ISO 14708-2:2019
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers

Standard No.

ISO 14708-2:2019

Release Date

2019

Published By

International Organization for Standardization (ISO)

Latest

ISO 14708-2:2019

Scope

This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies. Any features of an active implantable medical device intended to treat tachyarrhythmias are covered NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.

ISO 14708-2:2019 Referenced Document

• ISO 11318:2002 Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensional and test requirements
• ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
• ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
• ISO 27186:2010 Space systems - Programme management - Quality assurance requirements
• ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers

ISO 14708-2:2019 history

• 2019 ISO 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
• 2012 ISO 14708-2:2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
• 2005 ISO 14708-2:2005 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers