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  • BS EN ISO 8637:2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-04-2020

    Language(s):  English

    Published date:  31-03-2014

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    6 Labelling
    Bibliography
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on medical devices

    Abstract - (Show below) - (Hide below)

    Defines requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as 'the device', for use in humans.

    Scope - (Show below) - (Hide below)

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

    This International Standard is not applicable 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 used 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 8638.

    General Product Information - (Show below) - (Hide below)

    Committee CH/150/2
    Development Note Together with BS EN ISO 8638, It supersedes BS EN 1283. Supersedes 13/30280718 DC. (04/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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