HD 395.2.7 : 200S1

FOREWORD
PREFACE
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - SAFETY REQUIREMENTS
8 Basic safety categories
9 Removable protective means
10 Special environmental conditions
11 Special measures with respect to safety
12 SINGLE FAULT CONDITION
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General
14 Requirements related to classification
15 Limitation of voltage and/or current
16 Enclosures and PROTECTIVE COVERS
17 Insulation and PROTECTIVE IMPEDANCES
18 Earthing and potential equalization
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
   CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability and transportability
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
               OR EXCESSIVE RADIATION
29 X-radiation
30 Alpha, beta, gamma, neutron radiation and other
   particle radiation
31 Microwave radiation
32 Light radiation (including visual radiation and lasers)
33 Infra-red radiation
34 Ultra-violet radiation
35 Acoustical energy (including ultra-sonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF EXPLOSIONS IN
              MEDICALLY USED ROOMS
37 General
38 Classification, marking and ACCOMPANYING DOCUMENTS of
   ANAESTHETIC-PROOF EQUIPMENT
39 Common requirements for "AP" and "APG" EQUIPMENT
40 Requirements and tests for ANAESTHETIC-PROOF EQUIPMENT,
   EQUIPMENT parts or components (AP)
41 Requirements and tests for ANAESTHETIC-PROOF CATEGORY G
   EQUIPMENT, EQUIPMENT parts or components
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES,
                FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORS
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
   cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Materials in APPLIED PARTS in contact with the body of
   the PATIENT
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST INCORRECT OUTPUT
50 Accuracy of operating data
51 Protection against incorrect output
SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR
               MECHANICAL DAMAGE, ENVIRONMENTAL TESTS
52 Fault conditions causing overheating and/or mechanical
   damage
53 Environmental tests
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
55 Enclosures and covers
56 Components and general assembly
57 MAINS PARTS, components and layout
58 PROTECTIVE EARTH TERMINALS
59 Construction and layout
Figures
Tables
APPENDIX AA - Values of the series R'10, ISO Standard 497
APPENDIX BB - Tables of combinations of LOADING FACTORS
              for tests
APPENDIX CC - Example for the determination of the combination
              of LOADING FACTORS according to sub-clause
              50.109 for tests for linearity and constancy
ALPHABETICAL INDEX

Applicable to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS that operate between 10 kV and 400 kV and in which the electric energy for LOADING an X-RAY TUBE is derived from alternating current SUPPLY MAINS without an essential element of energy storage within the equipment.