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  • DIN EN ISO 10651-6:2011-06

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  English

    Published date:  01-01-2011

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

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

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Allgemeine Anforderungen und Allgemeines
        über die Prüfungen
    5 Klassifikation
    6 Bezeichnungen, Aufschriften und Begleitpapiere
    7 Strom- bzw. Leistungsaufnahme
    8 Grundlegende Sicherheitsanforderungen
    9 Abnehmbare Schutzvorrichtungen
    10 Umweltbedingungen
    11 Nicht benutzt
    12 Nicht benutzt
    13 Allgemeines
    14 Anforderungen in Bezug auf die Einteilung der
        Geräte
    15 Begrenzung von Spannung und/oder Energie
    16 Gehäuse und Schutzabdeckungen
    17 Trennung
    18 Schutzleiteranschluss, Betriebserdung und
        Potenzialausgleich
    19 Dauer-Ableit- und Patientenhilfsströme
    20 Spannungsfestigkeit
    21 Mechanische Festigkeit
    22 Bewegte Teile
    23 Oberflächen, Ecken und Kanten
    24 Standfestigkeit bei bestimmungsgemässem
        Gebrauch
    25 Herausgeschleuderte Teile
    26 Erschütterungen und Geräusche
    27 Pneumatische und hydraulische Energie
    28 Aufgehängte Massen
    29 Röntgenstrahlung
    30 Alpha-, Beta-, Gamma- und Neutronenstrahlung
        sowie sonstige Korpuskularstrahlung
    31 Mikrowellenstrahlung
    32 Lichtstrahlung (einschliesslich Laserstrahlen)
    33 Infrarotstrahlung
    34 Ultraviolett-Strahlung
    35 Schallenergie (einschliesslich Ultraschall)
    36 Elektromagnetische Verträglichkeit
    37 Bereiche und grundlegende Anforderungen
    38 Aufschriften, Begleitpapiere
    39 Gemeinsame Anforderungen an Geräte der
        Klassen AP und APG
    40 Anforderungen und Prüfungen für Geräte
        der Klasse AP, ihre Geräteteile und Bauteile
    41 Anforderungen und Prüfungen für Geräte der
        Klasse APG, ihre Geräteteile und Bauteile
    42 Übermässige Temperaturen
    43 Brandverhütung
    44 Überlaufen, Verschütten, Auslaufen, Feuchte,
        Eindringen von Flüssigkeiten, Reinigung,
    Sterilisation, Desinfektion und Verträglichkeit
    45 Druckbehälter und durch Druck beanspruchte Teile
    46 Menschliches Versagen
    47 Elektrostatische Aufladungen
    48 Bioverträglichkeit
    49 Unterbrechung der Stromversorgung
    50 Genauigkeit der Betriebsdaten
    51 Schutz gegen gefährdende Ausgangswerte
    52 Nichtbestimmungsgemässer Betrieb und
        Fehlerfälle
    53 Umweltprüfungen
    54 Allgemeines
    55 Gehäuse und Abdeckungen
    56 Bauteile und Allgemeines zum Zusammenbau
    57 Netzteile, Bauteile und Ausführung
    58 Schutzleiter - Klemmen und Verbindungen
    59 Aufbau und Anordnung
    101 Alarmsysteme
    102 Anhänge von IEC 60601-1:1998
    Anhang AA (informativ) Begründungen
    Anhang BB (informativ) Verweisung auf die
              grundlegenden Anforderungen
    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen
              dieser Europäischen Norm und den
              grundlegenden Anforderungen der EG-Richtlinie
              93/42/EWG

    Abstract - (Show below) - (Hide below)

    Defines the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required.

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

    Development Note Supersedes DIN EN 794-2. (10/2004)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN EN ISO 80601-2-72:2016-04 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 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

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

    ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
    ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
    ISO 10241:1992 International terminology standards Preparation and layout
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    DIN EN 60601-1-1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    DIN EN ISO 18777:2009-07 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    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
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    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
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
    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
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    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 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 5362:2006 Anaesthetic reservoir bags
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    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
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
    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
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    DIN EN ISO 8359:2009-08 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS
    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 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    VDE 0750-1-1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    VDE 0750-1-4 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY; COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 13014:2000/AC:2002 CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
    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)
    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
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    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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