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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NOTE This subclause is intended to include implantable parts that depend on a source of electrical energy, such as RF receivers. These factors can be used to account for pulsation margins. For electric fields, susceptibility is usually dependant upon neurostimulator design implementation.
General requirements  ISO Therefore, general public exposure to magnetic fields represented by the B-line is considered to be possible, relatively infrequent sio for short duration when occurring, and generally avoidable when sources are known. Unless the manufacturer can provide sufficient evidence of compatibility a warning statement will be necessary, until such time as standardized test procedures and requirements can be developed for the assessment of device performance and patient safety.
Not all of these components or accessories might be required to be partially or totally implanted, e. 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 20 30 40 50 60 70 isoo 90 1 2 3 4 5 6 7 8 9 10 20 30 NOTE Frequencies are in kHz. Using the following relationship. The requirement does not apply to energy sources that cannot be depleted, such as line-powered devices. General requirement for basic safety and essential performance lEC Performance criteria for optional characterization testing [6.
NOTE isl Not applicable to active implantable medical devices. It is important for the user to understand the stimulation pulse shapes and measurement parameters, such as load. 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. Devices that use electricity to stimulate the nervous system are commonly called neurostimulators. NOTE 2 Configuration refers to the point of measurement and to the model mix of pulse generator, and leads and extensions, if applicable.
Electromagnetic compatibility — Requirements and tests lEC Compliance shall be confirmed by a iiso of the risk management report or equivalent manufacturer’s documents.
Operation of the implantable device, under these exposure conditions, is expected to be normal. 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.
Since this testing is optional, the manufacturer is allowed the discretion to set the performance criteria on which to base these claims. For dated references, only the edition cited applies.
Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition iwo referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: In this way, use of the neurostimulator can be allowed so its clinical benefit can be enjoyed by the patient.
Association for the Advancement of Medical Instrumentation
If the results of a risk assessment or other means e. Specific additional information shall be provided for the following components: If the lead or extension has multiple conductors, the d.
The corresponding Indian Standards which are to be substituted in their respective places are listed below along with their degree of equivalence for the editions indicated: Because some implantable medical devices still depend on reed switch activation for some control features, a change of operational mode would be expected to occur when in the presence of a static magnetic field of greater than 1 mT.
Ten minutes should be a sufficient time to get a response. Figure 1 of lEC In this environment the device is expected to be free from damage and unacceptable risk. Evaluation of test results: Any symbol or identification colour used should conform to International Standards.
The test levels that have been chosen for all the tests are based on general public exposure conditions and, in some cases, are related to biological exposure guidelines. Environment — Section 7: General requirements for basic safety and essential performance lEC There is no localization factor for the electric field.
NOTE Test conditions refer, for example, to ambient temperature and any special circumstances that existed during the measurements.
Specific requirements might be specified in future editions of this part of ISO Depending on proximity and source, field strengths might be higher. The upper level is pulse modulated rather than AM primarily due to test facility limitations producing large amplitude fields.
Using the frequency step method and meeting the minimum step size 17408-3 will result in the frequencies being tested that are listed in Table The test is replaced by 1708-3 7. Particular attention should be paid to the tissues exposed and to the duration and frequency of exposure. The test setup for the implantable part shall be based on the setup described 1470-83 This standard relevant to all parts and accessories of implantable neurostimulators, including programmers, trial screeners, software, and technical manuals.
Functions not associated with essential performance do not need to be tested.