ANSI AAMI ISO 16142-2 pdf free download – General essential principles and additional specifc essential principles

ANSI AAMI ISO 16142-2 pdf free download.Medical devices— Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specifc essential principles for all IVD medical devices and guidance on the selection of standards.
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. Every IVD medical device has a use as intended by its manufacturer. An IVD medical device is clinically effective when it provides accurate and reliable information for diagnostic, monitoring or compatibility purposes 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 IVD medical device outweighs the risk of the use to the patient.  It is important to note that it is not possible to ensure an acceptable level of safety and performance in the life-cycle by simply being compliant with one or more standards at one time. A process for continuous compliance is required and the expectation is that this is achieved through the use of a quality management system and a risk management process (this is addressed in the general essential principles, 1 to 6, although the word risk management is not used there). ANSI AAMI ISO 16142-2 pdf download.