The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices. It is harmonized by the European Union (EU) and the United States, and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

11. 4 Mapping between the requirements of IEC 62366-1 and the guidance of. IEC TR 62366-2 .. 14. 5 Background and justification of the USABILITY ENGINEERING program 14.

DS/EN 62366-1:2015 I.S. EN 62366-1:2015. Superseded View Superseded By. Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard. For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal. Usability and ergonomics have become important quality and performance features of medical devices. The two standards EN 62366-1 and EN 60601-1-6 are harmonized under the Medical Device Directive (93/42/EEC and 98/79/EC) and describe how the usability requirements are to be considered in the development process of medical devices.

ISO 13485 driven application life cycle management (ALM) for medical device software, hardware and firmware development. Aligned Elements facilitates medical device developments according to industry norms and regulations such as ISO 14971, IEC 62304, IEC 60101-1, IEC 62366, MDD 93/42/EEC, IVDD 98/79/EC, FDA 21 CFR Part 820 and FDA 21 CFR Part 11. IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified) CISPR 11 NOTE Harmonized as EN 55011 . BS EN IEC 60601-2-66:2020. The EN IEC 62366:2008 and 2015 are harmonized standard. The EU recognizes EN 62366:2008.

evs-en 62366:2008 Medical devices – Application of usability engineering to medical devices General information

In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1:2005 . NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/A1:2012 I.S. EN 62366-1:2015. Superseded View Superseded By. Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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.

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.

Das Ziel des Konzepts besteht darin, für „Legacy-Benutzerschnittstellen“ eine Vereinfachung zu ermöglichen, ggf. sogar auf einen Usability Engineering Prozess zu verzichten. BS EN 62366-1:2015+A1:2020: Title: Medical devices. Application of usability engineering to medical devices: Status: Current: Publication Date: 30 June 2015: Normative References(Required to achieve compliance to this standard) EN ISO 14971:2019, ISO 14971:2019, EN ISO 14971:2012, ISO 14971:2007: Informative References(Provided for Information) Add to this that IEC 62366-1 should be referenced in the list of harmonized standards sooner or later. Thus there’s really no use to continue applying IEC 62366:2007 for new designs.
Marek keller

Regulation and implementation of usability engineering for a medical device MelissaHolopainen School of Science Thesis submitted for examination for the degree of This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”.

Medicintekniska produkter - Tillämpning av metoder för att säkerställa medicintekniska produkters användarvänlighet. Prenumerera på standarder med tjänst SIS Abonnemang. 2017-07-01 2016-07-05 Standard Number. BS EN 62366-1:2015+A1:2020.
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EN 62366-1:2015. Superseded View Superseded By. Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard. Add to Watchlist What is StandardsWatch? This Standard has been added successfully to your Watchlist. Please visit My

evs-en 62366:2008 Medical devices – Application of usability engineering to medical devices General information 1983: N . Measurement of electroacoustical characteristics : IEC 60118-0 AMD 1 . 1994-01: N . Hearing aids; part_0: measurement of electroacoustical evs-en 62366-1:2015/ac:2018 Medical devices - Part 1: Application of usability engineering to medical devices Valid from 01.08.2018 UNE EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in June of 2015.), Category: On the other hand, as far as I understand, an EN standard that is adopted on EC national level (e.g. BS, DIN etc.) has to be identical in contents to the parent EN version. The reason is that compliance with the MDD (which may be served by compliance with harmonized standards) is legally achieved on EC national level.