• Shopping Cart
    There are no items in your cart

AAMI ISO 14117 : 2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

31-10-2019

Superseded by

ANSI/AAMI/ISO 14117:2019

Language(s)

English

Published date

01-01-2012

€253.04
Excluding VAT

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 14117:2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviations
4 Test requirements for the frequency band 0 Hz
  <= f <= 3,000 MHz
5 Testing above frequency of 3,000 MHz
6 Protection of devices from EM fields encountered in a
  therapeutic environment
7 Additional accompanying documentation
Annex A (informative) - Rationale
Annex B (informative) - Rationale for test frequency ranges
Annex C (informative) - Code for describing modes of
        implantable generators
Annex D (normative) - Interface circuits
Annex E (informative) - Selection of capacitor C[x]
Annex F (normative) - Calibration of the injection network
Annex G (normative) - Torso simulator
Annex H (normative) - Dipole antennas
Annex I (normative) - Pacemaker/ICD programming settings
Annex J (normative) - Simulated cardiac signal
Annex K (normative) - Calculation of net power into
        dipole antenna
Annex L (informative) - Loop area calculations
Annex M (informative) - Correlation between levels of
        test voltages used in this International Standard
        and strengths of radiated fields
Bibliography

Describes test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization.

Committee
PC
DevelopmentNote
Supersedes AAMI PC69. (01/2013)
DocumentType
Standard
Pages
128
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 14117:2012 Identical

SAE J 2954 : 2017 WIRELESS POWER TRANSFER FOR LIGHT-DUTY PLUG-IN/ELECTRIC VEHICLES AND ALIGNMENT METHODOLOGY

EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
ISO/IEC Guide 51:2014 Safety aspects — Guidelines for their inclusion in standards
ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
ANSI C63.5 : 2006 ELECTROMAGNETIC COMPATIBILITY - RADIATED EMISSION MEASUREMENTS IN ELECTROMAGNETIC INTERFERENCE (EMI) CONTROL - CALIBRATION AND QUALIFICATION OF ANTENNAS (9 KHZ TO 40 GHZ)
IEEE C95.6-2002 IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz
DIN VDE 0848-3-1 : DRAFT 2002 SAFETY IN ELECTRICAL, MAGNETIC AND ELECTROMAGNETIC FIELDS - PART 3-1: PROTECTION OF PERSONS WITH ACTIVE IMPLANTS IN THE FREQUENCY RANGE 0 HZ TO 300 GHZ
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 14708-6:2010 Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.