• SN EN 60601-2-1 : 1998

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRON ACCELERATORS IN THE RANGE OF 1 MEV TO 50 MEV

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    Withdrawn date:  15-09-2018

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Swiss Standards

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

    INTRODUCTION
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    4 General requirements for tests
    5 Classification
    6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    16 Enclosures and protective covers
    18 Protective earthing, functional earthing and potential
        equalization
    19 Continuous leakage currents and patient auxiliary
        currents
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    16 Enclosures and protective covers
    18 Protective earthing, functional earthing and potential
        equalization
    19 Continuous leakage currents and patient auxiliary currents
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    22 Moving parts
    27 Pneumatic and hydraulic power
    28 Suspended masses
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
    EXCESSIVE RADIATION
    29 X-Radiation
    29 Ionizing radiation safety requirements
        29.1 Protection against incorrect absorbed dose in
              the treatment volume
              29.1.1 Monitoring and control of absorbed dose
                      29.1.1.1 Dose monitoring systems
                      29.1.1.2 Radiation detectors
                      29.1.1.3 Selection and display of dose
                                monitor units
                      29.1.1.4 Termination of irradiation by the
                                dose monitoring system
                      29.1.1.5 Monitoring of distribution of
                                absorbed dose
              29.1.2 Controlling timer
              29.1.3 Absorbed dose rate
              29.1.4 Selection and display of radiation type
              29.1.5 Selection and display of energy
              29.1.6 Selection and display of stationary
                      radiotherapy and moving beam radiotherapy
              29.1.7 Radiation beam production and distribution
                      system
                      29.1.7.1 Selection and display of targets
                                or other movable radiation beam
                                production devices
                      29.1.7.2 Selection and display of field
                                flattening and beam scattering
                                filters
                      29.1.7.3 Radiation beam distribution systems
                                not using field flattening or
                                beam scattering filters
              29.1.8 Selection and display of wedge filters
              29.1.9 Electron beam applicators and trays for
                      the treatment volume
              29.1.10 Control of equipment use
              29.1.11 Starting conditions
              29.1.12 Interruption of irradiation
              29.1.14 Abnormal termination of irradiation
              29.1.15 Programmable electronic subsystems
        29.2 Protection against stray radiation in the
              radiation field
              29.2.1 Stray X-radiation in the radiation field
              29.2.2 Relative surface dose during X-irradiation
              29.2.3 Stray neutron radiation
        29.3 Protection against radiation in the patient plane
              outside the radiation field
              29.3.1 Leakage radiation through beam limiting
                      devices
                      29.3.1.1 X-radiation
                      29.3.1.2 Electron radiation
              29.3.2 Leakage radiation (excluding neutrons)
                      outside the area M
              29.3.3 Leakage neutron radiation outside the area
                      M
              29.3.4 Leakage radiation under fault conditions
        29.4 Radiation safety for patients and others
              29.4.1 Leakage X-radiation outside the patient
                      plane
              29.4.2 Leakage neutron radiation outside the
                      patient plane
              29.4.3 Emission of ionizing radiation after
                      termination of irradiation
              29.4.4 Retractable radiation beam shield
              29.4.5 Adventitious ionizing radiation
    36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
    FLAMMABLE ANAESTHETIC MIXTURES
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
    ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    57 Mains parts, components and layout
    Appendix L (normative) References - Publications mentioned
    in this standard
    Annex AA (informative) Terminology - Index of defined terms
    Annex BB (informative) Bibliography
    Annex ZA Normative references to international publications
              with their corresponding European publications
    Figure 101 Limits of stray X-radiation during electron
    irradiation (29.2.1)
    Figure 102 Limits of relative surface dose during
    X-irradiation (29.2.2)
    Figure 103 Elevation view - Application of leakage
    radiation requirements (29.3 1n3 29.4)
    Figure 104 24 measurement points for averaging leakage
    leakage radiation during X-irradiation (29.3.1.2)
    Figure 105 Limits of leakage radiation through the beam
    limiting devices during electron irradiation (29.3.1.2)
    Figure 106 Measurement points for averaging leakage
    radiation during electron irradiation (29.3.1.2)
    Figure 107 24 measurement points for averaging leakage
    radiation outside area M (29.3.2)
    Figure 108 Equipment movements and scales
    Table 101 Data required in the technical description to
    support clause 29 site test compliance
    Table 102 Clauses and subclauses in this Particular
    Standard that require the provision of information in the
    accompanying documents, instructions for use and the
    technical description
    Table 103 Limits of stray X-radiation during electron
    irradiation
    Table 104 Limits of relative surface dose due to
    X-irradiation

    Abstract - (Show below) - (Hide below)

    Applicable to the manufacture and some installation aspects of electron accelerators.

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

    Document Type Standard
    Publisher Swiss Standards
    Status Withdrawn
    Superseded By
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