The standard also applies to documentation that may accompany a device, and to the training of intended users. To verify the current status of this type of information, we recommend. Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. This technical report is intended to be read in conjunction with iec 623661. Application of usability engineering to medical devices edition 1. Iec 62304 medical device software development life cycle. Guidance on the application of usability engineering to medical devices to be more usable. Get a quote for certification of systems, products or services, and get certified. Iec 623661 and usability engineering for software software. To verify the current status of this type of information, we recommend contacting the member body mb or national certification body ncb of the relevant country. However, it does not apply to clinical decisionmaking. Purchase your copy of 1830359002 dc as a pdf download or hard copy directly from the official bsi shop.
Specifies a process for a manufacturer to analyze, specify, develop and evaluate the. In the future, iec 62366 will completely replace iec 6060116. This usability engineering human factors engineering process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i. Guidance on the application of usability engineering to medical devices to be more usable, easier to understand than original 62366 contains the what requirements in part 1, the how is in 623662. Iec 62366 is a processbased standard that aims to help manufacturers of medical devices to design for high usability. All bsi british standards available online in electronic and print formats. Application of usability engineering to medical devices pdf. Iec tc 62, electrical equipment in medical practice and isotc 210, quality management and. The iec 62366 standard calls out the errors caused by inadequate medical device usability have become an increasing cause for concern.
Download standards through your account documents are normally available within a few minutes. The international electrotechnical commission iec is the leading global organization that prepares and publishes international standards for all electrical, electronic and related technologies. The report is guidance on a general usability engineering process meant to help make medical devices safer when being used by both professionals and by lay persons. The aligned elements iec 62366 configuration is a significantly large extension to apply. Iec 623661 and iec 623662 release thay medical human. To get the proper understanding of the extension aspects, we strongly recommend that you book a live demonstration of the aligned elements iec 62366 configuration, please this email address is being protected from spambots. May 06, 2016 along with the iec 62366 1, this new technical report replaces the now obsolete iec 62366 from 2007 and the amendment 1 from 2014. 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. Application of usability engineering to medical devices.
Application of usability engineering to medical devices, includes corrigendum 1. Application of usability engineering to medical devices soon iectr 62366 2. The common sense systems iec 62304 checklist is a convenient and easytouse tool for medical device software engineering personnel who are involved in a software project for a class a, b or c. Isoiec 62366 is a processbased standard that aims to help manufacturers of medical devices design in usability and design out use errors. Iec 6060116, the usability collateral standard for medical electrical equipment, was the base for iec 62366. The ieciecee is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. The iec iecee is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. The intended reader for this technical report includes the people or organisations that are involved with planning, funding. The numbers of older iec standards were converted in 1997 by adding 60000. Iec 60027 letter symbols to be used in electrical technology iec 60028 international standard of resistance for copper iec 60034 rotating electrical machinery iec 60038 iec. To get the proper understanding of the extension aspects, we strongly recommend that you book a live. Although usability engineering is a requirement for the design of medical devices, most of people designing software are not familiar with this process. The changes to from iec iso 62366 to iec 62366 1 and the additional iec 62366 2 are positive, and will hopefully result in developers understanding the intended use of the medical device in a slight bit more detail, and in a way, industry is currently understanding usability and the human factors related to medical devices.
Iec 62366 is a processbased standard that aims to help. Specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This first edition of iec 623661, together with the first edition of iec 623662, cancels and replaces the first edition of iec 62366 published in 2007 and its amendment 1 2014. The publication of the internationally harmonized usability standards iec 623661. The new iec 62366 1 describes a contemporary usability engineering process that is somewhat streamlined compared to the previously prescribed one. The publication of the internationally harmonized usability standards iec 62366 1. The intended reader for this technical report includes the people or organisations that are involved with planning, funding, managing, and performing research, design, evaluation and regulatoryrelated activities i. If you have not connected to the audio portion of the.
Medizinprodukte, usabilityengineeringprozess, din en 62366. Iec 62304 compliance checklist common sense systems. The changes to from ieciso 62366 to iec 623661 and the additional iec 623662 are positive, and will hopefully result in developers understanding the intended use of the medical device in a slight bit more. Or download the pdf of the directive or of the official journal for free. It does not apply to clinical decisionmaking that may be related to the use of the device. Usability engineering to iec 62366 1 thay medical ltd. The iec 62366 formulates requirements for the main operating functions of medical devices. This technical report is intended to be read in conjunction with iec 62366 1. Jul 06, 2018 it is supported by the publication aami he75 standard, fda guidances, and the publication of iec 62366 in 2008 followed by iec 62366 1. Unfortunately, they do not define the term function and causes confusion.
Human factors and usability engineering guidance for medical. The international standard iec 62366 medical devices application of usability engineering to. Application of usability engineering to medical devices iec tr 623662. The standard on usability and human factors engineering, iec 62366 1, is referenced in a note at the bottom of this clause. This process works in a similar manner to other parts of device design specification, research, development, testing, iteration and in iso 14971. Din en 62366 200809 medical devices application of usability engineering to medical devices iec 62366.