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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. Title. Medical devices. Application of usability engineering to medical devices.

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 publication of the internationally harmonized usability standards IEC 62366-1:20151 and IEC TR 62366-2:20162 replaces the prior edition of the usability standard, IEC 62366:2007+AMD1:20143. The new IEC 62366-1 describes a contemporary usability engineering process that is somewhat streamlined compared to the previously prescribed one. Status: Upphävd. · Ersätts av: SS-EN 62366-1 Tillägg: SS-EN 62366 A 1. Köp denna standard.

Guidance on the application of usability engineering to medical devices 19/30357102 DC BS EN 60601-1-6 AMD2. I.S. EN 62366-1:2015.

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EN 62366-1: Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Practical guides for determining conformity In a company, quality management representatives or quality and regulatory affairs managers usually come into contact with the proof of compliance of the products in terms of the general safety and 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. 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.

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1 Standarder avser främst standardserien IEC 60601-1 samt angivna nationella avvikelser (t.ex.

European Harmonized vs IEC standard. EN 62366:2008 • A User centred design process = Usability Engineering Process • Also applies to accompanying documents and user training • Performs Risk Management – ISO 14971 • Results of Usability Engineering Process shall be recorded in the Usability Engineering File • Usability Engineering Process has 9 stages 22 EN 62366-1:2015 Application of usability engineering to medical devices EN 62366:2007 och A1:2015/new standard 31/mar/18 EN 60601-2-60:2015 Particular requirements for the basic safety and essential performance of dental equipment New standard 14/apr/18 EN 60601-2-62:2015 Particular requirements for the basic safety and essential performance of high BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices PD IEC/TR 62366-2:2016 Medical devices.
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Application of usability engineering to medical devices. Status. Current.

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. Usability and ergonomics have become important quality and performance features of medical devices.
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IEC 60601-1:2005/A1:2012 Medical devices - Part 1: Application of usability engineering to medical devices Close. DS/EN 62366-1:2015 BS EN 62366-1:2015+A1:2020 Medical devices Application of usability engineering to medical devices, Category: 11.040 Medical equipment EN 62366:2008 • A User centred design process = Usability Engineering Process • Also applies to accompanying documents and user training • Performs Risk Management – ISO 14971 • Results of Usability Engineering Process shall be recorded in the Usability Engineering File • Usability Engineering Process has 9 stages 22 BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices (British Standard) Available for Subscriptions.