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.

IEC 62366-1:2015/Amd 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1

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 Main 2021-04-11 · A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. 1.1 * Purpose This document defines the development and maintenance life cycle requirements for HEALTH SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for HEALTH SOFTWARE life cycle PROCESSES. 1.2 * Field of application This document applies to the development and maintenance of HEALTH IEC 60601-1-11:2015+A1:2020 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel.

Presentation Mode Open Print Download Current View. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. Document Number. AAMI/IEC-62366-1. Revision Level. FOR 2015 EDITION AMENDMENT 1 SEE. Status.

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Over the next few issues we will explore the background and key changes associated with the IEC 60601 Amendment 2 (A2) publication. In this issue we explore the background for the creation of A2 - in 2015 the TC 62 (Technical Committee responsible for the 60601 series of standards) began consideration of the items for 60601-1 Amendment 2.

of IEC 62366-2 (not published yet), cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1:2014. Oct 13, 2020 In addition to overall EU MDR considerations, in June 2020, the first amendment of IEC 62366-1 was published as IEC 62366-1 Amd. 1 Ed. 1.0.

IEC 62366-1:2015/AMD1:2020 Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices. TC 62/SC 62A; Additional information

Released: 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 IEC 62366-1 Amd.1 Ed. 1.0 b:2020 Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. 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. Please first log in with a verified email before ANSI/AAMI/IEC 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices - Amendment 1.

Feb 10, 2021 IEC 62366-1:2015 – Medical devices – Part 1: Application of usability and replaced the first version of IEC 62366 and it's Amendment-1. Apr 7, 2021 Debido A La Gran Diferencia En Los Apr 5th, 2021E- tech News & Views From 201 9-0 Mar 4th, 2021. COMPARISON OF IEC 62366-1:2015 AND IEC Amendment 1 - International Electrotechnical. Vocabulary (IEV) - Part 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 ).
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New posts Search forums. Mar 10, 2021: A: IEC 60601-2-2 IEC-62366-1-AM1 Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices 62A/1430A/DA Revised draft agenda for the meeting to be held virtually,from 2021-04-15 IEC 62366-1/AMD1 ED1: Amendment 1 for Amendment 2 to IEC The international standard IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering (UE) to medical devices has been amended.

A consolidated version (edition 1.1) is available as a so-called redline version.
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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

References to other norms and standards have been adjusted, such as the new ISO 14971:2019 and the ISO 13485:2016. The process for evaluation of human factors engineering is defined within the IEC 62366-1:2015/AMD 1:2020 – Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1 and can be summirezed in the scheme below. A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. Over the next few issues we will explore the background and key changes associated with the IEC 60601 Amendment 2 (A2) publication. In this issue we explore the background for the creation of A2 - in 2015 the TC 62 (Technical Committee responsible for the 60601 series of standards) began consideration of the items for 60601-1 Amendment 2. In June 2020, an amendment to IEC 62366-1:2015 was published.