• DIN EN 60601-2-2 : 2010

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES

    Available format(s): 

    Superseded date:  16-11-2022

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Verband Deutscher Elektrotechniker

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

    INTRODUCTION
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    4 General requirements for tests
    5 Classification
    6 Identification, marking and documents
    7 Power input
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    SECTION THREE - PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
    14 Requirements related to classification
    17 Separation
    18 Protective earthing, functional earthing and potential
       equalization
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
    20 Dielectric strength
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
    36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
                  FLAMMABLE ANAESTHETIC MIXTURES
    39 Common requirements for CATEGORY AP and CATEGORY APG
       EQUIPMENT
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                    AND OTHER SAFETY HAZARDS
    42 Excessive temperatures
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
       cleaning, sterilization, disinfection and compatibility
    46 Human errors
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                    AGAINST HAZARDOUS OUTPUT
    50 Accuracy of operating data
    51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
                   ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    56 Components and general assembly
    59 Construction and layout
    Appendix L References - Publications mentioned in this standard
    Annex AA (informative) - Guidance and rationale for particular
             clauses and subclauses
    Annex BB (informative) - Electromagnetic disturbances created
             by HF SURGICAL EQUIPMENT
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EC Directives

    Abstract - (Show below) - (Hide below)

    Diese Norm spezifiziert besondere Festlegungen für die Basissicherheit einschliesslich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten und HF-chirurgischem Zubehör und ergänzt die DIN EN 60601-1 (VDE 0750-1):2007-07.

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

    Development Note Supersedes DIN IEC 60601-2-2. (07/2004) Applies in conjunction with DIN EN 60601-1 issue 07-2007. (03/2008) DRAFT 2016 issued in March 2016. (04/2016)
    Document Type Standard
    Publisher Verband Deutscher Elektrotechniker
    Status Superseded
    Superseded By
    Supersedes

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

    DIN EN 60601-2-30 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
    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 80601-2-72 E : 2016 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)
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