ISO 14971:2019 pdf download Medical devices — Application of risk management to medical devices
Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but could involveauditory, visual, or tactile materials and multiple media types.
3.2
benefit
positive impact or desirable outcome of the use of a medical device (3.10) on the health of an individualor a positive impact on patient management or public health
Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomerelated to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact orpublic health.
3.3
harminjury or damage to the health of people, or damage to property or the environmentSOURCE:ISO/1EC Guide 63:2019,3.1
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hazard
potential source of harm (3.3)
SOURCE:ISO/1EC Guide 63:2019,3.2
3.5
hazardous situationcircumstance in which people, property or the environment is/are exposed to one or more hazards (3.4Note 1 to entry: See Annex C for an explanation of the relationship between hazard and hazardous situation.
SOURCE: ISO/IEC Guide 63:2019,3.3, modified – Note 1 to entry added.
36
intended use
intended purpose
use for which a product,process (3.14) or service is intended according to the pecifications,instructionsand information provided by the manufacturer (3.9)
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interactedwith, user profile, use environment, and operating principle are typical elements of the intended use.
[SOURCE:ISO/IEC Guide 63:2019,3.4
3.7
in vitro diagnostic medical device
IVD medical devicedevice, whether used alone or in combination, intended by the manufacturer (39) for the in vitroexamination of specimens derived from the human body solely or principally to provide information fordiagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materialsspecimen receptacles, software, and related instruments or apparatus or other articles
SOURCE:ISO 18113-1:2009,3.27,modified -NOTE deleted.]
3.8
life cycle
series of all phases in the life of a medical device (3.10), from the initial conception to finaldecommissioning and disposal
[SOURCE: SO/IEC Guide 63:2019,3.5]

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