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 the frequency step method and meeting the minimum step size requirements will result in the frequencies being tested that are listed in Table In particular, when stimulating sensory nerves, it is important that the stimulation pulse be stable to prevent unintentional changes in stimulation intensity that might be perceived by the patient as shocking, intermittent stimulation or loss of therapy.
If the service life see 3. PC69 provides rationale for the selection of test frequencies within this range and for test levels. The starting frequency of each decade is, respectively: NOTE 4 For implantable parts of an active implantable isi device, all operating instructions are provided in the accompanying documentation. Both sets of test levels shall be applied to the DUT. However, based on reference  the effective electrical loop area is smaller than the geometric loop area.
The A-line is intended to represent common, everyday exposure of the general public, to magnetic fields. The design should allow easy handling and, where necessary, minimize contamination of the implant by the patient or vice versa during use. Operation of the implantable device, under these exposure conditions, is expected to be free from damage and 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 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9 1 2 3 4 5 6 7 8 9 10 isp 30 40 50 60 70 80 90 1 2 3 4 5 6 7 8 9 10 20 30 NOTE Frequencies are in kHz.
Some degradations are not allowed because of safety concerns and because they are not justified by the severity of the test levels. It is felt that the trial screening device needs to have the same oso and characteristics as the actual neurostimulator. Certain conventions are, however, not identical to those used in Indian Standards.
Exposure to magnetic fields, with the potential to cause disturbances, is primarily from power frequency equipment and appliances. Anthropometric data for a 95th percentile man see references  and  indicates that the longest dimensioned lead in a torso would be placed 1478-3 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.
Test conditions and device settings applicable to the stimulation pulse characteristics stated in the accompanying documentation shall also be stated see The result shall be expressed kso microseconds. PG69 was intended to be written for implantable cardiac devices; parts of the test setup and procedure do not apply and have been modified.
This standard is intended to apply to these neurostimulators types regardless of therapy. General test conditions are described in In theory, the pulsation factor for the electric field could be as high as 32 in persons without implants. The burden of proof is upon the manufacturer to demonstrate via a risk analysis, design analysis, test studies or other appropriate means.
These reed switches were usually activated with a magnetic field of around 1 mT. If the lead or extension has multiple conductors, the d.
Points A and B, as shown in Figure 1 01represent either the direct electrical output of the pulse generator or the electrodes at the distal end of a lead or lead-extension combinationif applicable. If the IPG connector block is orthogonal to the lead then a second test orientation is required that will align the IPG with the polarization of the E-field.
This standard consist of other parts, under the general title ‘Implants for surgery — Active implantable medical devices — Part 1: An implantable RF receiver works in tandem with a non-implantable transmitter that is subject to lEC 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. The sinusoidal carrier shall have an on-time of 1,6 ms and an off-time of 3,4 ms every modulation cycle. Isoo 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: For criterion B, performance degradation, loss of function or unintentional responses are allowed uso no unacceptable risk is created.
This standard relevant to all parts and accessories of implantable neurostimulators, including programmers, trial screeners, software, and technical manuals. Conductive lead placement is as follows see Figure Placing the IPG in the orientation shown in Figure will facilitate testing, as only one orientation of the test setup will need to be exposed to the electric field. Using 144708-3 frequency sweep method or smaller step sizes will result in more frequencies being tested.
The test sample shall be representative of production units, be in normal working condition, and shall not have reached the elective replacement indication see Likewise, other potential sources of electromagnetic interference exist that can be unseen by patients in their normal environment.
Association for the Advancement of Medical Instrumentation
For dated references, only the edition cited applies. Historically, many implantable devices had magnetically activated reed switches internal to the sealed enclosure that were used for control purposes.
Optional characterization testing [6. Compliance shall be checked as specified In lEC This part of ISO is also applicable to all non-implantable parts and accessories of the devices as defined in Clause 3. Environment — Section 5: Most everyday exposure occurs in the home, but it also occurs near power lines, transportation vehicles, office equipment, and in common areas such as school, retail, office and hospital.
Environment — Section 7: If individual packaging of each unit is not practicable, the information should be set out in the leaflet supplied with one or more implants. 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. Both field strengths stated are the levels of the unmodulated test signal.
The B-line is used for additional assurance of protection from exposure above the A-line. Lead length and layout are described in the test setup for each test. CISPR limits for household appliances, electric tools and similar apparatus are lower.