Skip to content
Please enter a keyword to search

  • BS EN ISO 8836:2014

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Suction catheters for use in the respiratory tract

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-10-2020

    Language(s):  English

    Published date:  30-11-2014

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements for open and closed
       suction catheters
    5 Specific requirements for open and closed
       suction catheters
    6 Materials
    7 Design
    8 Performance requirements
    9 Requirements for suction catheters supplied
       sterile
    10 Marking
    Annex A (informative) - Rationale
    Annex B (normative) - Test method for security of
            attachment
    Annex C (normative) - Measurement of residual vacuum
    Annex D (normative) - Method of testing leakage
    Annex E (informative) - Hazard identification for risk
            assessment
    Bibliography
    Annex ZA (informative) - Relationship between
             this European Standard and the
             Essential Requirements of EU
             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Describes requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.

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

    Committee CH/121/5
    Development Note Supersedes BS EN 1733, 04/30109833 DC and 05/30138123 DC. (09/2008)
    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    Status Superseded
    Superseded By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 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    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
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    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
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
    ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 5366-3:2001 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
    ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    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 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
    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