FOREWORD
INTRODUCTION
Clause
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
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
34 Ultraviolet radiation
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to PRESSURE
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
Figures
APPENDIX D - Symbols
Annexes
AA - General guidance and rationale
BB - Graphical representation of the permissable
operating areas of the EQUIPMENT in NORMAL and
SINGLE FAULT CONDITIONS
FOREWORD
INTRODUCTION
Clause
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
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
34 Ultraviolet radiation
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to PRESSURE
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
Figures
APPENDIX D - Symbols
Annexes
AA - General guidance and rationale
BB - Graphical representation of the permissable
operating areas of the EQUIPMENT in NORMAL and
SINGLE FAULT CONDITIONS