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SK EN 62366:2015

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SK EN 62366:2015
Status: Withdrawn
Gjuha: English
Faqe: 114
Publikuar: 2015-11-16
I tërhequr: 2024-02-27
Regjistri Kombëtar: 141/2015
Botim:
Standardet ndërkombëtare që kanë lidhje
This standard is identical to:
EN 62366:2008
CLC/TC 62
Çmim: 51 €



Titulli Shqip

Pajisje mjekësore - Zbatim i teknikës së përdorimit për pajisjet mjekësore

Titulli Anglisht

Medical devices - Application of usability engineering to medical devices

Scope Shqip

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Scope Anglisht

Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.

Komitetet Teknike

ICS

Direktivë

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Veprim Kombëtar

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