ANSI AAMI ISO 16142-2-2017 pdf download
ANSI AAMI ISO 16142-2-2017 pdf download.Medical devices—Recognized essential principles of safety and performance of medical devices
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. 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 premarket and post-market requirements throughout the life-cycle of IVD medical devices.
5 Use of standards and guides in support of the essential principles
5.1 General approach to using standards
The essential principles of safety and performance are the general, high-level criteria that when met indicate that an IVD medical device is safe and effective. Regulatory requirements expect that an IVD medical device be safe and effective during its life-cycle and so conformity with the essential principles of safety and performance must be achieved throughout the life-cycle of the IVD medical device. For the IVD medical device manufacturer, this usually means that their IVD medical device complies with the essential principles and must be
a) designed to be safe and effective,
b) manufactured to maintain the design characteristics,
c) used in a way that maintains the design characteristics, and
d) in the post-production phase, reviewed to evaluate the production and post-production information for relevancy to safety and performance, in which case, a design change might be needed to make the IVD medical device compliant again with the essential principles.
