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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In this way, use of the neurostimulator can be allowed so its clinical benefit can be enjoyed by the patient. Test equipment and test sample shall be at room temperature. NOTE 3 Not applicable because 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. The test requires this area of the enclosure to be presented parallel to the electric field polarization in order to maximize coupling.
Static magnetic field strengths, right on the surface of common household magnets e. This does not preclude the free use, in course of imple- menting the standard, of necessary details, such as symbols and sizes, type or grade designations. The lower test levels are based on common, everyday exposure conditions.
The exposure duration shall be long enough for the DUT to adequately respond to the test signal, but not less than 15 s. 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.
All other functions shall comply with the requirements as stated. The data in the figure already account for localization effects based on homogeneity of source field including size and proximity according to lEC ]. The upper level is pulse modulated rather than AM primarily due to test facility limitations producing large amplitude fields. If not, the uniform area shall be increased until it meets the requirements of this subclause.
The test is performed on one orientation of the DUT as described in Test setup. Note 2 The instructions for use should also include details allowing the medical staff to brief the patient iwo any contra- indications and any precautions to be taken.
Using the frequency sweep method or smaller step sizes will result in more frequencies being tested. They found a factor lso approximately 1 ,5 to be reasonable to relate the electrical and geometric areas, but this part of ISO is based on a more conservative factor of 1,3.
Remove the implantable part aseptically from the non-re-usable pack. 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.
Above 27 MHz the electric field attenuation of the titanium enclosure is greater than 35 dB, except for the connector block area. Recently, certain countries have taken steps to pass legislation controlling source emissions to iwo the general public.
The lead length was chosen from anthropometric data for a 95th percentile man see references  and [ 26] which 1470-83 that the longest dimensioned lead in a torso would be placed 14078-3 and routed up the spine to CI forming two sides of a right angled triangle with abdominal length of 32 cm and spinal length of 53 cm.
Some degradations are not allowed because of safety concerns and because they are not justified by the severity of isi test levels. This illustration is based on the frequency step method using minimum required step sizes.
Association for the Advancement of Medical Instrumentation
Therefore, general public exposure to magnetic fields represented by the B-line is considered to be possible, relatively infrequent and for short duration when occurring, and generally avoidable when sources are known.
Device settings refer, for example, to the rate and pulse width values that were set during the amplitude measurement. For example, if a lead is 85 cm in length, the length of side a would be 53 cm. This is the only orientation of the DUT that is required. For most test configurations [see Only the magnetic fields are considered to have a potential for causing disturbances in implantable neurostimulators.
These are levels typical of 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. Two test field strengths are used, applying different performance criteria to each.
Therefore, performance criteria, post-test, are set accordingly. Performance criteria, during test, are set according to test level.
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 result in an unacceptable risk. Table — Frequencies tested using minimum step size requirements kHz 0,01 0,02 0,03 0,04 0,05 0,06 0,07 0,08 0,09 0,1 147083- 0,3 0,4 0,5 0,6 0,7 0,8 0,9 1 2 3 4 5 6 7 8 9 10 20 30 40 50 60 70 80 90 1 2 3 4 5 6 iwo 8 9 10 io 30 NOTE Frequencies are in kHz.
The number of significant places retained in the rounded off value should ieo the same as that of the specified value in this standard. The test sample shall be representative of production units, be in normal working condition, and shall not have reached the elective replacement indication see 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.
The implantable parts of the neurostimulator shall be constructed to withstand the mechanical forces that can occur during normal conditions of use. All field levels are root-mean square RMS. The sinusoidal carrier shall have an on-time of 1,6 ms and an off-time of 3,4 ms every modulation cycle. The A-line uses sinusoidal continuous wave test signals to emulate the common environment. If the neurostimulator has multiple channels or output modes e.
At tinese low frequencies it is easier to generate a uniform field over a given area. In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: Non-implantable parts of a neurostimulator shall comply ios subclause 6.
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 iiso explains that removable stickers are excluded if they contain information beyond the requirements in this part of ISO Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: General public exposure to magnetic fields represented by the A-line is considered to be probable, frequent and unavoidable.
A consideration for performing the test in saline is the size of the saline isk. If no standards exist, the symbols and colours should be described in the documentation supplied with the implant. The related specifications and characteristics stated by the manufacturer in the accompanying documentation see This information comprises the details on the label and the data in the instructions for use.