• BS EN ISO 23328-2:2009

    Current The latest, up-to-date edition.

    Breathing system filters for anaesthetic and respiratory use Non-filtration aspects

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-04-2009

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 BSF port connectors
      4.1 BSF breathing system and patient connection
          ports
      4.2 Accessory ports
    5 Test methods
      5.1 Ambient conditions of test
      5.2 Measurement of pressure drop
      5.3 Test for gas leakage
    6 Packaging of sterile BSF
    7 Marking
      7.1 Use of symbols
      7.2 Marking of BSF
      7.3 Marking of package
      7.4 BSF intended for single use
    8 Information to be provided by the manufacturer
    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 non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied.

    Scope - (Show below) - (Hide below)

    This part of ISO23328 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system.

    It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements.

    NOTE A method for assessing filtration performance of BSF is given in ISO23328-1.

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

    Committee CH/121/5
    Development Note Supersedes BS EN 13328-2 and 07/30167200 DC. (09/2008) Supersedes 08/30191694 DC. (04/2009)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    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 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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