AAMI EC38 : 2007

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of IEC 60601-2-47:2001
AAMI Deviations to IEC 60601-2-47:2001
SECTION ONE - GENERAL
1 Scope and object
   1.1 Scope
   1.2 Object
   1.3 Particular Standards
   1.5 Collateral Standards
2 Terminology and definitions
5 Classification
6 Indentation, marking and documentation
          6.8.2 Instructions for use
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
          10.2.1 Environment
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength
   20.3 Values of test voltages
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 ELECTROMAGNETIC COMPATIBILITY
   36.201 Emissions
          36.201.1 Radio frequency (RF) emissions
   36.202 Immunity
          36.202.1 Electrostatic discharge
          36.202.2 Radiated radio-frequency electromagnetic fields
          36.202.6 Magnetic fields
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 analysis
          50.101.1 Standard databases to be used to evaluate
                   automated analyses
          50.101.2 Performance reporting requirements
          50.101.3 Physician report - minimum requirements
51 Protection against hazardous output
   51.5 Incorrect output
          51.5.1 Input dynamic range
          51.5.2 Input impedance
          51.5.3 Common mode rejection
          51.5.4 Gain accuracy
          51.5.5 Gain stability
          51.5.6 Amplitude calibration
          51.5.7 System noise
          51.5.8 Multichannel crosstalk
          51.5.9 Frequency response
          51.5.10 Minimum feature size
          51.5.11 Function in the presence of pacemaker pulse
          51.5.12 Timing accuracy
          51.5.13 Hard copy grid standard
          51.5.14 Gain settings and switching
          51.5.15 Temporal alignment
          51.5.16 Special considerations for high speed
                   superimposition display (optional)
          51.5.17 Lead Definitions
          51.5.18 Baseline stability
          51.5.19 Patient event marks
          51.5.20 Full disclosure (miniature displays)
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
   56.7 Batteries
          56.7.101 Monitoring time and retention of data
Annexes
Appendix L-References - Publications mentioned in this Standard
Annex AA (informative)-Guidance and rationale

Describes the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS as defined in 2.101.