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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Resistor values for shall be determined by the manufacturer based on appropriate tissue impedances for use of the product. The requirement does not apply to energy sources that cannot be depleted, such as line-powered devices.

The plane of the largest surface area of the 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. For electric fields, susceptibility is usually dependant upon neurostimulator design implementation. If the longest dimension of the IPG connector block is also aligned with side a of the lead then a single orientation of the DUT is sufficient for test.

The exclusion band shall not be larger than normally required for the telemetry function 1470-3 operate as intended. General requirements for safety, marking and for Information to be provided by the manufacturer I EC It should be possible to read this code, if necessary, without the need for a surgical operation.

More complex impedances may be used if they better represent actual use. If the lead or extension has multiple conductors, the d. It will be necessary to estimate the total area enclosed by the test lead. Processing, reservation, testing and handling of tissues, cells and substances of animal origin should be carried out so as to provide optimal security. Environment — Section 1470-83 Standards are also reviewed periodically; a standard along with amendments is reaffirmed when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision.

The limits presented in these isl can be used as a guideline for setting immunity test levels based on the presumption that public exposure to electromagnetic fields should be limited. The actual rate is calculated from the reciprocal of the interval measurement. NOTE The card can be isk to security 1408-3 medical personnel who will be aware 144708-3 procedures to avoid electromagnetic interference and high isso electromagnetic fields, if they have been informed the patient has an implanted medical device.

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The dwell time at each step shall be long enough for the DUT to adequately respond to 14078-3 test signal, but not less than 15 s. These are levels typical isso a home environment, including power lines, transportation, common areas school, retail, office and hospitaland office equipment; and where exposure is more likely to occur with longer duration. Side a will be oriented in the direction of the electric field. Depending on proximity and source, field strengths might be higher.

If the neurostimulator has multiple channels or output modes e. NOTE 2 Not applicable to active implantable medical devices. If DUT performance satisfies the criteria stated, then compliance with the requirements of the test s is, consequentially, achieved.

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.

The result shall be expressed in Hertz Hz. 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.

This information comprises the details on the label and the data in the instructions for use. NOTE A risk assessment can demonstrate that a hazard, created as a result of performance degradation, loss of function, or an unintentional response, does not iwo in an unacceptable risk. Any part of the implantable neurostimulator, intended in normal use to be in contact with body fluids, shall be evaluated to determine if the release of particulate matter is hazardous.

Association for the Advancement of Medical Instrumentation

For most test setups a uniform area of radius 7,5 cm will be large enough to cover the DUT. The data in the figure already account for localization effects based on homogeneity of source field including size and proximity according to lEC ]. The current edition of this part of ISO does not define “function” in Clause 3 however, because it is conceivable that a function that is not clinically significant could somehow be associated with essential performance and, would therefore, be subject to the immunity tests.

Requirements related to signal injection and parameter programming, as used in PC69, are not applicable. The following degradations are not allowed: This formula is valid for a semi-circle and will have to be applied accordingly. The maximum induced voltage comes from a lead loop perpendicular to a magnetic field. The lower test levels are based on common, everyday exposure conditions.

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The test requires this area of the enclosure to be presented parallel to the electric field polarization in order to maximize coupling. NOTE 2 Configuration refers to the point of measurement and to the model isoo of pulse generator, and leads and extensions, if applicable. General requirements for basic safety and essential performance — Collateral standard: The modulation rate is Hz which is close to the physiological passband and avoids power line frequencies and typical stimulation rates.

However, it does apply to devices intended to be used as trial screeners because of their close affiliation with implantable neurostimulators. Not all of 114708-3 components or accessories might be required to be partially or totally implanted, e.

ANSI/AAMI/ISO (PDF)

An implantable neurostimulator shall be designed so that the failure of any single component, part or if the device incorporates a programmable electronic system software program shall not cause an unacceptable hazard. The excess average count of particles from the specimen compared to the reference sample shall not exceed the amount determined, by the manufacturer, to be hazardous.

Place the DUT at the centre of the central plane where the magnetic field is the most uniform. If no standards exist, the symbols and colours should be described in the documentation supplied with the implant.

IPG, RF receiver, trial screener shall be connected to a load resistor, and test equipment as shown in Isso In addition, a uniform load impedance is specified for comparative purposes. Amplitude modulation is used to be consistent with the requirements of lEC for non-implantable parts. These shall be referred to as the A-line and the B- line, respectively, throughout this subclause.

The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard. The load isoo used to obtain the stimulation pulse characteristics stated in the accompanying documentation see

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