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  • DIN EN ISO 80601-2-72:2016-04

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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    Superseded date:  01-12-2023

    Language(s):  German, English

    Published date:  01-04-2016

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

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    Development Note Supersedes DIN EN ISO 10651-2. DIN EN ISO 10651-2 issue 06-2011 remains valid alongside this standard until 30-09-2018. Applies in conjunction with DIN EN 60601-1 issue 12-2013. (05/2016)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    VDE 0750-1-3 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013)
    DIN ISO 7000:2008-12 Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750)
    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
    DIN EN ISO 15223-1:2015-08 (Draft) MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
    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
    DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    DIN EN 61672-1:2014-07 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
    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
    DIN EN ISO 10651-4:2009-08 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
    DIN EN ISO 10651-6:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    DIN EN 60601-1-3 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013)
    DIN EN 60601-2-2 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES
    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
    DIN EN 60601-1-6 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010 + A1:2013)
    VDE 0750-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
    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
    DIN EN ISO 17664:2016-06 (Draft) PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
    VDE 0750-2-2 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES
    DIN EN 62366 : 2016 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
    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
    VDE 0750-101 : 2016 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    VDE 0750-1-6 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010 + A1:2013)
    DIN EN ISO 3744:2011-02 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 3744:2010)
    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
    DIN EN 60721-3-7:1995-09 CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE
    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
    VDE 0750-241 : 2016 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
    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
    DIN EN ISO 5356-1:2015-06 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015)
    DIN EN ISO 80369-2:2015-09 (Draft) SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS (ISO/DIS 80369-2:2015)
    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
    DIN EN ISO 80601-2-55 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2011)
    DIN EN 20594-1:1995-01 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
    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
    DIN EN ISO 5356-2:2013-03 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012)
    DIN EN 62304 : 2016 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    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
    DIN EN ISO 10524-1:2006-05 PRESSURE REGULATORS FOR USE WITH MEDICAL GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
    DIN EN ISO 14159:2008-07 SAFETY OF MACHINERY - HYGIENE REQUIREMENTS FOR THE DESIGN OF MACHINERY
    DIN EN ISO 5367:2015-02 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    DIN EN ISO 80369-1:2015-09 (Draft) SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
    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
    DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
    DIN EN ISO 7010:2012-10 GRAPHISCHE SYMBOLE - SICHERHEITSFARBEN UND SICHERHEITSZEICHEN - REGISTRIERTE SICHERHEITSZEICHEN (ISO 7010:2011/AMD 5:2014)
    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
    VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
    VDE 0750-1-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
    VDE 0750-2-55 : 2012 MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-55: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON UEBERWACHUNGSGERAETEN FUER ATEMGASE (ISO 80601-2-55:2011)
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    VDE 0750-2-12 : 2012 MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-12: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON BEATMUNGSGERAETEN FUER DIE INTENSIVPFLEGE (ISO/IEC 80601-2-12:2011 + COR.:2011)
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
    DIN EN 60601-1-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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