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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.
risk assessment (risk identification, risk analysis, risk evaluation) risk treatment; monitoring and review "Risk assessment is the overall process of risk identification, risk analysis and risk evaluation" (ISO 31010) Risk can be assessed at any level of the company’s operations or goals.
For existing safety instrumented systems (SIS) designed and constructed in accordance with codes, standards, or practices prior to the issuance of this standard (e.g. ANSI/ISA 84.01-1996), the owner/operator shall determine and document that the equipment is designed, maintained, inspected, tested, and operated in a safe manner.
The RoHS 2 directive (2011/65/EU) contains allowance to add new materials and 4 materials are highlighted for this attention in the original version, the amendment 2015/863 adds four additional substances to Annex II of 2011/65/EU (3/4 of the new restrictions are recommended for investigation in the original directive, ref Para 10 of preamble).
In essence, each order of magnitude of risk reduction that is required correlates with an increase in SIL, up to a maximum of SIL4. Should the risk assessment establish that the required SIL cannot be achieved by a SIL4 SIF, then alternative arrangements must be designed, such as non-instrumented safeguards (e.g, a pressure relief valve). [1]
ISO 31000 is a set of international standards for risk management.It was developed in November 2009 by International Organization for Standardization. [1] The goal of these standards is to provide a consistent vocabulary and methodology for assessing and managing risk, resolving the historic ambiguities and differences in the ways risk are described.
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]
A drug test (also often toxicology screen or tox screen) is a technical analysis of a biological specimen, for example urine, hair, blood, breath, sweat, or oral fluid/saliva—to determine the presence or absence of specified parent drugs or their metabolites.