IEC 60601-2-51:2003

FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
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
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
   50.101 Automated measurements on ECGs (for ANALYSING
          ELECTROCARDIOGRAPHS)
   50.102 Automated ECG interpretation (for ANALYSING
          ELECTROCARDIOGRAPHS)
51 Protection against hazardous output
   51.101 LEADS
   51.102 Input circuit
   51.103 CALIBRATION
   51.104 SENSITIVITY
   51.105 Reduction of the effects of unwanted external voltages
   51.106 Base-line
   51.107 Distortion
   51.108 Printing, electronic storage and transmission
   51.109 Use with cardiac pacemakers
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
   56.7 BATTERIES
Appendix L (normative) References - Publications mentioned in
                       this standard
Annex AA (informative) General guidance and rationale
Annex BB (informative) ELECTRODES, their positions,
                       identifications and colour codes
Annex CC (informative) LEADS and their identification (other
                       described in 51.101)
Annex DD (informative) Polarity of PATIENT LEADS (other than
                       those specified in 51.101)
Annex EE (informative) Additional marking of electrodes
Annex FF (informative) Noise
Annex GG (normative) Definitions and rules for the measurement
                     of ELECTROCARDIOGRAMS
Annex HH (normative) Calibration and test data sets
Annex II (informative) CTS test atlas
Bibliography
INDEX OF DEFINED TERMS

Establishes particular requirements, in addition to the requirements of IEC 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs.These requirements shall apply particularly to- recording electrocardiographs;- electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes;- electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit;- analyzing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG;- those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analyzing electrocardiographs.