I.S. HD 395.1:1995

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

This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. It also contains certain requirements for reliable operation to ensure safety.