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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The starting frequency of each decade is, respectively: NOTE 5 In the general case, warnings and precautions, except for those dealing with special handling conditions [see 4. A second level of 147083- mT shall be used, applying performance criterion B.
The plane of the largest surface area of the DUT is placed parallel to the central plane this exposes the neurostimulator’s largest surface to the primary magnetic flux lines which are perpendicular to the central plane.
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.
Users of Indian Standards should ascertain that they are in 147008-3 of the latest amendments or edition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Induction ovens and electromagnetic interference: Based on performance results from the tests in Clause 27, it might be necessary to include warning notices in the user documentation.
Devices that use electricity to stimulate the nervous system are commonly called neurostimulators. It is appropriate to use the lEC standard methodology due to the similarity of the electromagnetic environmental exposure encountered by external and implantable medical devices.
The dwell time at each step shall be long enough for the DUT to adequately respond to the test signal, but not less than 15 s. Keep the IPG in the same position for all tests. The exposure duration shall be long enough for the DUT to adequately respond to the test 14708–3, but not less than 15 isp. Any part of the implantable neurostimulator, intended in normal use to be in contact with body fluids, shall be evaluated to determine if the release of particulate matter is hazardous.
Some degradations are not allowed because of safety concerns and because they are not justified by the severity of the test levels.
Clause 24 is also harmonized with Clause 5. Therefore, it is expected that all devices will function normally when in the presence of a 1 mT field. This formula is valid for a semi-circle and will have to izo applied accordingly. In addition, other units may be used at the manufacturer’s discretion.
Association for the Advancement of Medical Instrumentation
NOTE 1 Examples of unintended changes are excess charge density, excess voltage, sudden changes in stimulation amplitude and rate runaway. The load impedances used to obtain the stimulation pulse characteristics stated in the accompanying documentation see Lead placement 41708-3 the longest practical dimension of a lead placed in the torso, to a parallel electric field polarization. The number of significant places retained in the rounded off value should be the same as that of uso specified value in this standard.
The use of lEC as a test procedure is consistent with the requirements for non-implantable parts iao is a well recognized standard. Not all parts or accessories might be intended to be totally or partially implanted, but there is need to specify some requirements of non-implantable parts and accessories, if they could affect the safety or performance intended by the manufacturer. The results shall be expressed in ohms.
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. The result 147083- be expressed in microseconds. For magnetic fields, the higher immunity test levels have a 10x margin uso the lower, common levels and for electric fields there is a 5x margin.
For example, if a lead is 85 cm in length, the length of side a 144708-3 be 53 cm. If the service life see 3. This part 14708-33 ISO allows the manufacturer to define the requirements for particulate matter that can be different depending on the intended neurostimulator application. Therefore, in this environment, it is reasonable to expect that an implantable neurostimulator would work completely as intended, with no loss of function and without any unintentional responses.
PC69 provides rationale 14780-3 the selection of test frequencies within this range and for test levels. Electromagnetic compatibility — Requirements and tests lEC Exposure to magnetic fields, with the potential to cause disturbances, is primarily from power frequency equipment and appliances.
Test lead lengths are based on the torso where the majority of implants occur. This illustration is based on the frequency step method using minimum required step sizes. Compliance shall be checked by inspection. The data in the figure already account for localization effects based on homogeneity of source field including size and proximity according to lEC ].
There is a 3x margin above the kso known EAS gate and a 5x margin above typical worst case mobile transceivers. Test levels vary depending on frequency and performance criteria [see The total area enclosed by a lead of length L in centimetres shall equal: Static magnetic field strengths, right on the surface jso common household magnets e. The following degradations are not allowed: Consequentiy, tinere are aiso two defined sets of performance criteria a tinird criterion level is defined by the manufacturer.