Foreseeable misuse definition
WebApr 23, 2024 · Foreseeable Misuse” Defined • “use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human … WebMay 31, 2024 · Intended use and “reasonably foreseeable” misuse, along with all device characteristics which impact the safety of the device. Hazards (a potential source of harm*), both known and foreseeable. ... The resulting ISO 14971:2024 definition of harm is “Injury or damage to the health of people, or damage to property or the environment” ...
Foreseeable misuse definition
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WebNote Foreseeable misuse that is warned against in the instructions for use is considered abnormal use if all other reasonable means of risk control have been exhausted. Definition taken from IEC/CD2 60601-1-6:20023. See also Annex A for examples of potential abnormal use. 3.3 Operator: Person handling equipment. WebJan 27, 2024 · The reasonably foreseeable misuse is a new feature presented in ISO 14971:2024, and it is defined as the use of the medical device in a way not intended by the Manufacturer, but which can result from predictable human behaviour, such as use errors, intentional acts of misuse, and use of the medical device for other non-intended medical …
WebMay 1, 2006 · The distinction between abnormal use and reasonably foreseeable misuse is sometimes subtle. One definition is that an action taken by many users can be … WebDefinition: Misuse is a defense used in products liability cases. It means that the plaintiff used the product in a way that was not intended or foreseeable by the manufacturer. Example: If a person uses a hair dryer to dry their pet after a bath and the pet is injured, the manufacturer of the hair dryer may use the defense of misuse.
Webforeseeable adjective [ not gradable ] us / fɔrˈsi·ə·bəl, foʊr-, fər- / able to be understood in advance: Unfortunately, he was likely to remain in power for the foreseeable future (= … WebSep 25, 2024 · The definition of foreseeable use is a very vague legal concept. The reason why the legislator nevertheless takes this into account can best be …
WebDec 7, 2024 · If a reasonable person would recognise the risk associated with the work by applying common sense/knowledge, then it’s reasonably foreseeable. An average person would, for example, recognise the risk …
WebNew Definition. reasonably foreseeable misuse. use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour. state of the art. developed stage of technical capability at a given time as regards products, processes and services, based on the pine valley kennelsWebreasonably foreseeable misuse means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably … h2-ready viessmann kostenWebDefinition: Reasonably foreseeable misuse “Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior” Source: ISO 14971, 3rd edition Such misuse can be intentional or unintentional. Our customers are mainly. Manufacturers of medical devices and medical information … To meet our own quality requirements, we have established a QM system and … As a Dipl. economist and labor economist, Astrid Schulze keeps an overview … Certificates. To meet our own quality requirements, we have established a … pine valley kitchenerWebJun 23, 2024 · Foreseeable misuse that is warned against in the instructions for use is considered abnormal use if all other reasonable means of risk control have been exhausted. See Appendix A for examples of potential abnormal uses. ... If the corrective action meets the definition of a recall, according to the Regulations, then recall reporting ... h2 reseptorin salpaajatWebNOTE Misuse is either reasonably foreseeable misuse (see 2.6) or other misuse such as intentional abuse (see 2.7). 2.5.2 Explanatory information Misuse is any use of the product in a way that is not intended by the manufacturer or which is unlawful. Misuse can either be intentional or unintentional. 2.6 Reasonably foreseeable misuse h2salen melting pointWebreasonably foreseeable misuse means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems; Sample 1 Sample 2 Sample 3 Based on 36 documents reasonably foreseeable misuse means the use of machinery in Sample 1 pine valley kelly ripaWebforeseeable misuse Definition In Annex I No. 1.1.1 of the Equipment Directive, "reasonably foreseeable misuse" is defined as "using machinery in a manner not intended in the directions for use, and which might occur from easily anticipated human behavior." Overview of Foreseeable Misuse pine valley kokomo