IEC 62366-1:2015 MEDICAL DEVICES -Part 1: Application of usability engineering to medical devices

IEC 62366-1:2015.MEDICAL DEVICES -Part 1: Application of usability engineering to medical devices. 1 * Scope This part of lEC 62366 specifies a PRocEss for a MANUFACTURER to analyse,specify,developand evaluate the usABLITY of a MEDICAL. DEVICE as it relates to SAFETY. This uSABILITYENGINEERING (HUMAN FACTORS ENGINEERING) PROCEss permits the MANUFACTURER to assessand mitigate RIsKs associated with coRRECT uSE and uSE ERRORs, i.e.,NORMAL USE. lt can beused to identify but does not assess or mitigate RISKs associated with ABNORMAL USE. NOTE 1 SAFETY is freedom from unacceptable RISK.Unacceptable RISK can arise from usEERROR, which can leadto exposure to direct physical HAzARDs or loss or degradation of clinical functionality. NOTE 2 Guidance on the application of uSABILITY ENGINEERING to MEDICAL DEVICES is available in lEC 62366-2,which addresses not only SAFETY but also aspects of uSABILITY not related to SAFETY. lf the uSABLLITY ENGINEERING PROCEss detailed in this International Standard has beencomplied with, then the usABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to beacceptable, unless there is oBJECTIVE EVIDENCE to the contrary. NOTE 3 Such oBJECTIVEEVIDENCE can subsequently originate from PoST-PRODUcTION surveillance.2Normative references The following documents, in whole or in part, are normatively referenced in this document andare indispensable for its application.For dated references, only the edition cited applies.Forundated references,the latest edition of the referenced document (including anyamendments) applies. NOTE1 The way in which these referenced documents are cited in normative requirements determines the extent(in whole or in part) to which they apply. NOTE 2 Informative references are listed in the bibliography beginning on page 46. ISO 14971:2007,Medical devices - Application of risk management to medical devices 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 14971:2007 and thefollowing apply. NOTE An index of defined terms is found beginning on page 49.