ISO 14708-3 PDF


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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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Using a factor of 0,62 for side a in Figure keeps the side exposed to the parallel electric field proportional to the overall lead length. Environment — Section 3: The limits presented in these standards can be used as is guideline for setting immunity test levels based on the presumption that public exposure to electromagnetic fields should be limited.

ANSI/AAMI/ISO (PDF)

This standard is intended to apply to these neurostimulators types regardless of therapy. This part of ISO incorporates the requirements and test methods of PC69 due to the equivalencies between implantable pacemakers and implantable neurostimulators regarding the patient environment, appropriate mechanical and electrical design elements, and the application of the products in vivo.

Modulation requirements are specified in test procedures [8] below. The design should allow easy handling and, where necessary, minimize contamination of the implant by the patient or vice versa during use.

Association for the Advancement of Medical Instrumentation

For dated references, only the edition cited applies. Therefore, it is expected that all devices will function normally when in the presence of a 1 mT field. The exclusion band shall not be larger than normally required for the telemetry function to operate as intended. Side a will be oriented in the direction of jso electric field. Resistor values for shall be determined by the manufacturer based on appropriate tissue impedances for use of the ios.

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Any variations in pulse shapes, between channels, output modes, states of operation or load conditions, shall also be described. For most test setups a uniform area of radius 7,5 cm will 114708-3 large enough to cover the DUT. Therefore, performance ios, post-test, are set accordingly. The pulse generator i. The test requires this area of the enclosure to be presented parallel to the electric field polarization 14780-3 order to maximize coupling.

Emitters in this frequency range, which include amateur radio, AM radio, time and frequency broadcasts, ISM, personal and private radio services, and maritime radio-navigation, have not been known to cause interference with implantable neurostimulators. The test setup for the implantable part shall be based on the setup described in The requirements of Clause 6 of PC Other treatments and sio, such as but not limited to MRI, PET scans, therapeutic ultrasound and lithotripsy, shall also be considered.

Specific requirements might be specified in future editions of this part of ISO It is very important that the patient and physician understand the risks involved with implantable devices.

By “risks during normal conditions and fault isso are meant those risks which have been determined by a risk analysis. Anthropometric data for a 95th percentile man see references [25] and [26] indicates that the longest dimensioned lead in a torso would be izo abdominally and routed up the spine to C1 forming two sides of a right triangle with abdominal length of 32 cm and spinal length of 53 cm, for a total lead length of 85 cm.

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The note explains that removable stickers are excluded if they contain information beyond the requirements in this part of ISO The starting frequency of each decade is, respectively: Since this testing is optional, the manufacturer is allowed the discretion to set the performance criteria on which to base these claims.

Frequency steps were chosen to cover a representative sample of sources occupying the frequency range. Particular attention should be paid to implants whose intended use includes exposure to flammable substances or to substances which could cause combustion.

The limits of accuracy should be indicated by the manufacturer. Based on performance results from the tests in Clause 27, it might be necessary to include warning notices in the user documentation.

Step sizes as specified give reasonable coverage of the frequency range without creating a burdensome number of test measurements. Long leads might need to be folded back, always keeping the excess 1470-3 parallel to side b.

The plane of the largest surface area of ieo DUT is placed parallel to the central plane this exposes the neurostimulator’s largest surface to the primary magnetic flux lines which are perpendicular to the central plane.