ISO 14708-3 PDF

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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The higher test levels represent environments to which the general public might occasionally be exposed, are generally more avoidable, and when exposure does occur, it’s generally for a shorter duration. If the manufacturer does not uso this determination then the excess average count shall not exceed per ml greater than 5,0 jm and shall not exceed 5 per ml greater than 25 jm. Step sizes as specified isoo reasonable coverage of the frequency range without creating a burdensome number of test measurements.

The related specifications ixo characteristics stated by the manufacturer in the accompanying documentation see The new requirement, referring to lEGwill insure that devices are tested to levels that are currently considered appropriate. NOTE A risk assessment can demonstrate that a hazard, created as a result of performance degradation, loss of function, 114708-3 an unintentional response, does not result in an unacceptable risk.

Side a will be oriented in the direction of the electric field. Place the DUT at the centre of the central plane where the magnetic field is the most uniform. Since every conceivable situation cannot be foreseen, an allowance is made for temporary degradation of performance and unintentional responses as long as patient safety is maintained. More complex impedances may be used if they better represent actual use.

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Search the history of over billion web pages on the Internet. The remainder of the lead side b is kept orthogonal to the electric field in order to minimize io opposite polarity voltage developing across that side.

The burden of proof is upon the manufacturer to demonstrate via a 41708-3 analysis, design analysis, test studies or other appropriate means. Measurements shall be replicated to characterize operation at minimum, typical and maximum load impedances.

This allowance has to become the judgment of the manufacturer and regulatory personnel. It will be necessary to estimate the total area enclosed by the test lead. The total area enclosed by a lead of length L in centimetres shall equal: It uso reasonable to require an immunity test level above that required for non-implantable medical iwo, at the same time keeping it in line with real-world sources commonly encountered by the general public.

General requirements [7] ISO Evaluation of test results: Modulation requirements are specified in test procedures [8] below.

ANSI/AAMI/ISO (PDF)

Test documentation shall describe the DUT configuration and environmental conditions affecting the test e. The connector block area of a typical neurostimulator, with titanium enclosure, is the most susceptible to short wavelength electric fields. According to the rationale in lECamplitude modulation has advantages over other methods.

In this environment the device is expected to be free from damage and unacceptable risk. An external programmer might be used to adjust device parameters. Historically, many implantable devices had magnetically activated reed switches internal to the sealed enclosure that were used for control purposes.

Anthropometric data for a 95th percentile man see references [25] and [26] indicates that the longest dimensioned lead in a torso would be placed 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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All other functions shall comply with the requirements as stated.

Association for the Advancement of Medical Instrumentation

A consideration for performing the test in saline is the size of the saline tank. If the results of a risk assessment or other means e. Evaluation and testing [5] ISO NOTE The card can be shown to security oso medical personnel izo will be aware of procedures to avoid electromagnetic interference and high power electromagnetic fields, if they have been informed the patient has an implanted medical device.

Environment — Section 5: Test levels vary depending on frequency and 1470-3 criteria [see The test requires this area of the enclosure to be presented parallel to the electric field polarization in order to maximize coupling. Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments.

In this way, use of the neurostimulator can be allowed so its clinical 14708- can be enjoyed by the patient. The notes in this annex carry the numbers of the relevant clauses of this part of ISOtherefore, paragraph numbering in this annex is not consecutive. Attention is particularly drawn to the following:

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