Partie 3: Neurostimulateurs en implant. STANDARD. ISO. Second edition. Reference number. ISO (E). Provläsningsexemplar /. Summary: Specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral. ISO Implants for surgery —. Active implantable medical devices — Part 3: Implantable neurostimulators. American. National. Standard.
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Association for the Advancement of Medical Instrumentation
Some examples of unintentional responses are a 144708-3 in pulse width or amplitude outside of normal operating 14078-3, or a pulse or spike where none was intended. The solid line in Figure represents test levels that are subjected 147088-3 the DUT, applying performance criterion A, as stated in A sample of liquid from the specimen bath and from the reference bath shall be compared using apparatus suitable for measurement of particle size, such as apparatus operating on the light blockage principle [see method 2.
Figure — IPG and lead layout on central plane Any ancillary equipment that is needed to operate the neurostimulator or monitor its output during the test shall, as much as possible, be selected and located to minimize disruption of the uniform field.
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One orientation of the DUT in the test fixture, with its largest 17408-3 exposed to the primary magnetic field vector, is sufficient to test for interactions. Extraordinary device behaviour is not expected to occur typically, and the 10x test levels should verify this experimentally. The exclusion band shall not be larger than normally required for the telemetry function to operate as intended. Copyright BIS has the copyright of all its publications. A saline bath is used to simulate the in vivo environment of the neurostimulator in normal use.
The actual rate is calculated from the reciprocal of the interval measurement. The uniformity is relaxed at higher frequencies and test levels due to test fixture limitations. Using the frequency sweep method or smaller step sizes will result in more frequencies being tested.
When perfusion is considered, larger local temperatures increases can be considered. Remove the implantable part aseptically from the non-re-usable pack. In particular, if pulse shapes or other characteristics are different depending on output mode, state or configuration these elements of device operation need to be brought to the attention of the user. The implantable parts of the neurostimulator shall be constructed to withstand the mechanical forces that can occur during normal conditions of use.
NOTE 2 Not applicable to active implantable medical devices. No part of these publications may be reproduced in any form without the prior permission in writing of BIS. Step sizes as specified give reasonable coverage of the frequency range without creating a burdensome number of test measurements.
Resistor values for shall be determined by the manufacturer based on appropriate tissue impedances for use of the product. In this way, use of the neurostimulator 147083 be allowed so its clinical benefit can be enjoyed by the patient.
Electrically powered non-implantable parts are covered by the requirements of Clause 5. Other treatments and procedures, such as but not limited to MRI, PET scans, therapeutic ultrasound and lithotripsy, shall also be considered.
Test levels vary depending on frequency and performance criteria [see This requirement applies to any part with an energy source that can become depleted, not just to implanted parts. The result shall be expressed in microseconds. The test setup for the implantable part shall be based on the setup described in Figure 1 of lEC Electromagnetic compatibility — Requirements and tests lEC Any variations in pulse shapes, between channels, output modes, states of operation or load conditions, shall also be described.
Sources in this category include the higher powered electronic article surveillance EAS gates and higher powered mobile communications equipment. Non-implantable neurostimulators that are used for other purposes and that cannot be considered as accessories to an implantable neurostimulator, are excluded from the scope of this part of ISO Compliance shall be checked as specified In lEC NOTE For leads that are not intended to be implanted and are used only temporarily, this requirement does not apply.
This standard is intended to apply to these neurostimulators types regardless of therapy.
Lead length and layout are described in the test setup for each test. NOTE For example, essential performance could very well be related to pulse amplitude or to other output characteristics where a sudden change could be hazardous.
Placing the IPG in the orientation shown in Figure will facilitate testing, as only one orientation of the test setup will need to be exposed to the electric field.
The design should allow easy handling and, where necessary, minimize contamination of the implant by the patient or vice versa during use.
Compliance shall be checked as specified in lEC The RF receiver needs only to be subjected to radiated immunity in accordance with lEC The standard level of 40 mW is to simulate a hand held wireless transmitter 15 cm from an implant, which is a generally accepted reasonable distance.
All field levels are root-mean square RMS. The pulse generator i. Environment — Section 5: Usually, a function can be thought of as a clinically significant feature that the device is intended to provide. The uniform field shall exist over an area of radius 7,5 cm minimum that lies on a plane parallel to the coil s. These shall be referred to as the A-line and the B- line, respectively, throughout this subclause.