• I.S. EN 60601-2-12:2006

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS

    Available format(s):  Hardcopy, PDF

    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
      5 Classification
      6 Identification, marking and documents
      7 Power input
    SECTION TWO - ENVIRONMENTAL CONDITIONS
      8 Basic safety categories
      9 Removable protective means
      10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
      13 General
      14 Requirements related to classification
      15 Limitation of voltage and/or energy
      16 ENCLOSURES and PROTECTIVE COVERS
      17 Separation
      18 Protective earthing, functional earthing and potential
         equalization
      19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
      20 Dielectric strength
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
      21 Mechanical strength
      22 Moving parts
      23 Surfaces, corners and edges
      24 Stability in NORMAL USE
      25 Expelled parts
      26 Vibration and noise
      27 Pneumatic and hydraulic power
      28 Suspended masses
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
      29 X-radiation
      30 Alpha, beta, gamma, neutron radiation and other particle
         radiation
      31 Microwave radiation
      32 Light radiation (including lasers)
      33 Infra-red radiation
      34 Ultra-violet radiation
      35 Acoustical energy (including ultrasonics)
      36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
                  ANAESTHETIC MIXTURES
      37 Locations and basic requirements
      38 Marking, ACCOMPANYING DOCUMENTS
      39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT
      40 Requirements and tests for CATEGORY AP EQUIPMENT, parts
         and components thereof
      41 Requirements and tests for CATEGORY APG EQUIPMENT, parts
         and components thereof
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
                    OTHER SAFETY HAZARDS
      42 Excessive temperatures
      43 Fire prevention
      44 Overflow, spillage, leakage, humidity, ingress of liquids,
         cleaning, sterilization, disinfection and compatibility
      45 Pressure vessels and parts subject to pressure
      46 Human errors
      47 Electrostatic charges
      48 Biocompatibility
      49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATAAND PROTECTION
                    AGAINST HAZARDOUS OUTPUT
      50 Accuracy of operating data
      51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
                   ENVIRONMENTAL TESTS
      52 Abnormal operation and fault conditions
      53 Environmental tests
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
      54 General
      55 ENCLOSURES and covers
      56 Components and general assembly
      57 MAINS PARTS, components and layout
      58 Protective earthing - Terminals and connections
      59 Construction and layout
    Appendix L References - Publications mentioned in this standard
    Annex AA (informative) Rationale
    Annex BB (normative) Legibility and visibility of visual indications
    Annex CC (informative) Intelligent alarm systems
    Annex ZA (normative) Normative references to international
             publications with their corresponding European publications
    Annex ZB (informative) References to international publications
             with their corresponding European publications
    Annex ZZ (informative) Coverage of Essential Requirements
             of EC Directives
    Bibliography
    Terminology - Index of defined terms

    Abstract - (Show below) - (Hide below)

    Describes the safety requirements for VENTILATORS, as defined in 2.1.125, intended for use in critical care settings.

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

    Development Note Supersedes I.S. EN 794-1. (07/2008) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
    ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
    IEC 60416:1988 General principles for the formulation of graphical symbols
    IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
    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
    ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 9918:1993 Capnometers for use with humans Requirements
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 5362:2006 Anaesthetic reservoir bags
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO 7396:1987 Non-flammable medical gas pipeline systems
    IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    IEC 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    IEEE DRAFT 1073 : D3.6 SEP 95 STANDARD FOR MEDICAL DEVICE COMMUNICATIONS OVERVIEW AND FRAMEWORK
    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 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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