• DIN EN 60601-2-30 : 2000

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

    Available format(s): 

    Superseded date:  01-05-2011

    Language(s): 

    Published date:  12-01-2013

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

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

    Vorwort
    Einleitung
    HAUPTABSCHNITT EINS - ALLGEMEINES
    1 Anwendungsbereich und Zweck
    2 Begriffe und Definitionen
    3 Allgemeine Anforderungen
    4 Allgemeines über die Prüfungen
    5 Klassifikation
    6 Bezeichnungen, Aufschriften und Begleitpapiere
    HAUPTABSCHNITT ZWEI - UMWELTBEDINGUNGEN
    HAUPTABSCHNITT DREI - SCHUTZ GEGEN DIE GEFAHR EINES
    ELEKTRISCHEN SCHLAGES
    14 Anforderungen in Bezug auf die Einteilung der Geräte
    17 Trennung
    19 Dauer-Ableit- und Patientenhilfsströme
    20 Spannungsfestigkeit
    HAUPTABSCHNITT VIER - SCHUTZ GEGEN MECHANISCHE GEFÄHRDUNG
    21 Mechanische Festigkeit
    22 Bewegte Teile
    HAUPTABSCHNITT FÜNF - SCHUTZ GEGEN GEFAHREN DURCH UNERWÜNSCHTE
    ODER ÜBERMÄSSIGE STRAHLUNG
    36 Elektromagnetische Verträglichkeit
    HAUPTABSCHNITT SECHS - SCHUTZ GEGEN GEFAHREN DURCH ZÜNDUNG
    BRENNBARER GEMISCHE
    HAUPTABSCHNITT SIEBEN - SCHUTZ GEGEN ÜBERMÄSSIGE TEMPERATUREN
    UND ANDERE GEFÄHRDUNGEN
    42 Übermässige Temperaturen
    44 Überlaufen, Verschütten, Auslaufen, Feuchte, Eindringen
       von Flüssigkeit, Reinigung, Sterilisation und Desinfektion
    45 Druckbehälter und durch Druck beanspruchte Teile
    49 Unterbrechung der Stromversorgung
    HAUPTABSCHNITT ACHT - GENAUIGKEIT DER BETRIEBSDATEN UND
    SCHUTZ GEGEN GEFÄHRDENDE AUSGANGSWERTE
    50 Genauigkeit der Betriebsdaten
    51 Schutz gegen gefährdende Ausgangswerte
    HAUPTABSCHNITT NEUN - NICHT BESTIMMUNGSGEMÄSSER BETRIEB
    UND FEHLERFÄLLE; UMWELTPRÜFUNGEN
    HAUPTABSCHNITT ZEHN - KONSTRUKTIVE ANFORDERUNGEN
    56 Bauelemente und Allgemeines zum Zusammenbau
    57 Netzteile, Bauteile und Ausführung
    Anhang L (normativ) Schriftstücke, auf die in dieser Norm
              Bezug genommen wird
    Anhang AA (informativ) Allgemeine Erklärung und Begründung
    Anhang BB (informativ) Alarm-Diagramme
    Anhang ZA (normativ) Normative Verweisungen auf Internationale
              Publikationen mit ihren entsprechenden Europäischen
              Publikationen
    Anhang ZB (informativ) Andere in dieser Norm zitierte
              internationale Publikationen mit den Verweisungen auf
              die entsprechenden europäischen Publikationen

    Abstract - (Show below) - (Hide below)

    Specifies criteria for safety and essential performance of AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT, (referred to as equipment). The equipment may be attended or unattended. Does not apply to blood pressure measuring equipment which uses finger transducers or to semi-automatic blood pressure measuring equipment, where each determination typically needs to be initiated manually.

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

    Development Note Supersedes DIN IEC 62D-289-CDV. (03/2003)
    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 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    HD 395.2.2 : 200S1 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY SURGICAL EQUIPMENT
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    VDE 0847-4-6 : 2014 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
    DIN VDE 0470-1 : 1992
    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)
    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
    VDE 0847-4-8 : 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    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
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    DIN EN 61000-4-6 : 2014 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    EN 61000-4-8:2010 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    DIN EN 61000-4-3 : 2011 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    DIN EN 61000-4-8 : 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    EN 61000-4-6:2014/AC:2015 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    VDE 0750-1-4 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY; COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    VDE 0847-4-3 : 2011 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    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 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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