SN EN 60601-2-11 : 1997

Foreword
Introduction
Section 1. General
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
Section 2. Environmental conditions
10 Environmental conditions
Section 3. 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
20 Dielectric strength
Section 4. Protection against mechanical hazards
21 Mechanical strength
22 Moving parts
27 Pneumatic and hydraulic power
28 Suspended masses
Section 5. Protection against hazards from unwanted or
            excessive radiation
29 RADIATION safety requirements
   29.1 Protection of the PATIENT against incorrect ABSORBED
        DOSE in the TREATMENT VOLUME
        29.1.1 SOURCE CARRIER or SHUTTER
        29.1.2 BEAM OFF and BEAM ON conditions
        29.1.3 Control of IRRADIATION
        29.1.4 STATIONARY RADIOTHERAPY and MOVING BEAM
                RADIOTHERAPY
        29.1.5 Beam distributing systems
        29.1.6 WEDGE FILTERS
        29.1.7 BEAM APPLICATORS
        29.1.8 Facilities for starting IRRADIATION
        29.1.9 Facilities for INTERRUPTION OF IRRADIATION
        29.1.10 Facilities for TERMINATION OF IRRADIATION
        29.1.11 Unplanned TERMINATION OF IRRADIATION
        29.1.12 Facilities for checking INTERLOCK systems
   29.2 Protection of the PATIENT against STRAY RADIATION in
        the RADIATION BEAM
        29.2.1 RELATIVE SURFACE DOSE
   29.3 Protection of the PATIENT against RADIATION outside
        the RADIATION BEAM
        29.3.1 LEAKAGE RADIATION through BEAM LIMITING DEVICES
                during IRRADIATION
        29.3.2 LEAKAGE RADIATION outside the maximum RADIATION
                BEAM
   29.4 RADIATION safety for persons other than PATIENTS
        29.4.1 Indication of BEAM OFF and BEAM ON conditions
        29.4.2 STRAY RADIATION in the BEAM OFF condition
        29.4.3 Safety in setting operating states
        29.4.4 RADIATION SOURCE and RADIATION HEAD
        29.4.5 Radioactive materials used in the construction
                of the EQUIPMENT
        29.4.6 Environmental protection
Section 6. Protection against hazards of ignition of flammable
            anaesthetic mixtures
Section 7. Protection against excessive temperatures and other
            safety hazards
Section 8. Accuracy of operating data and protection against
            hazardous output
Section 9. Abnormal operation and fault conditions; environmental
            tests
Section 10. Constructional requirements
57 MAINS PARTS, components and layout
Appendix L References - Publications mentioned in this standard
Annex AA (informative) Index of terms
Annex ZA (normative) Normative references to international
                     publications with their corresponding
                     European publications

Defines requirements for the safety of gamma beam therapy equipment for radiotherapy in human medical practice, including equipment in which the selection and display of operating parameters is controlled by a programmable electronic system (PES).