SN EN 60601-2-43 : 2000

INTRODUCTION
SECTION 1: GENERAL
Clause
1 Scope and object
   1.1 Scope
   1.2 Object
   1.3 Particular standards
2 Terminology and definitions
6 Identification, marking and documents
   6.1 Marking on the outside of EQUIPMENT or
       EQUIPMENT parts
       6.8.2 INSTRUCTIONS FOR USE
       6.8.3 Technical description
       6.8.101 Statement of compliance
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
           EXCESSIVE RADIATION
29 X-RADIATION
    29.201.2 HALF-VALUE LAYERS in X-RAY EQUIPMENT
    29.201.4 FILTRATION in X-RAY SOURCE ASSEMBLIES
    29.203.4 Correspondence between X-RAY FIELD and
              IMAGE RECEPTION AREA
    29.208.3 Designated SIGNIFICANT ZONES OF OCCUPANCY
    29.208.101 Isokerma maps
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
           FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7 : PROTECTION AGAINST EXCESSIVE TEMPERATURES
            AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization and disinfection
    44.1 General
    44.6 Ingress of fluids
          44.6.101 Footswitches
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
           AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
    51.101 Control features
    51.102 Information to the OPERATOR
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
           ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
59 Construction and layout
    59.101 Configuration for cardiopulmonary
            resuscitation (CPR)
    59.102 Attachment of protective drapes
Annexes
L References - Publications mentioned in this
                standard
AA Terminology - Index of defined terms
BB Indications for the need to use EQUIPMENT
   complying with this standard
CC The INTERVENTIONAL REFERENCE POINT
DD Cleaning and disinfection
EE Procedure for measuring REFERENCE AIR KERMA (RATE)
FF Distribution maps of STRAY RADIATION
ZA (NORMATIVE) NORMATIVE REFERENCES TO INTERNATIONAL
               PUBLICATIONS WITH THEIR CORRESPONDING
               EUROPEAN PUBLICATIONS
ZB (INFORMATIVE) OTHER INTERNATIONAL PUBLICATIONS
                 MENTIONED IN THIS STANDARD WITH THE
                 REFERENCES OF THE RELEVANT EUROPEAN
                 PUBLICATIONS
Figures
101 Example of isokerma map at 100 cm height
102 Example of isokerma map at 150 cm height
Tables
101 Subclauses containing normative references to the
    ACCOMPANYING DOCUMENTS
102 Addition to Table Xa in IEC 60601-1
BB.1 Examples of prolonged RADIOSCOPICALLY GUIDED
     INTERVENTIONAL PROCEDURES for which deterministic
     effects of IRRADIATION are possible
BB.2 Examples of RADIOSCOPICALLY guided procedures
     for which deterministic effects are unlikely

Applicable to X-Ray equipment declared by the manufacturer to be suitable for prolonged radioscopically guided interventional procedures. Excludes in particular - equipment for RADIOTHERAPY, equipment for COMPUTED TOMOGRAPHY, ACCESSORIES intended to be introduced into the PATIENT, mammographic X-RAY EQUIPMENT.