informations à fournir par le fabricant. STANDARD. ISO. Second edition . Reference number. ISO (E). Provläsningsexemplar. ISO Implants for Surgery – Active Implantable Medical Devices – Part 1: General Requirements for Safety, Marking and for Information to be Provided. It is most important that the objectives and potential uses of an. AAMI product standard or recommended practice are clearly understood. The objectives of.
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Subscribe Free Magazine eNewsletter. Active implantable medical devices include technologies like pacemakers, defibrillators, infusion pumps, cochlear implants, and 147081.
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: 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.
Lists of National 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.
Here is an overview of the different sections: This standard specifies general requirements for AIMDs to provide basic assurance of safety for patients and users. This portion of the standard covers specific requirements for cardiac pacemakers. This section covers the requirements for implantable neurostimulators, to provide basic assurance of safety for both patients and users.
It covers devices intended for electrical stimulation of the central or peripheral nervous system. Part 3 aligns with ISO Specific requirements for implantable infusion pumps, devices intended to deliver medicinal substances to site-specific locations within the human body. It covers safety requirements that are illustrated via type testing of samples.
This section applies to circulatory support devices, excluding intra-aortic balloon pumps, external corporeal perfusion devices, and cardiomyoplasty. The standard specifies type tests, animal studies, and clinical evaluation requirements required to show compliance with this standard.
This section addresses specific requirements for AIMDs intended to 14078-1 tachyarrhythmia, including implantable defibrillators. This standard specifies requirements applicable to AIMDs intended to treat hearing impairment via electrical stimulation of the auditory pathways, also known as cochlear implant systems.
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 1408-1, 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.
Under Part 1 of ISO for AIMDs, non-implantable supporting equipment must be evaluated to the specifications to certain electrical standards, including: This standard covers general requirements for basic safety and essential performance of medical electrical equipment. General requirements for basic safety and essential performance, collateral standard for Usability. IEC requires compliance to IECwhich 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.
Active Implantable Medical Device Testing: What You Need To Know – Medical Product Outsourcing
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.
Active Implantable Medical Device Testing: What You Need to Know
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 is can be resolved easily when it is early in the design. Combatting problems early 147708-1 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.
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