• BS EN 13328-2:2002

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

    Available format(s): 

    Superseded date:  29-08-2008

    Language(s): 

    Published date:  04-02-2004

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 BSF port connectors
      4.1 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 method for gas leakage
    6 Requirements for BSFs supplied sterile
      6.1 Sterility assurance
      6.2 Packaging of BSFs supplied sterile
    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
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    Gives requirements for non-filtration aspects of breathing system filters (BSFs) intended for the filtration of respired gases in humans when used with a breathing system. It addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied.

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

    Committee CH/121/5
    Development Note Supersedes 00/563809 DC (12/2002)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    EN 1281-2 : 1995 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    EN ISO 9360-1:2009 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 9360-1:2000)
    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
    EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 13328-1 : 2001 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE
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