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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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IEC 62366 - Medical Device Usability Engineering
Application of usability (human factors engineering) engineering to medical devices.
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Sticky
What do you think the revision of IEC 62366 should bring?
Marcelo
Jan 17, 2012
2
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16
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11,226
Apr 22, 2015
Marcelo
Discussions
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European Harmonized vs IEC standard
Balamurugan B
Apr 9, 2021
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2
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151
Apr 9, 2021
Balamurugan B
J
IEC 62366 - Summative Evaluation
Julie_
Jul 16, 2018
Replies
6
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1,947
Mar 16, 2021
HenkP
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Usability for custom made medical devices
Koskis
Jan 11, 2021
Replies
5
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660
Feb 1, 2021
Koskis
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How do Functions & Tasks differ?
ThatSinc
Nov 17, 2020
2
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13
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929
Jan 13, 2021
Tidge
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User Interface of Unknown Provenance (UOUP) applicability
MEDevic
Oct 30, 2017
Replies
8
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5,093
Jan 6, 2021
FrozenJay
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Does anyone have experience with EN ISO 17664 ?
zeypzeyn
Oct 27, 2020
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9
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825
Nov 19, 2020
monoj mon
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Primary Operating Functions (POF) in IEC 62366-1:2015.
Koskis
Jan 31, 2020
Replies
7
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2,189
Oct 20, 2020
Tidge
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Assessing Hazard-Related Use Scenarios where control measures exist through standards
ThatSinc
Apr 22, 2020
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4
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32
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3,092
Oct 2, 2020
ThatSinc
Amendment 1 of IEC 62366-1 - Details yet?
adir88
Mar 2, 2020
Replies
2
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1,663
Aug 18, 2020
adir88
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Identification of hazards and Risk file
Koskis
Apr 5, 2020
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1,173
Apr 20, 2020
ThatSinc
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Applicability of IEC 62366-1 usability to resorbable bone substitutes
Ventura
Dec 16, 2019
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9
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1,479
Jan 20, 2020
Tobias_HF
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IEC 60601-1-6 last release or IEC 62366?
aeropel
Jan 10, 2012
2
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17
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12,876
Oct 23, 2019
Belen Sanchez
Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6
pashah
Sep 9, 2019
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4
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2,571
Sep 10, 2019
pashah
C
Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach
cam5603
May 2, 2019
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1,949
May 2, 2019
Ronen E
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IEC 62366 and Medical Device Usability Validation
zinzibars
Dec 15, 2013
2
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10
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7,716
Mar 7, 2019
Tobias_HF
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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