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  • CSA ISO 11712 : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-06-2019

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Requirements
    6 Requirements for supralaryngeal airways and connectors
      supplied sterile
    7 Cleaning and disinfection or sterilization
    8 Markings
    9 Accompanying documents
    Annex A (informative) - Rationale
    Annex B (normative) - Evaluation and documentation of the
            clinical performance in human subjects
    Annex C (normative) - Test methods to determine kink resistance
    Annex D (informative) - Hazard identification for risk assessment
    Annex E (informative) - Guidance on materials and design
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the essential requirements for the design of supralaryngeal airways and connectors.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By

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

    ISO 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
    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
    ASTM F 2560 : 2006 Standard Specification for Supralaryngeal Airways and Connectors
    ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    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 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO/TS 16628:2003 Tracheobronchial tubes Recommendations for size designation and labelling
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 11990:2003 Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO/TS 15843:2000 Sterilization of health care products Radiation sterilization Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    AAMI TIR20 : 2001 PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
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