ANSI AAMI ISO 16142-1:2016 pdf download – Medical devices – Recognized essential principles of safety and performance of medical devices

03-12-2022 comment

ANSI AAMI ISO 16142-1:2016 pdf download – Medical devices – Recognized essential principles of safety and performance of medical devices
1 Scope
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). This part of ISO 16142 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices. Future ISO 16142-2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of IVD medical devices. NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others. This part of ISO 16142 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
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 Force [5] . 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.

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