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ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
The tolerable level of these risks is specified as a safety requirement in the form of a target 'probability of a dangerous failure' in a given period of time, stated as a discrete SIL. Certification schemes, such as the CASS Scheme (Conformity Assessment of Safety-related Systems) are used to establish whether a device meets a particular SIL. [4]
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7, 1996. [4]
ISO 16142 Medical devices – Recognized essential principles of safety and performance of medical devices ISO 16142-1:2016 Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]