ANSI/AAMI/ISO 14708-3-2017 pdf download.Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators.
This document is applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Iso 14117:2012, Active implantable medical devices一Electromagnetic compatibility- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 14708-1:2014, Implants for surgery一Active implantable medical devices 一Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Iso 14971, Medical devices一Application of risk management to medical devices
ISO/TS 10974:- -1 ， Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
IEC 60601-1 :2005+A1:2012, Medical electrical equipment 一Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, Medical electrical equipment一Part 1-2: General requirements for basic safety and essential performance一Collateral standard: Electromagnetic disturbances一Requirements and tests
IEC 61000-4-3:2006+A1 :2007+A2:2010, Electromagnetic compatibility (EMC)一Part 4-3: Testing and measurement techniques一Radiated, radio-frequency, electromagnetic field immunity test
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISo 14708-1 and the fllowing apply.
ISO and IEC maintain terminological databases for use in standardization at the ollowing addresses:
一IEC Electropedia: available at htp://www.electropedia.org/
ISO Online browsing plattorm: available at htp://ww.iso.org/oboop
3.101 implantable neurostimulator
INS active implantable medical device intended for elecrical stimulation of the central or peripheral nervous system
Note 1 to entry: For the purposes of this document, an implantable neurostimulator can be a single article, or a system consisting of a set of components and accessories which interact to achieve the performance intended by the manufacturer. Not all of these components or accessories might be required to be partially or totally implanted, e.g. programmers.
3.102 implantable pulse generator IPG
part of an implantable neurostimulator (3. 101), consisting of a power source and electronic circuit, which produces a
stimulation voltage or current pulse
3.103 MR Conditional
item with demonstrated safety in the MR environment within defined conditions
Note 1 to entry: Adapted from ASTM F2503, 3.1.11.
3.104 projected service lite
period after implantation when the implantable neurostimulator (3.101) remains within stated specifications and characteristics
3.105 DUT device under test
device being tested, including conductive leads
Note 1 to entry: Not all tests require conductive leads.
4 Symbols and abbreviated terms
This clause of ISO 14708-1 applies.ANSI/AAMI/ISO 14708-3 pdf download.