ANSI AAMI ISO 16142-2:2017 pdf download – Medical devices – Recognized essential principles of safety and performance of medical devices
1 Scope
This document, 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 document identifies and describes the six general essential principles of safety and performance (see Table B.1 ) that apply to all medical devices, including IVD medical devices (in vitro diagnostic). This document 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 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 document 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 IVD medical devices
IVD medical device standards developers are encouraged to consider the essential principles as design input for the development of new and revised IVD medical device standards. Additional information is found in Annex D. IVD 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 an IVD medical device carries out its use(s) as intended by its manufacturer. For some IVD medical devices, medical benefit or clinical effectiveness can only be determined by conducting clinical performance studies carried out in human subjects. The manufacturer of an IVD medical device is expected to design and manufacture a product that is safe and clinically effective throughout its life-cycle. This document describes fundamental design and manufacturing criteria, referred to as essential principles of safety and performance, to ensure this outcome. This document is structured to provide general essential principles that apply to all medical devices including IVD medical devices. This document also includes additional essential principles of safety and performance which are relevant to 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 IVD medical devices, ensuring their safety and performance. The concept of essential principles was developed by Study Group 1 of the Global Harmonization Task Force [5] . The concept is intended to encourage convergence in the evolution of regulatory systems for IVD medical devices. NOTE Some authorities having 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 serve.