FOREWORD
PREFACE
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
2.1 EQUIPMENT parts, auxiliaries and accessories
2.2 EQUIPMENT types (classification)
2.3 Insulation
2.4 Voltages
2.5 Currents
2.6 Earth terminals and conductors
2.7 Connection (devices)
2.8 Transformers
2.9 Controls and limiting devices
2.10 Operation of EQUIPMENT
2.11 Mechanical safety
2.12 Miscellaneous
3 General requirements
4 General requirements for tests
4.1 Type tests and routine tests
4.2 Repetition of tests
4.3 Number of samples
4.4 Components
4.5 Ambient temperature, humidity, atmospheric
pressure
4.6 Other conditions
4.7 Supply and test voltages, type of current,
nature of supply, frequency
4.8 Preconditioning
4.9 Repairs and modifications
4.10 Moisture preconditioning treatment
4.11 Sequence
5 Classification
6 Identification, marking and documents
6.1 Marking on the outside of MAINS OPERATED EQUIPMENT
or EQUIPMENT parts and on the outside of EQUIPMENT
or EQUIPMENT parts without direct SUPPLY MAINS
connection, including EQUIPMENT supplied by and
INTERNAL ELECTRICAL POWER SOURCE
6.2 Marking on the inside of EQUIPMENT or EQUIPMENT
parts
6.3 Marking of controls
6.4 Symbols
6.5 Colours of the insulation of conductors
6.6 Identification of medical gas cylinders and
connections
6.7 Indicator lights and push-buttons
6.8 ACCOMPANYING DOCUMENTS
7 Power input
SECTION TWO - SAFETY REQUIREMENTS
INTRODUCTION
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
14.1 CLASS 1 EQUIPMENT
14.2 CLASS 2 EQUIPMENT
14.3 CLASS 3 EQUIPMENT
14.4 CLASS 1, 2 AND 3 EQUIPMENT
14.5 EQUIPMENT with an INTERNAL ELECTRICAL POWER
SOURCE
14.6 TYPES B, BF and CF EQUIPMENT
14.7 Test specification
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
19.1 General requirements
19.2 SINGLE FAULT CONDITIONS
19.3 ALLOWABLE VALUES
19.4 Testing
20 Dielectric strength
20.1 General requirements
20.2 Particular requirements for EQUIPMENT with an
APPLIED PART
20.3 Values of test voltages
20.4 Tests
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
28.1 General
28.2 Definition
28.3 Safety devices
28.4 Suspension systems without safety devices
28.5 Dynamic loads
28.6 Test specification
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
INTRODUCTION
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
INTRODUCTION
37 General
38 Classification, marking and ACCOMPANYING DOCUMENTS
OF ANAESTHETIC-PROOF EQUIPMENT
39 Common requirements for 'AP' and 'APG' EQUIPMENT
39.1 Supply connections and other electrical
connections
39.2 Construction details
39.3 Prevention of electrostatic charges
40 Requirements and tests for ANAESTHETIC-PROOF EQUIPMENT,
EQUIPMENT parts or components (AP)
40.1 General
40.2 Temperature limits
40.3 Low-energy circuits
40.4 External ventilation with internal overpressure
40.5 Enclosures with restricted breathing
41 Requirements and test for ANAESTHETIC-PROOF CATEGORY G
EQUIPMENT, EQUIPMENT parts of 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
44.1 General
44.2 Overflow
44.3 Spillage
44.4 Leakage
44.5 Humidity
44.6 Ingress of liquids
44.7 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
54.1 Arrangement of functions
54.2 Serviceability
54.3 Inadvertent changing of settings
55 Enclosures and covers
55.1 Materials
55.2 Mechanical strength
55.3 ACCESS COVERS
55.4 Grips and other handling devices
56 Components and general assembly
56.1 General
56.2 Screws and nuts
56.3 Terminals and connectors - General
56.4 Connection of capacitors to ACCESSIBLE
CONDUCTIVE PARTS, etc
56.5 PROTECTIVE DEVICES
56.6 Temperature control devices
56.7 INTERNAL ELECTRICAL POWER SOURCE
56.8 Indicators
56.9 Pre-set controls
56.10 Actuating parts of controls
56.11 Switches
57 MAINS PARTS, components and layout
57.1 Separation from SUPPLY MAINS
57.2 MAINS CONNECTORS AND APPLIANCE INLETS
57.3 Mains supply cables or cords
57.4 Connection of mains supply cables or cords
57.5 MAINS TERMINAL DEVICES and wiring
57.6 Mains fuses and OVER-CURRENT RELEASES
57.7 Location of interference suppressors in the
MAINS PART
57.8 Wiring of MAINS PART
57.9 Mains supply transformers and MEDICAL ISOLATING
TRANSFORMERS
57.10 CREEPAGE DISTANCES and AIR CLEARANCES
58 PROTECTIVE EARTH TERMINALS
59 Construction and layout
59.1 Internal wiring
59.2 Insulation
59.3 Excessive current and voltage protection
59.4 Oil containers
FIGURES 1 TO 50
APPENDIX A - Survey of medical electrical EQUIPMENT
APPENDIX B - Testing during manufacture and/or
installation
APPENDIX C - Sequence of testing
APPENDIX D - Symbols on marking
APPENDIX E - Survey of insulation paths and test circuits
APPENDIX F - Test apparatus for explosive mixtures or
atmospheres
APPENDIX G - Impact-test apparatus
APPENDIX H - Screwed terminal connections
APPENDIX J - Mains supply transformers
APPENDIX K - MEDICAL ISOLATING TRANSFORMERS
APPENDIX L - List of IEC Standards (according to the
Catalogue of Publications, 1977) and ISO
Standards (Catalogue 1977) mentioned in
this publication
ALPHABETICAL INDEX