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  • DIN EN 13544-1:2009-12

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  English

    Published date:  01-01-2009

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

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

    Vorwort
    Einleitung
    1 R) Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Allgemeine Anforderungen und allgemeine
       Anforderungen an 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 R) Bereiche und grundlegende Anforderungen
    38 R) Aufschriften, Begleitpapiere
    39 R) Gemeinsame Anforderungen an Geräte der
       Klassen AP und APG
    40 R) Anforderungen und Prüfungen für Geräte
       der Klasse AP, ihre Geräteteile und Bauteile
    41 R) Anforderungen und Prüfungen für Geräte der
       Klasse APG, ihre Geräteteile und Bauteile
    42 Übermässige Temperaturen
    43 R) Brandverhütung
    44 Überlaufen, Verschütten, Auslaufen, Feuchte,
       Eindringen von Flüssigkeiten, Reinigung, Sterilisation
       und Desinfektion
    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
    Anhang AA (informativ) Begründungen
    Anhang BB (informativ) Durchmesser des ablagerbaren
              Anteils der Partikel
    Anhang CC (normativ) Prüfverfahren für die Rate der
              Aerosolabgabe, die Aerosolabgabe und die
              Partikelgrösse
    Anhang DD (normativ) Überprüfungen der Massenbilanz
              bei Prüfungen mit Kaskaden-Aufprallsammlern
    Anhang EE (informativ) Umweltgesichtspunkte
    Anhang ZA (informativ) Zusammenhang zwischen dieser
              Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG
              über Medizinprodukte
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    Describes requirement for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    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
    ENV 737-6 : DRAFT 2003 MEDICAL GAS PIPELINE SYSTEMS - PART 6: DIMENSIONS AND ALLOCATION OF PROBES FOR TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
    ISO 9276-1:1998 Representation of results of particle size analysis — Part 1: Graphical representation
    DIN ISO 9276-1:2004-09 Representation of results of particle size analysis - Part 1: Graphical representation (ISO 9276-1:1998)
    EN ISO 10524-3:2006/A1:2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005/AMD 1:2013)
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    EN 61672-2:2013/A1:2017 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 2: PATTERN EVALUATION TESTS (IEC 61672-2:2013/A1:2017)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    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
    EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    EN 1281-2 : 1995 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    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 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
    EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    EN 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 3744:2010)
    EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
    EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
    ISO 9276-2:2014 Representation of results of particle size analysis Part 2: Calculation of average particle sizes/diameters and moments from particle size distributions
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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