Skip to content
Please enter a keyword to search

  • DIN EN ISO 23328-2 E : 2009

    Current The latest, up-to-date edition.

    BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

    Add To Cart

    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
    National Annex NA (informative) - Bibliography

    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.

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

    Development Note Supersedes DIN EN 13328-2 E. (08/2008)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 80601-2-72 E : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    DIN EN ISO 5367 E : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)

    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
    DIN EN ISO 9360-1 E : 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 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
    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