Content deleted Content added
GreenC bot (talk | contribs) Reformat 1 archive link. Wayback Medic 2.5 per WP:URLREQ#fda.gov |
|||
(10 intermediate revisions by 8 users not shown) | |||
Line 1:
{{Short description|Testing of prototypes for viability}}
{{For-multi|verification and validation in science and engineering most generally|Verification and validation|test validation|Test validity}}
An '''engineering verification test''' ('''EVT''') is performed on first [[engineering]] [[prototype]]s, to ensure that the basic unit performs to [[design]] goals and [[specifications]].<ref>{{Cite journal |date=2002-08-01 |title=Product news |url=https://doi.org/10.1007/BF02715446 |journal=Practical Failure Analysis |language=en |volume=2 |issue=4 |pages=23–25 |doi=10.1007/BF02715446 |s2cid=195269651 |issn=1864-1245|url-access=subscription }}</ref> Verification ensures that designs meets requirements and specification while validation ensures that created entity meets the user needs and objectives.<ref>{{Cite book |last1=Wang |first1=Der-Wai |last2=Hsu |first2=Yen |title=Cross-Cultural Design. Applications in Business, Communication, Health, Well-being, and Inclusiveness |chapter=A Study of Cross-Cultural Communication in the NPD: Applying Piaget's Theory to Multidisciplinary Communication in the Three Validation Stages |date=2022 |editor-last=Rau |editor-first=Pei-Luen Patrick |chapter-url=https://link.springer.com/chapter/10.1007/978-3-031-06050-2_14 |series=Lecture Notes in Computer Science |volume=13313 |language=en |___location=Cham |publisher=Springer International Publishing |pages=188–201 |doi=10.1007/978-3-031-06050-2_14 |isbn=978-3-031-06050-2}}</ref>
==Tests==
Line 9 ⟶ 11:
* [[Conformance test]]
* [[Electromagnetic interference]] (EMI) pre-scan
* Thermal and
* Basic parametric measurements, specification verification
==Importance==
Identifying design problems
==Prototyping==
Line 19 ⟶ 21:
==Design Verification Test==
Design Verification Test (DVT) is an intensive testing program which is performed to deliver objective, comprehensive testing verifying all product specifications, interface standards, [[original equipment manufacturer|Original Equipment Manufacturer (OEM)
* Functional testing (including [[Usability testing|usability]])
* Performance testing
* Climatic testing
* Reliability testing
* Environmental testing
* [[Mechanical testing]]
* [[Mean time between failures
* [[Conformance testing]]
* Electromagnetic compatibility ([[electromagnetic compatibility
* Safety certification
Line 38 ⟶ 40:
== External links ==
* [https://web.archive.org/web/20190612175636/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers
[[Category:Quality control]]
|