Cover E DIN EN 62366-1/A1 VDE 0750-241-1/A1:2019-04
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E DIN EN 62366-1/A1 VDE 0750-241-1/A1:2019-04

* German Language Version *

Medical devices

Part 1: Application of usability engineering to medical devices

(IEC 62A/1288/CDV:2018); German and English version EN 62366-1:2015/prA1:2018
Class/Status: Draft, valid
Released: 2019-04   Published: 2019-03-15
VDE Art. No.: 1701449
End of objection deadline: 2019-05-15

The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified and presented to the National Committee members of IEC/SC 62A and to the Member Bodies of ISO/TC 210. A majority of the members of both committees that stated a position supported developing this amendment to address the identified issues while making no fundamental changes to the usability engineering process as originally conceived in IEC 62366-1:2015.

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Entwicklung und Herstellung medizinischer Software
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