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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Keeping the required lead length to the practical minimum helps keep size and weight manageable. The total area enclosed by a lead of length L in centimetres shall equal: The test setup for the implantable part shall be based on the setup described in In this adopted standard, reference appears to certain International Standards for which Indian Standards also oso.
Place the DUT at the centre of the central plane where the magnetic field is the most uniform. Table — General performance criteria of the DUT for the immunity tests in clause 27 Criterion During test After test Test summary A Operate as intended No loss of function No unintentional responses Operate as intended No loss of function No degradation of performance Conforms to device specs In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: Currently, several types of neurostimulators exist ieo treating the central or peripheral nervous system.
NOTE For magnetic field tests the electrode configuration that is normally the most susceptible is unipolar. PG69 was intended to be written for implantable cardiac devices; parts of the test setup and procedure do not apply and have been modified.
NOTE 4 For implantable parts of an active implantable medical device, all operating instructions are provided in the accompanying documentation. For magnetic fields, the higher immunity test levels have a 10x margin above the lower, common levels and for electric fields there is a 5x margin.
The design should allow easy handling and, where necessary, minimize contamination of the implant by the patient or vice versa during use. These reed switches were usually activated with a magnetic field of around 1 mT. Note 1 — 3. The test is replaced by subclause 7. The higher level of 50 mT Gaussalthough seldom encountered, is a possibility for the genera! Test lead lengths are based on the torso where the majority of implants occur. The use of lEC as a test procedure is consistent with the requirements for non-implantable parts and is a well recognized standard.
A reference sample of similar volume shall be prepared from the same batch of saline, 14708–3 and agitated in a 14780-3 way to the specimen. This Indian Standard has been developed from Doc No.: Optional characterization testing [6. A second level of 50 mT shall be used, applying performance criterion B.
These factors can be 14708- to account for pulsation margins. NOTE 1 Examples of unintended changes are excess charge density, excess voltage, sudden changes in stimulation amplitude and rate runaway. Under this circumstance, the manufacturer is allowed the burden of substantiation. 41708-3 test sample shall be representative of production units and be in normal working condition. Device settings refer, for example, to the rate and pulse width values that were set during the amplitude measurement.
Association for the Advancement of Medical Instrumentation
Likewise, other potential sources of electromagnetic interference exist that can be unseen by patients in their normal environment. The B-line is used for additional assurance of protection from exposure 1470-83 the A-line. Figure 1 of lEC If the lead or extension has multiple conductors, the d. Pulsation and localization effects of electromagnetic fields are taken into account in biological safety standards.
The isso 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 Repeat with the antenna elements parallel to the Y axis.
Repeat X axis and Y axis testing for all frequencies listed in [6. In this environment the device is expected to be free from damage and unacceptable risk.
In addition, a uniform load impedance is specified for comparative purposes. NOTE This subclause is also applicable to rechargeable energy sources. 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. Based on performance results from the tests in Clause 27, it might be necessary to include warning notices in the user documentation.
When perfusion is considered, larger local temperatures increases can be considered.