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.
|Published (Last):||5 September 2013|
|PDF File Size:||4.25 Mb|
|ePub File Size:||4.20 Mb|
|Price:||Free* [*Free Regsitration Required]|
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 maximum induced voltage comes from a lead loop perpendicular to a magnetic field.
Association for the Advancement of Medical Instrumentation
Extraordinary device behaviour is not expected to occur typically, and the 10x test levels should verify this experimentally. It should be possible to read this code, if necessary, without the need for a surgical operation. Although the manufacturer is not required to use this method, it can be used to confirm the manufacturer’s measurement or calculation and should agree within a reasonable amount.
For example, a vertically polarized field would require the DUT to be positioned as shown. Insulating parts of implantable leads or extensions that incorporate electrical conductors shall be designed to withstand the electrical stresses placed on the insulation in normal working conditions over the planned lifetime of the product.
This formula is valid for a semi-circle and will have to be applied accordingly.
The test documentation shall state the function and mode used. The use of lEC as a test procedure is consistent with the requirements for non-implantable parts and is a well recognized standard. Processing, reservation, testing and handling of tissues, cells and substances of animal origin should be carried out so as to provide optimal security.
This allowance has to become the judgment of the manufacturer and regulatory personnel. Any part of the implantable neurostimulator, intended in normal use to be in contact with body sio, shall be evaluated to determine if the release of particulate matter is hazardous. Test conditions applicable to the lead or extension d. Likewise, other potential sources of electromagnetic interference exist that can be unseen by patients in their normal environment.
Optional characterization testing [6. For most test setups a uniform area of radius 7,5 cm will be large enough to cover the DUT. Figure 1 of lEC Non-implantable parts of neurostimulators shall comply with subclause The actual rate is calculated from the reciprocal of the interval measurement. General requirements  ISO By “risks during normal conditions and fault conditions” are meant those risks which have been determined by a risk 147708-3.
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. The limits presented in these standards can be used as a guideline for setting immunity test levels based on the presumption that public exposure to electromagnetic fields should be limited.
When perfusion is considered, larger local temperatures increases can be considered. The manufacturer shall unequivocally state the configuration s that are applicable to the stimulation pulse characteristics stated in the accompanying documentation see The wet rub test is replaced by subclause 7.
The higher level of 50 mT Ispalthough seldom encountered, is a possibility for the genera! 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: The modulation rate is Hz which is close to the physiological passband and avoids power line frequencies and typical stimulation rates.
The new requirement, referring to lEGwill 144708-3 that devices are tested to levels that are currently considered appropriate. 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 number of significant places retained in the rounded off value should be the same as that of the specified value in this standard. Since every conceivable situation cannot be foreseen, an allowance is made for temporary degradation of performance and unintentional responses as long as patient safety is maintained.
This part of ISO allows the manufacturer to define the requirements for particulate matter that can be different depending on the intended neurostimulator application. Replaces the former, and less comprehensive, requirement of using a single technique, such as FMEA.
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. The lead length was chosen from anthropometric data for a 95th percentile man see references  and [ 26] which indicates that the longest dimensioned lead in a torso would be placed abdominally 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.
What is the risk for patients with implanted pacemakers? This standard relevant to all parts and accessories of implantable neurostimulators, including programmers, trial screeners, software, and technical manuals. If the results of a risk assessment or other means e. Currently, several types of neurostimulators exist for treating the central or peripheral nervous system. Step sizes as specified give reasonable coverage of the frequency range without creating a burdensome number of test measurements.
NOTE This subclause is intended to include implantable parts that depend on a source of electrical energy, such as RF receivers. Other orientations present such a small device profile it is unlikely to see interactions not seen with the required isl. It only needs to be placed in a position that facilitates monitoring of the neurostimulator during the test.