ANSI AAMI ISO 16142-1 pdf free download – non-IVD medical devices and guidance on the selection of standards
ANSI AAMI ISO 16142-1 pdf free download.Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specifc essential principles for all non-IVD medical devices and guidance on the selection of standards.
4 Essential principles of safety and performance of medical devices
Medical device standards developers are encouraged to consider the essential principles as design input for the development of new and revised medical device standards. Additional information is found in Annex D.
Medical device performance can include technical functions in addition to clinical effectiveness. Performance is easier to objectively measure and quantify than clinical effectiveness. Performance may be described as how well or accurately a medical device carries out its use(s) as intended by its manufacturer. For some medical devices, medical benefit or clinical effectiveness can only be determined by conducting clinical investigations carried out in human subjects.
The manufacturer of a medical device is expected to design and manufacture a product that is safe and clinically effective throughout its life-cycle. This part of ISO 16142 describes fundamental design and manufacturing criteria, referred to as essential principles of safety and performance, to ensure this outcome. This part of ISO 16142 is structured to provide general essential principles that apply to all medical devices including IVD medical devices. This part of ISO 16142 also includes additional essential principles of safety and performance which are relevant to medical devices other than IVD medical devices that need to be considered during the design and manufacturing process.
Essential principles of safety and performance provide broad, high-level, criteria for design, production, and post- production (including post-market surveillance) throughout the life-cycle of all medical devices, ensuring their safety and performance. The concept of essential principles was developed by the Global Harmonization Task Force151. The concept is intended to encourage convergence in the evolution of regulatory systems for medical devices.
NOTE Some authorities with jurisdiction have more requirements and some have less. Therefore, manufacturers need to understand the requirements of the authorities having jurisdiction in the markets they intend to se rye.
Where relevant, to ensure all of the essential principles are met, a manufacturer may use consensus standards that contain detailed requirements demonstrating conformance with the essential principles. Such consensus standards provide a greater level of detail and specificity than can be expressed in the essential principles. Equally, authorities having jurisdiction may find the essential principles and their related standards useful in the fulfilment of pre-market and post-market requirements throughout the life-cycle of medical devices.
Every medical device has a use as intended by its manufacturer. A medical device is clinically effective when it produces the effect or performs the function in a safe manner as intended by its manufacturer relative to
— the medical condition of the patient, or
— the state of the patient where the medical benefits of the use of the medical device outweighs the risk of the use to the patient.
Process standards can be either horizontal or vertical in nature and provide the requirements for manufacturers to develop, implement, and maintain processes applicable to all stages of the life-cycle of a medical device. Quality management system standards and risk management standards are good examples of process standards within the group standards type. Operation or maintenance of defibrillator standards are good examples of process standards within the product standards type. Because the focus can change at various points within the life-cycle of any given medical device, process standards are routinely developed both as group or product standards.ANSI AAMI ISO 16142-1 pdf download.
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ANSI AAMI ISO 16142-2 pdf free download – General essential principles and additional specifc essential principles
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