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