Skip to content
Please enter a keyword to search

  • CSA ISO 5840 : 0

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  29-02-2008

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

    Add To Cart

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Valve description
    5 Material, component and valve assembly testing
    6 Hydrodynamic testing
    7 Durability testing
    8 Preclinical in vivo evaluation
    9 Clinical evaluation
    10 Packaging, labelling and instructions
    Annexes
    A Rationale for the provisions of this International
        Standard
    B Materials related to heart valve substitutes
    C Physical and material properties of heart valve
        substitutes and their components
    D Standards applicable to testing of materials and
        components of heart valve substitutes
    E Definitions of components of a heart valve substitute
    F Valve description

    Abstract - (Show below) - (Hide below)

    Defines tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve substitutes of all types, and of the materials and components of which they are made.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn

    Standards Referenced By This Book - (Show below) - (Hide below)

    CSA ISO 7207-1 : 0 IMPLANTS FOR SURGERY - FERMORAL AND TIBIAL COMPONENTS FOR PARTIAL AND TOTAL KNEE JOINT PROSTHESES - PART 1: CLASSIFICATION, DEFINITIONS AND DESIGNATION OF DIMENSIONS
    CSA ISO 8319-1 : 0 ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 1: KEYS FOR USE WITH SCREWS WITH HEXAGON SOCKET HEADS
    CSA ISO 8319-2 : 0 ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 2: SCREWDRIVERS FOR SINGLE SLOT HEAD SCREWS, SCREWS WITH CRUCIATE SLOT AND CROSS-RECESSED HEAD SCREWS
    CSA ISO 5833 : 0 IMPLANTS FOR SURGERY - ACRYLIC RESIN CEMENTS
    CSA ISO 5835 : 0 IMPLANTS FOR SURGERY - METAL BONE SCREWS WITH HEXAGONAL DRIVE CONNECTION, SPHERICAL UNDER-SURFACE OF HEAD, ASYMMETRICAL THREAD-DIMENSIONS
    CSA ISO 5832-2 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM
    CSA ISO 5832-4 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY
    CSA ISO 5832-3 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANDIUM ALLOY
    CSA ISO 5832-5 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 5: WROUGHT COBALT-CHROMIUM-TUNGSTEN-NICKEL ALLOY
    CSA ISO 7206-2 : 0 IMPLANTS FOR SURGERY - PARTIAL AND TOTAL HIP JOINT PROSTHESES - PART 2: ARTICULATING SURFACES MADE OF METALLIC, CERAMIC AND PLASTICS MATERIALS
    CSA ISO 5832-6 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 6: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM ALLOY

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

    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    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