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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If DUT performance satisfies the criteria stated, then compliance with the requirements of the test s is, consequentially, achieved. This formula is valid for a semi-circle and will have to be applied accordingly. The result shall be expressed in volts or milliamperes, as appropriate. 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 data in the figure already account for localization effects based on homogeneity of source field including size and proximity according to lEC ].
General requirements  ISO The sinusoidal carrier shall have an on-time of 1,6 ms and an off-time of 3,4 ms every modulation cycle. The related specifications and characteristics stated by the manufacturer in the accompanying documentation see The result shall be expressed in Hertz Hz.
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. Particular attention should be paid to the tissues exposed and to the duration and frequency of exposure.
Place the DUT at the centre of the central plane where the magnetic field is the most uniform. In theory, the pulsation factor for the electric field could be as high as 32 in persons without implants. Environment — Section 7: The lower test levels are based on common, everyday exposure conditions.
Not isi parts or accessories might be intended to be totally or partially implanted, but there is need to specify some requirements of non-implantable parts and accessories, if they could affect the safety or performance intended by the manufacturer.
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.
It seems reasonable to require an immunity test level above that required for non-implantable medical devices, at the same time keeping it in line with real-world sources commonly encountered by the general public. 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.
It only needs to be placed in a position that facilitates monitoring of the neurostimulator during the test.
Using the frequency step method and meeting the minimum step size requirements will result in the frequencies being tested that are listed in Table Both field strengths stated are the levels of the unmodulated test signal. This allowance has to become the judgment of the manufacturer and regulatory personnel. The A-line is intended to represent common, everyday exposure of the general public, to magnetic fields. In addition, other units can be used if the manufacturer chooses. They produce controlled electrical pulses that are delivered through electrodes in contact with a specific target area.
Unless the manufacturer knows from prior testing, it might be necessary to test all electrode configurations to discover worst case susceptibility.
Association for the Advancement of Medical Instrumentation
Compliance shall be confirmed by a review of the risk management report or equivalent manufacturer’s documents. Clause 23 of lEC It will be necessary to estimate the total area enclosed by the test lead. This information comprises the details on the label and the data in the instructions for use. If not, the uniform area shall be increased until it meets the requirements of this subclause. The modulation rate is Hz which is close to the physiological passband and avoids power line frequencies and typical stimulation rates.
NOTE For magnetic field tests the electrode configuration that is normally the most susceptible is unipolar.
If the lead or extension has multiple conductors, the d. It should be possible to read this code, if necessary, without the need for a surgical operation.