62A/1397/RVD Result of Voting on 62A/1386/FDIS - IEC 62366-1/AMD1 ED1: Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices 444 kB 2020-05-08

Several amendments to the text of the international standard IEC 62366-1: Application of usability engineering to medical devices have been published in June 2020. This standard drives much of the usability engineering work done by Emergo by UL’s Human Factors Research & Design (HFR&D) team.

Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020) Newest version Valid from 17.08.2020 Amendment Jun 17, 2020 This consolidated version consists of the first edition (2015) and its amendment 1 (2020). Therefore, no need to order amendment in addition to IEC 62366-1 Amd.1 Ed. 1.0 b:2020, First Edition: Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices [International (Consolidated Text), Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1. The amendment included in this The amendment had published one major aspect of the IEC 62366-1:2015 standard in advance, namely the handling of user interfaces of unknown provenance ( Jun 30, 2015 This amended standard replaces BS EN 62366-1:2015 .

Iec 62366-1 amendment 2021

Document Number. AAMI/IEC-62366-1. Revision Level. FOR 2015 EDITION AMENDMENT 1 SEE. Status. Superseded. Publication Date. Aug. 14, 2020 Amendment 1 (2020-06) to the IEC 62366-1 standard for Usability Engineering published.

IEC 62366-1 : Medical devices – Part 1: Application of usability engineering to IEC 62366-1 1.1 Edition, June 2020 IEC 62366-1 ( Amendment Only ).

This article identifies the changes made to the standard as well as their potential impact. Wording Changes.

Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices Designation: IEC 62366-1:2015/AMD1:2020 Status: Published Published: 2020 Committee: IEC/TC 62/SC 62A (Common aspects of electrical equipment used in medical practice) Product Type: Standard

This standard drives much of the usability engineering work done by Emergo by UL’s Human Factors Research & Design (HFR&D) team. EN 62366-1:2015/A1:2020,IEC 62366-1:2015/AMD1:2020: Amended By: Amendment, August 2020; Corrigendum, January 2016: Draft Superseded By: 18/30359002 DC: Descriptors: Hazards, Medical technology, Ergonomics, Instructions for use, Equipment safety, Design, Medical equipment, Medical instruments : ICS: 11.040 11.040.01: Title in French Amendement 1 - Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux.

TC 62/SC 62A; Additional information; Note: a consolidated version of this publication exists IEC 62366-1:2015+AMD1:2020 CSV Framtagen av: IEC . Internationell titel: Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices. Artikelnummer: STD-80022652. Utgåva: 1. Fastställd: 2020-06-17. Antal sidor: 38. Tillägg till: IEC 62366-1:2015 ISO - IEC 62366-1:2015/Amd 1:2020 - Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1.
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It was hoped that IEC 62304 2 nd edition would have been published but that edition had issues in committee and has not yet been published.

The amendment included in this consolidated version of ANSI/AAMI/IEC 62366-1:2015 and ANSI/AAMI/IEC 62366-1:2015/A1:2020 corrects identified inaccuracies in ANSI/AAMI/IEC 62366-1:2015 while making no fundamental changes to the usability engineering process as originally conceived in that document.
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IEC 62366-1:2015/Amd 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1

Se hela listan på johner-institut.de IEC 62366-1:2015/DAmd 1(en) Medical devices ? Part 1: Application of usability engineering to medical devices AMENDMENT 1.