EN 60601-1-1:2001

FOREWORD
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
               EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
              ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
                OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids,
   cleaning, sterilization, disinfection and compatibility
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
                HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Annex AAA (informative) General guidance and rationale
Annex BBB (informative) Examples of combinations of MEDICAL
          ELECTRICAL EQUIPMENT and non-medical electrical equipment
Annex CCC (normative) Normative references
Annex DDD (informative) Bibliography
Annex EEE (normative) Requirements for MULTIPLE PORTABLE
          SOCKET-OUTLETS
Annex FFF (informative) Examples of application of MULTIPLE PORTABLE
          SOCKET-OUTLETS
Annex ZA (normative) Normative references to international
         publications with their corresponding European publications
Annex ZB (informative) Bibliography

Applies to the safety of medical electrical systems, as defined as follows: combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet. Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings. Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.