ISO 14708-1 PDF

Active, Most Current. Look Inside. ISO 2nd Edition, August 15, Complete Document. Detail Summary View all details.

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This part of ISO 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 The tests that are specified in ISO are type tests and are to be carried out on samples of an active implantable medical device to show compliance. This part of ISO 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 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.

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. Update Cart. Your Shopping Cart is empty.

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ISO 14708-1:2014

ISO specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO are type tests and are to be carried out on samples of an active implantable medical device to show compliance. ISO 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. ISO is also applicable to some non-implantable parts and accessories of the active implantable medical devices. Check out our FAQs.

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ISO 14708-1

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