SN EN 60601-2-1 : 1998

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

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