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 standard relevant to io parts and accessories of implantable neurostimulators, including programmers, trial screeners, software, and technical manuals. Compliance shall be confirmed by a review of the risk management report or equivalent manufacturer’s documents. Two test field strengths are used, applying different performance criteria to each. The result shall be expressed in volts or milliamperes, as appropriate.
It is important for the user to understand the stimulation pulse shapes and measurement parameters, such as load. Information on the geographical origin of the animals should be retained by the manufacturer. Biological safety standards can be used, for comparative purposes, to assess the potential threat 1478-3 human safety. The sinusoidal carrier shall have an on-time of 1,6 ms and an off-time of 3,4 ms every modulation cycle.
Electromagnetic interference that the patient should avoid or be aware of, as a result of DUT performance during these immunity tests, shall be described in the accompanying documentation see Other orientations present such a small device profile it is unlikely to see interactions not seen with the required orientation.
Attention is particularly drawn to the following: Test lead lengths are based on the torso where the majority of implants occur. The sinusoidal carrier will have an on-time of 1 ms and an off-time of 4 isso every modulation cycle.
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. The use of lEC as 147083 test procedure is consistent with the requirements for non-implantable parts and is a well recognized standard.
The threat from hand-held wireless devices is higher than from other far field broadcast media e. It is felt that the trial screening 147088-3 needs to have the same performance and characteristics as the actual neurostimulator. The upper level is pulse modulated rather than AM primarily due to test facility limitations producing large amplitude fields. For example, if a lead is 85 cm in length, the length of side a would be 53 cm.
PC69 provides rationale for the selection of test frequencies within this range and for test levels. PG69 was intended to be written for implantable cardiac devices; parts of the test setup and procedure do not apply and have been modified. This part of ISO is also applicable to all non-implantable parts and accessories of the devices as defined in Clause 3. Device settings refer, for example, to the rate and pulse width values that were set during the amplitude measurement.
Non-implantable parts of a neurostimulator shall comply with subclause 6.
Association for the Advancement of Medical Instrumentation
Performance degradation Loss of function Unintentional responses Operate as intended No loss of function No degradation of performance Conforms to device specs Lost functions shall be self- recoverable NOTE Removable stickers e.
Operation of the implantable device, under these exposure conditions, is expected to be free from damage and unacceptable risk.
The test documentation shall state the function and mode used. The new requirement, referring to lEGwill insure that devices are tested to levels that are currently considered appropriate. 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. Retesting the A-line at frequencies exhibiting a pulse modulation effect provides an additional assurance of safety.
The maximum induced voltage comes from a lead loop perpendicular to a magnetic field. NOTE A risk assessment can demonstrate that a hazard, created as a result of performance degradation, loss of function, or an unintentional response, does not result in an unacceptable risk. Requirements related to signal injection and parameter programming, as used in PC69, are not applicable.
Optional characterization testing [6. 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 taken.
Processing, reservation, testing and handling of tissues, cells and substances of animal origin should be carried out so as to provide optimal security. The number of drops for patient-carried parts that are hand-held shall be three from each kso three different starting orientations encountered during normal use see subclause In addition, a uniform load impedance is specified for comparative purposes.
Certain conventions are, however, iao identical to those used in Indian Standards. Conductive lead placement is as follows see Figure Lead placement exposes the longest practical dimension of a lead placed in the torso, to a parallel electric field polarization. The test 14708–3 shall be representative of production units, be in normal working condition, and shall not have reached the elective replacement indication see 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.
General requirements for sefety, marking and for information to be provided by the manufacturer’. It is very important that the patient and physician understand the risks involved with implantable devices. A formula that can be used for this approximation is given in formula NOTE 3 Not applicable because In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: The data in the figure 14708-33 account for localization iwo based on homogeneity of source field including size and proximity according to lEC ].
No part of these publications may be reproduced in any form without the prior permission in writing of Ido. If the implants are intended to administer medicinal products they should be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and 41708-3 that their performance is maintained in accordance with the intended use.