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AAMI DF80 : 2003 : R2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS]
Available format(s)

Hardcopy , PDF

Superseded date

10-14-2010

Language(s)

English

Published date

01-01-2010

Glossary of equivalent standards
Committee representation
Background
FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking, and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 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
SECTION FIVE - PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility (EMC)
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,
    disinfection, and compatibility
46 Human errors
SECTION EIGHT - ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 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
SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY
101 Charging time
102 Internal electrical power source
103 Endurance
104 Synchronizer
105 Recovery of the MONITOR/ECG INPUT after defibrillation
106 Disturbance to the monitor from charging or internal
    discharging
107 Defibrillator electrodes (U.S.)
108 External pacing (U.S.)
Annexes
Appendix L References - Publications mentioned in this Standard
Annex AA (informative) - General guidance and rationale
Annex BB (informative) - AUTOMATED EXTERNAL DEFIBRILLATORS:
                         background and rationale
Annex CC (informative) - General guidance and rationale
                         for additional U.S. requirements (U.S.)
Annex DD (informative) - Historical background on
                         defibrillation waveforms (U.S.)
Annex EE (informative) - Cited references in Annexes CC
                         and DD (U.S.)

Describes the requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101, hereinafter referred to as EQUIPMENT.

Committee
DF
DevelopmentNote
Supersedes AAMI TIR2. Supersedes AAMI DF2 and AAMI DF39 (11/2003)
DocumentType
Standard
Pages
81
ProductNote
Reconfirmed 2010
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
Supersedes

Standards Relationship
IEC 60601-2-4:2010 Identical

IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
AAMI DF39 : 1ED 93 AUTOMATIC EXTERNAL DEFIBRILLATORS AND REMOTE-CONTROL DEFIBRILLATORS
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters

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