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Standards Referenced in AAMI 60601-2-4

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AAMI DF2 1996 Edition, 1996
Cardiac Defibrillator Devices

AAMI DF2

1996 Edition, 1996

Complete Document
 
Cardiac Defibrillator Devices
Additional Comments:
W/D S/S BY AAMI DF80
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AAMI DF39 1993 Edition, 1993
Automatic External Defibrillators and Remote-Control Defibrillatiors

AAMI DF39

1993 Edition, 1993

Complete Document
 
Automatic External Defibrillators and Remote-Control Defibrillatiors
Additional Comments:
W/D S/S BY AAMI DF80
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AAMI EC12 2000
Disposable ECG electrodes
Includes all amendments and changes through Reaffirmation Notice , 2015

AAMI EC12

2000

Complete Document
 
Disposable ECG electrodes
Includes all amendments and changes through Reaffirmation Notice , 2015
Additional Comments:
FDA RECOGNIZED
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AAMI EC13 2nd Edition, 2002
Cardiac monitors, heart rate meters, and alarms
Includes all amendments and changes through Reaffirmation Notice , 2007

AAMI EC13

2nd Edition, 2002

Complete Document
 
Cardiac monitors, heart rate meters, and alarms
Includes all amendments and changes through Reaffirmation Notice , 2007
Additional Comments:
W/D S/S BY AAMI 60601-2-27
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IEC 60300-3-9 1st Edition, December 1995
Dependability Management - Part 3: Application Guide - Section 9: Risk Analysis of Technological Systems
(Document Language: English and French)

IEC 60300-3-9

1st Edition, December 1995

Complete Document
 
Dependability Management - Part 3: Application Guide - Section 9: Risk Analysis of Technological Systems
Superseded By:
EN
FR
Additional Comments:
BILINGUAL * W/D S/S BY IEC/ISO 31010
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IEC 60601-1 3.1 Edition, August 2012
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
Includes all amendments and changes through Corrigendum 1, August 2012

IEC 60601-1

3.1 Edition, August 2012

Complete Document
 
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
Includes all amendments and changes through Corrigendum 1, August 2012
Active, Most Current
EN
Additional Comments:
INCORPORATES ALL PREVIOUS UPDATES
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IEC 60601-1-2 4th Edition, February 2014
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
(Document Language: English and French)

IEC 60601-1-2

4th Edition, February 2014

Complete Document
 
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Active, Most Current
EN
FR
Additional Comments:
BILINGUAL
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PDF   : $375.00
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IEC 60601-2-27 3rd Edition, March 2011
MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
Includes all amendments and changes through Corrigendum 1, May 2012

IEC 60601-2-27

3rd Edition, March 2011

Complete Document
 
MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
Includes all amendments and changes through Corrigendum 1, May 2012
Active, Most Current
Additional Comments:
BILINGUAL
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PDF   : $352.00
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IEC 61000-4-2 2nd Edition, December 2008
Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
(Document Language: English and French)

IEC 61000-4-2

2nd Edition, December 2008

Complete Document
 
Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
Active, Most Current
EN
FR
Additional Comments:
BILINGUAL
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ISO 15223-1 3rd Edition, November 1, 2016
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

ISO 15223-1

3rd Edition, November 1, 2016

Complete Document
 
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
Active, Most Current
EN
Additional Comments:
ENGLISH * CORRECTED AND REPRINTED 03/00/2017
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PDF   : $138.00
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