ISO 14708-3 PDF

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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This allowance has to become the judgment of the manufacturer and regulatory personnel. 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. Specific requirements might be specified in future editions of this part of ISO The result shall be expressed in Hertz Hz. Frequency steps were chosen to cover a representative sample of sources occupying the frequency range.

Information on the geographical origin of the animals should be retained by the manufacturer. 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 connector block area of a typical neurostimulator, with titanium enclosure, is the most susceptible to short wavelength electric fields.

Two test field strengths are used, applying different performance criteria to each. Biological safety standards can be used, for comparative purposes, to assess the potential threat to human safety.

The lower test levels are based on common, everyday exposure conditions. Figure — IPG and lead layout on central plane 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.

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This requirement applies to any part with an energy source that can become depleted, not 17408-3 to implanted parts. NOTE Removable stickers e.

Association for the Advancement of Medical Instrumentation

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.

The tests that are specified in this part of ISO are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products. Pulsation and localization effects of electromagnetic fields are taken into account in biological safety standards.

In this environment the device is expected to be free from damage and unacceptable risk. Excessive current density and the perception of shocking or jolting are examples of potential hazards that might result from unexpected output stimulation changes. General requirements [7] ISO The requirement does not apply to energy sources that cannot be depleted, such as line-powered devices.

These shall be referred to as the A-line and the B- line, respectively, throughout this subclause. The test is performed on one orientation of the DUT as described in Test setup. Search the history of over billion web pages on the Internet. 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.

PG69 was intended to be written for implantable cardiac devices; parts of the test setup and procedure do not apply and have been modified. If not, the uniform area shall be increased until it meets the requirements of this subclause.

Therefore, it is expected that all devices will function normally when in the presence of a 1 mT field. The A-line is intended to represent common, everyday exposure of the general public, to magnetic fields. Modulation requirements are specified in test procedures [8] below.

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NOTE For magnetic field tests the electrode configuration that is normally the most susceptible is unipolar. The excess average count of particles from the specimen compared to the reference sample shall not exceed the amount determined, by the manufacturer, to be hazardous. This part of ISO is also applicable to all non-implantable parts and accessories of the devices as defined in Clause 3.

The upper level is pulse modulated rather than AM primarily due to test facility limitations producing large amplitude fields.

ANSI/AAMI/ISO (PDF)

Any variations in pulse shapes, between channels, output modes, states of operation or load conditions, shall also be described. Test lead lengths are based on the torso where the majority of implants occur. A second level of 50 mT shall be used, applying performance criterion B. The result shall be expressed in volts or milliamperes, as appropriate.

However, based on reference [27] the effective electrical loop area is smaller than the geometric loop area. Room temperature is specified for the test equipment and test sample for convenience. NOTE This subclause is also applicable to rechargeable energy sources. An implantable RF receiver works in tandem with a non-implantable transmitter that is subject to lEC 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.

It is felt that the trial screening device needs to have the same performance and characteristics as the actual neurostimulator.