ISO is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form. TR and the clauses of this document Annex BB informative Rationale Annex CC informative Injection network example and board layout guidance
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This standard requires implantable medical devices to also comply with ISO testing, specifically Section 27 of the ISO standard. ISO is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. ISO testing is to be carried out on a sample of a device to assess device behavioral responses, and are not intended to be used for the routine testing of manufactured products.
The ISO 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.
Whether or not a neurostimulator is totally or partially implantable, a lead or extension is usually required to convey stimulation pulses from a form of pulse generator to the electrodes, although newer forms of devices might not utilize leads or extensions. An external programmer might be used to adjust device parameters. Not included in the scope of ISO are non-implantable medical devices, such as external neurostimulators and RF-coupled neurostimulators, even though such devices might have implantable parts, because they are covered under the IEC series of standards.
In addition to protecting the patient, the ISO test also aims to protect the active implantable device from the following hazards:. Keystone Compliance is an experienced ISO test lab. Please complete our easy online request a quote form to receive a quote on ISO testing. Search for:. The State of Pennsylvania has deemed Keystone Compliance as an essential life-sustaining company that will remain operational to its customers.
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[Interpretation of the International Standard 2017 Version of Implantable Neurostimulators]