Skip to content
Please enter a keyword to search

  • BS EN 1283:1996

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2014

    Language(s):  English

    Published date:  15-11-1996

    Publisher:  British Standards Institution

    Add To Cart

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

    Committees responsible
    National foreword
    Foreword
    0 Introduction
    1 Scope
    2 Normative reference
    3 Definitions
    4 Requirements
    5 Test methods
    6 Packaging
    7 Information provided by the manufacturer
    Annex A (informative) Bibliography
    Figures
    1 Main fitting dimensions of blood inlet and outlet
       connections
    2 Main fitting dimensions of extracorporeal circuit
       connector to blood ports of haemodialyser, haemofilter,
       or haemoconcentrator
    3 Length of engagement of male and female cones of
       blood inlet and outlet connectors
    4 Main fitting dimensions of dialysing fluid inlet
       and outlet port
    5 Schematic test circuit for determination of the
       clearances of haemodialysers and haemodiafilters
    6 Schematic test circuit for determination of sieving
       coefficients of haemodiafilters, haemofilters and
       haemoconcentrators
    7 Schematic test circuit for the determination of the
       ultrafiltration rate

    Abstract - (Show below) - (Hide below)

    States requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuits for these devices intended for renal care and cardiovascular use on humans. (includes any integral accessory lines, eg fluid and infusion lines and lines for connecting to pressure monitors).

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

    Committee CH/150/2
    Development Note Supersedes BS 7297-1(1990), BS 7297-2(1990) and 94/501163 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    BS EN ISO 10993-11:2009 Biological evaluation of medical devices Tests for systemic toxicity
    BS 5750-2:1987 Quality systems Specification for production and installation
    BS EN 46002:1997 Specification for application of EN ISO 9002 to the manufacture of medical devices
    BS EN 980:2008 Symbols for use in the labelling of medical devices
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    BS EN 30993-1:1994 Biological evaluation of medical devices Guidance on selection of tests
    BS 5750-1:1987 Quality systems Specification for design/development, production, installation and servicing
    BS EN ISO 10993-7:2008 Biological evaluation of medical devices Ethylene oxide sterilization residuals
    BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    BS 3930-2:1991 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment Specification for lock fittings
    BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective