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