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  • CSA ISO 7199 : 0

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  23-06-2005

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements
    5 Tests and measurements to determine compliance
       with this International Standard
    6 Information supplied by the manufacturer
    7 Packaging
    Annex A (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Requirements for sterile, single-use, extracorporeal blood-gas exhangers (oxygenators) intended to supply oxygen to, and remove carbon dioxide from, human blood are defined in this standard. Also applicable to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.

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    Development Note Supersedes CSA Z364.3. (08/2000)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn
    Superseded By
    Supersedes

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

    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 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    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 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 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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