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Login Join. Subscribe Free Magazine eNewsletter. Active implantable medical devices include technologies like pacemakers, defibrillators, infusion pumps, cochlear implants, and neurostimulators.
Active implantable medical devices AIMDs rely on a source of power other than that provided by the body or gravity, and are intended to be totally or partially introduced into the patient and remain in place. There is a wide range of AIMDs: pacemakers, defibrillators, infusion pumps, cochlear implants, and neurostimulators.
Most AIMDs consist of both the product inserted into the body and non-implantable supporting equipment, both of which require testing and evaluation to medical regulatory standards.
It is important for manufacturers to be familiar with both aspects and the requirements. Devices will not necessarily need to comply with the entirety of this standard family—it will depend on the product type. Part 2: This portion of the standard covers specific requirements for cardiac pacemakers.
It covers devices intended for electrical stimulation of the central or peripheral nervous system. It covers safety requirements that are illustrated via type testing of samples. The standard specifies type tests, animal studies, and clinical evaluation requirements required to show compliance with this standard. Part 6: This section addresses specific requirements for AIMDs intended to treat tachyarrhythmia, including implantable defibrillators.
It includes type test specifications for these products. The requirements of Parts listed above supplement or modify those of Part 1. The requirements of each subsequent part take priority over those of Part 1, as they indicate requirements, procedures, and methods of illustrating compliance specific to their product type.
In addition, each section includes information applicable to non-implantable parts and accessories of the device. This standard covers general requirements for basic safety and essential performance of medical electrical equipment. IEC General requirements for basic safety and essential performance, collateral standard for Usability.
IEC requires compliance to IEC , which covers the application of usability engineering to medical devices. This standard is specific for electromagnetic compatibility EMC of medical electrical devices to ensure their safety and performance in proximity to other electrical products.
A standard that specifies life cycle requirements for the development of medical software and software used within medical devices, it includes provisions for risk management, maintenance, and configuration. This collateral standard covers requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment and should be used for any device intended for home use.
Additionally, many new AIMD systems communicate wirelessly with the implant and other external equipment. These interfaces require additional testing to cover the wireless technology and communication.
Evaluating the implantable and non-implantable equipment simultaneously has several advantages, including savings in time and costs, so manufacturers should consider an approach that incorporates both testing types.
Simultaneous testing allows for economies of scale, as both testing types have requirements around risk management, software, usability, and references to each other.
This will allow for references between reports without having to duplicate efforts, and ultimately a single report package that contains all necessary information for the FDA or notified body. The body can then properly review both the implantable device and the supporting external equipment for a potentially faster release into the market. A design review early in the design cycle to go over the product and process can prevent costly mistakes. Make sure your team reviews the product, considering its intended use, user, environment, and evaluations requirements.
Many issues are quite common and can be resolved easily when it is early in the design. Combatting problems early in the design phase can save costly redesigns and additional testing later, and can allow you to avoid delays to market. AIMDs are complex devices subject to rigorous regulatory standards by authorities across the globe.
With both implantable and non-implantable factors to consider, this means manufacturers have a lengthy list of standards to know and comply with. Keeping them in mind from the beginning design phase and completing evaluations in a timely, cost-effective manner can help bring these devices to markets across the globe. William Stearns is an associate senior engineer at Intertek , a London, U.
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Active Implantable Medical Device Testing: What You Need to Know
ISO specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO are type tests and are to be carried out on samples of an active implantable medical device to show compliance. ISO is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources for example by gas pressure or by springs. ISO is also applicable to some non-implantable parts and accessories of the active implantable medical devices. Check out our FAQs. Buy this standard. CHF Buy.