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    I.S. EN 60601-2-13:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-01-2013

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    INTRODUCTION
    SECTION ONE - GENERAL
      1 Scope and object
      2 Terminology and definitions
      3 General requirements
      4 General requirements for tests
      6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
      10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
                    HAZARDS
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM
                   UNWANTED OR EXCESSIVE RADIATION
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
                  OF FLAMMABLE ANAESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                    AND OTHER SAFETY HAZARDS
      43 Fire prevention
      44 Overflow, spillage, leakage, humidity, ingress of
          liquids, cleaning, sterilization and disinfection
      49 Interruption of the POWER SUPPLY
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                    AGAINST HAZARDOUS OUTPUT
      51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS
                   ENVIRONMENTAL TESTS
      52 Abnormal operation and fault conditions
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
      54 General
      56 Components and general assembly
      57 MAINS PARTS, components and layout
    SECTION 101 - ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC
                  GAS DELIVERY SYSTEMS
      101 Medical gas supply
      102 Medical gas pipeline inlet connections
      103 Medical gas supply pressure monitoring
      104 Medical gas supply PRESSURE REGULATORs
      105 Anaesthetic gas delivery system piping
      106 Gas flow metering
      107 Gas mixer
      108 Oxygen flush
      109 Fresh gas outlet
      110 Checklist
    Annex AA (informative) Guidance and rationale for
             particular clauses and subclauses in this
             particular standard
    Annex BB (informative) MONITORING DEVICES, ALARM
             SYSTEM(S) and PROTECTION DEVICES
    Annex CC (informative) Separate devices of an ANAESTHETIC
             SYSTEM
    Annex DD (normative) Test for flammability of anaesthetic
             agent
    Annex EE (informative) Clauses of this International
             Standard Addressing the essential requirements
             or other provisions of EU directives
    Bibliography
    Index of defined terms
    Annex ZA (normative) Normative references to international
             publications with their corresponding European
             publications

    Abstract - (Show below) - (Hide below)

    Specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM as well as individual devices designed for use in an ANAESTHETIC SYSTEM.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
    ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 9703-3:1998 Anaesthesia and respiratory care alarm signals Part 3: Guidance on application of alarms
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    ISO 9918:1993 Capnometers for use with humans Requirements
    ISO 5145:2014 Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 5362:2006 Anaesthetic reservoir bags
    IEC 60079-11:2011 Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i"
    ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    ISO 10524:1995 Pressure regulators and pressure regulators with flow-metering devices for medical gas systems
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
    ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
    ISO 8835-4:2004 Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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