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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Clause 19 of lso This plane shall be called the central plane. The sinusoidal carrier shall have an on-time of 1,6 ms and an off-time of 3,4 ms every modulation cycle. Induction ovens isl electromagnetic interference: Functions not associated with essential performance do not need to be tested.
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. It only needs to be placed in a position that facilitates monitoring of the neurostimulator during the test.
Measurements shall be replicated to characterize operation at minimum, typical and maximum load impedances. The A-line uses sinusoidal continuous wave test signals to emulate the common environment.
Association for the Advancement of Medical Instrumentation
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 isp 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 80 90 1 2 3 4 5 6 7 8 9 10 20 30 NOTE Frequencies ixo in kHz.
The 144708-3 is relaxed at higher frequencies and test levels due to test fixture limitations. The maximum induced voltage comes from a lead loop perpendicular to a magnetic field. The packaging system should be suitable, taking into account the method of sterilization indicated by the manufacturer. Both field strengths stated are the levels of the unmodulated test signal.
According to the rationale in lECamplitude modulation has advantages over other methods. This allowance has to become the judgment of the manufacturer and regulatory personnel. This standard relevant to all parts and accessories of implantable neurostimulators, including programmers, trial screeners, software, and technical manuals.
Performance degradation Loss of function Unintentional responses Operate as intended No loss of function No degradation of performance Conforms to device specs Lost functions shall be self- recoverable In this environment the device is expected to be free from damage and unacceptable risk. Additional contact information shall be provided, e.
These factors can be used 14708–3 account for pulsation margins. No part of these publications may be reproduced in any form without the prior permission in writing of BIS. NOTE A risk assessment can demonstrate 147008-3 a hazard, created as a result of performance degradation, loss of function, or an unintentional response, does not result in an unacceptable risk. PG69 was intended to be written for implantable cardiac devices; parts of the test setup and procedure do not apply and have been modified.
1470-83 — Section 3: The solid line in Figure represents test levels that are subjected to the DUT, applying performance criterion A, as stated in Neurostimulator output can be monitored by using an oscilloscope connected to a sense resistor in series with the lead or by using another lead placed into the saline as a pickup lead.
When perfusion is considered, larger local temperatures increases can be considered. For example, a vertically polarized field would require the DUT to 147008-3 positioned as shown. Recently, certain countries have taken steps to pass legislation controlling source emissions to protect the general public.
This information comprises the details on the label and the data in the instructions for use. This standard 147083- particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system, to provide basic assurance of safety for both patients and users.
For magnetic fields, the higher immunity 147088-3 levels have a 10x margin above the lower, common levels and for electric fields there is a 5x margin. A consideration for 17408-3 the test in saline is the size of the saline tank.
This part of ISO is also applicable to all non-implantable parts and accessories of the devices as defined in Clause 3. NOTE 1 Test conditions refer, for example, to ambient temperature and any special circumstances that existed during the measurements. A second level of 50 mT shall be used, applying performance criterion B. Sources in this category include the higher powered electronic article surveillance EAS gates and higher powered mobile communications equipment.
This standard is intended to apply to these neurostimulators types regardless of therapy. The related specifications and characteristics stated by the manufacturer in the accompanying documentation see Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments. The remainder of the lead side b is kept orthogonal to the electric field in order to minimize an opposite polarity voltage developing across that side.
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. Using the following relationship. The new requirement, referring to lEGwill insure that devices are tested to levels that are currently considered appropriate. The manufacturer shall define the expected duration of the remaining service life following this notice.
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.
Compliance shall be checked by inspection. The manufacturer shall unequivocally state the configuration s that are applicable to the stimulation pulse characteristics stated in the accompanying documentation see All other functions shall comply with the requirements as stated. Information on the geographical origin of the animals should be retained by the manufacturer.
Primary transmitters in this frequency range consist of radiated oscillatory sources which typically are broadcasting transmitters, portable and mobile transmitters and Isp equipment. In addition, other units may be iiso at the manufacturer’s discretion. Electromagnetic compatibility — Requirements and tests lEC In addition, other units can be used if the manufacturer chooses.
Excessive current density and the perception of shocking or jolting are examples of potential hazards that might result from unexpected output stimulation changes. Standards are also reviewed periodically; a standard along with amendments is 144708-3 when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision.