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    I.S. EN ISO 80601-2-72:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)

    Available format(s):  Hardcopy, PDF

    Superseded date:  18-12-2023

    Language(s):  English

    Published date:  01-01-2015

    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)

    National Foreword
    European foreword
    Foreword
    Introduction
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of
            ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT
            and ME SYSTEMS
    201.7 ME EQUIPMENT identification,
            marking and documents
    201.8 Protection against electrical HAZARDS
            from ME EQUIPMENT
    201.9 Protection against mechanical HAZARDS
            of ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive
            radiation HAZARDS
    201.11 Protection against excessive temperatures
            and other HAZARDS
    201.12 Accuracy of controls and instruments and
            protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault
            Conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL
            SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME
            EQUIPMENT and ME SYSTEMS
    201.101 Gas connections
    201.102 Requirements for the VBS and
            ACCESSORIES
    201.103 Spontaneous breathing during loss
            of power supply
    201.104 Training
    201.105 Indication of duration of operation
    201.106 FUNCTIONAL CONNECTION
    201.107 Display loops
    201.108 POWER SUPPLY CORDS
    201.109 VENTILATOR security
    202 Electromagnetic disturbances - Requirements
        and tests
    206 Usability
    208 General requirements, tests and guidance for alarm
        systems in medical electrical equipment and
        medical electrical systems
    211 Requirements for medical electrical equipment
        and medical electrical systems used in the home
        healthcare environment
    Annex C (informative) - Guide to marking and
            labelling requirements for ME EQUIPMENT
            and ME SYSTEMS
    Annex D (informative) - Symbols on marking
    Annex AA (informative) - Particular guidance
             and rationale
    Annex BB (informative) - Data interface requirements
    Annex CC (informative) - Reference to the Essential
             Principles
    Annex DD (informative) - Alphabetized index of
             defined terms used in this particular standard
    Bibliography
    Annex ZA (informative) - Relationship between this
             Document and the Essential Requirements of
             EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Pertains to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: - intended for use in the home healthcare environment; - intended for use by a lay operator; and - intended for use with patients who are dependent on mechanical ventilation for their life support.

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

    Development Note Supersedes I.S. EN ISO 10651-2. (10/2015)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    IEC 60038:2009 IEC standard voltages
    ISO 8836:2014 Suction catheters for use in the respiratory tract
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    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
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    CFR 45(PTS1-199) : OCT 2017 PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    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
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    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/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
    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
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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