ANSI/AAMI/ISO 14117:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Hardcopy , PDF
English
07-10-2019
03-01-2026
AAMI EMC Test Protocols for Pacemakers, ICDs & CRTs Working GroupCRMD, EMC, pacemakers, cardiacThis document specifies 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 in conjunction with transvenous lead systems.
| Committee |
ISO/TC 150
|
| DocumentType |
Test Method
|
| ISBN |
978-1-57020-728-0
|
| Pages |
152
|
| ProductNote |
This standard also refers to DIN VDE 0848-3-1:2003-10,EN 50061,ANSI/AAMI PC69:2000,IEEE C95.6:2003,1999/519/EC,2013/35/EU,EN 301489-1, EN 301489-27,EN 301489-29,EN 301489-31, EN 301489-35,ERC Recommendation 70-03.
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14117:2019 | Identical |
| AAMI PC69 : 2007 | Active implantable medical devices— Electromagnetic compatibility— EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators American National Standard |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 5841-3:2013 | Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
| ISO 27186:2010 | Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| EN 50527-1:2016 | Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General |
| ISO 11318:2002 | Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
| EN 50527-2-1:2016 | Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers |
| EN 45502-2-2:2008 | Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
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