1)
NF EN 1283
June 1996
Standard Cancelled
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits.

Le présent document détermine les méthodes pour la vérification des caractéristiques physiques et biologiques des hémodialyseurs, hémodiafiltres, hémofiltres, hémoconcentrateurs et circuits extracorporels.

Standard replaced by (2)
NF EN ISO 8637-2
August 2018
Standard Current
Extracorporeal systems for blood purification - Part 2 : extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — pressure monitors for the extracorporeal blood circuit; — air detection devices; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3. NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

NF EN ISO 8637-1
April 2020
Standard Current
Extracorporeal systems for blood purification - Part 1 : haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans. ISO 8637-1:2017 does not apply to: - extracorporeal blood circuits; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; - reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences
    4
  • 4.1 Sécurité biologique
    4
  • 4.2 Stérilité
    4
  • 4.3 Apyrogénéicité
    4
  • 4.4 Caractéristiques mécaniques
    4
  • 4.5 Caractéristiques de performance
    6
  • 4.6 Date de péremption
    7
  • 5 Méthodes d'essai
    7
  • 5.1 Généralités
    7
  • 5.2 Sécurité biologique
    8
  • 5.3 Stérilité
    8
  • 5.4 Apyrogénéicité
    8
  • 5.5 Caractéristiques mécaniques
    8
  • 5.6 Caractéristiques de performance
    9
  • 5.7 Date de péremption
    15
  • 6 Étiquetage
    16
  • 6.1 Étiquetage du dispositif
    16
  • 6.2 Étiquetage des conteneurs unitaires
    16
  • 6.3 Étiquetage des conteneurs externes
    17
  • 6.4 Documents d'accompagnement
    17
  • Bibliographie
    20
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