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 test sample shall be representative of production units and be in normal working condition. Replaces the former, and less comprehensive, requirement of using a single technique, such as FMEA.
Retesting the A-line at frequencies exhibiting a pulse modulation effect provides an additional assurance of safety. Room temperature is specified for the test equipment and test sample for convenience. isso
Association for the Advancement of Medical Instrumentation
The sinusoidal carrier will have an on-time of 1 ms and an off-time of isi ms every modulation cycle. The remainder of the lead is placed along side b. Using the frequency sweep method or smaller step sizes will result in more frequencies being tested.
Biological safety standards can be used, for comparative purposes, to assess the potential threat to human safety. The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard.
Any ancillary equipment that is needed to operate the neurostimulator or monitor its output during the test shall, as much as possible, be selected and located to minimize disruption of the uniform field. Keeping the required lead length to the practical minimum helps keep size and weight manageable.
Non-implantable parts of a neurostimulator shall comply with subclause 6. 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. This standard specifies 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.
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. Place the DUT at the centre of the central plane where the magnetic field is the most uniform.
It should be possible to read this code, if necessary, without the need for a surgical operation. Sources with field strengths high enough to cause potential interference with implanted medical devices consist primarily of hand-held wireless transmitters e. The lower test levels are based on common, everyday exposure conditions.
The uniform field shall exist over an area of radius 7,5 cm minimum that lies on a plane parallel to the coil s. By “risks during normal conditions and fault conditions” are meant those risks which have been determined by a risk analysis. Other orientations present such a small device profile it is unlikely to see interactions not seen with the required ixo.
The test is performed on one orientation of the DUT as described in Test setup. If not, the uniform area shall be increased until it meets the requirements of this subclause. Particular attention should be paid to implants whose intended use includes exposure to flammable substances or to substances which could cause combustion. Operation of the implantable device, under these exposure conditions, is expected to be free from damage and unacceptable risk.
Specific requirements might be specified in future editions of this part of ISO Note 2 The instructions for use should also include details allowing the medical staff to brief the patient on any contra- indications and any precautions to be 144708-3.
General requirements for safety, marking and for Information 14780-3 be provided by the manufacturer I EC The number of drops for patient-carried parts that are hand-held shall be three from each of three different starting orientations encountered during normal use see subclause Sources in this category include the higher powered electronic article surveillance EAS gates and higher powered mobile communications equipment.
In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: A consideration for performing the test in saline is the size of the saline tank. The B-line is used for additional assurance of protection from exposure above the A-line.
More complex impedances may be used if they better represent actual use. If the service life see 3. Two test field strengths are used, applying different performance criteria ixo each. 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.
Side a will be oriented in the direction of the electric field. Exposure to magnetic fields, with the potential to cause disturbances, is primarily from power frequency equipment and appliances. Operation of the implantable device, under these exposure conditions, is expected to be normal. This does not preclude the free use, in course of imple- menting the standard, of necessary details, such as symbols and sizes, type or grade designations.
Functions not associated with essential performance do not need to be tested. Some degradations are not allowed because of safety concerns and because they are not justified by the severity of the test levels. The exclusion band shall not be larger than normally required for the telemetry function to operate as intended.
NOTE Test conditions refer, for example, to ambient temperature and any special circumstances that existed during the measurements. NOTE 3 Not applicable because