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    • CSA ISO 8637-1:21

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    CSA ISO 8637-1:21

    Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Adopted ISO 8637-1:2017, first edition, 2017-11)

    SKU: 2702814 Published by CSA Group Publication Year 2021

    Product Details

    • Preface/Scope
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    CSA Preface


    This is the first edition of CSA ISO 8637-1, Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption without modification of the identically titled ISO (International Standards Organization) Standard 8637-1 (first edition, 2017-11). It replaces CAN/CSA-ISO 8637:12 (adopted ISO 8637:2010), Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.


    CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).


    This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


    Scope


    WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.


    This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as the device, for use in humans.


    This document 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.

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    CSA ISO 8637-1:21

    Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Adopted ISO 8637-1:2017, first edition, 2017-11)

    Active
    English

    CSA ISO 8637-1:F21

    Systèmes extracorporels pour la purification du sang — Partie 1 : Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (norme ISO 8637-1:2017 adoptée, première édition, 2017-11)

    Active
    French

    CAN/CSA-ISO 8637A:12 (R2017)

    Amendment 1:2015 to CAN/CSA-ISO 8637:12, Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports (Adopted amendment 1:2013 to ISO 8637:2010)

    Withdrawn
    English

    CAN/CSA-ISO 8637:12 (R2017)

    Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Adopted ISO 8637:2010, third edition, 2010-07-01)

    Withdrawn
    English

    CAN/CSA-ISO 8637:F12 (C2017)

    Implants cardiovasculaires et systèmes extracorporels - Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (norme ISO 8637:2010 adoptée, troisième édition, 2010-07-01)

    Withdrawn
    French

    CAN/CSA-Z8637-08

    Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators (Adopted ISO 8637:2004, second edition, 2004-10-01, with Canadian deviations)

    Withdrawn
    English
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