NF EN ISO 8637-2

NF EN ISO 8637-2

April 2024
Standard Current

Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.This document does not apply to:?     haemodialysers, haemodiafilters or haemofilters;?     plasmafilters;?     haemoperfusion devices;?     vascular access devices.NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2024

Number of pages

44 p.

Reference

NF EN ISO 8637-2

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
11.040.60   Therapy equipment

Classification index

S93-302-2

Print number

1

International kinship

ISO 8637-2:2024

European kinship

EN ISO 8637-2:2024
Sumary
Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.

This document does not apply to:

?     haemodialysers, haemodiafilters or haemofilters;

?     plasmafilters;

?     haemoperfusion devices;

?     vascular access devices.

NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.

NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

Replaced standards (1)
NF EN ISO 8637-2
August 2018
Standard Cancelled
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.

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