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ISO 14708-1 2nd Edition, August 15, 2014 Implants for Surgery - Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and for Information to be Provided by the Manufacturer
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Availability date: 07/13/2021
Description / Abstract:
This part of ISO 14708 specifies requirements that are generally
applicable to active implantable medical devices.
NOTE 1 For particular types of active implantable medical
devices, these general requirements are supplemented or modified by
the requirements of particular parts of ISO 14708.
The tests that are specified in ISO 14708 are type tests and are
to be carried out on samples of an active implantable medical
device to show compliance.
This part of ISO 14708 is applicable not only to active
implantable medical devices that are electrically powered but also
to those powered by other energy sources (for example by gas
pressure or by springs).
This part of ISO 14708 is also applicable to some
non-implantable parts and accessories of the active implantable
medical devices.
NOTE 2 The device that is commonly referred to as an active
implantable medical device can 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 3 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.
NOTE 4 The terminology used in this part of ISO 14708 is
intended to be consistent with the terminology of ISO/TR
14283:2004.