Search results
Results from the WOW.Com Content Network
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
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.
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.
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Compliance is realized after a product passes a series of tests without occurring some specified mode of failure. Compliance testing for electronic devices include emissions tests, immunity tests, and safety tests. [14] Emissions tests ensure that a product will not emit harmful electromagnetic interference in communication and power lines.
A requirements traceability matrix may be used to check if the current project requirements are being met, and to help in the creation of a request for proposal, [2] software requirements specification, [3] various deliverable documents, and project plan tasks. [4]
A device or system must meet the requirements for both categories to achieve a given SIL. The SIL requirements for hardware safety integrity are based on a probabilistic analysis of the device. In order to achieve a given SIL, the device must meet targets for the maximum probability of dangerous failure and a minimum safe failure fraction.
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]