M00001232
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ISO 14708-2 2nd Edition, August 15, 2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
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Availability date: 07/13/2021
Description / Abstract:
This part of ISO 14708 specifies requirements that are
applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to
treat bradyarrhythmias.
The tests that are specified in this part of ISO 14708 are type
tests, and are to be carried out on samples of a device to show
compliance.
This part of ISO 14708 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 by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an ACTIVE
IMPLANTABLE MEDICAL DEVICE may 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 nonimplantable parts and accessories
if they could affect the safety or performance of the implantable
device.
NOTE 2 In this part of ISO 14708, terms printed in SMALL CAPITAL
LETTERS are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in small
capital letters unless the concept thus qualified is also
defined.