Home>BS standards>BS EN 62366-1:2015 pdf free

BS EN 62366-1:2015 pdf free

BS EN 62366-1:2015 pdf free.Medical devices – Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015).
This part of IEC 62366 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. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.
NOTE I SAFETY is freedom from unacceptable RISK. Unacceptable RISK can aris• from USE which can lead to 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 IEC 62366.22. wFHch addresses not only SAFETY but also aspects of USAbILITY not related to SAFETY.
If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY Is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PR0OuCTIO4 surveillance
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE I The way in which these referenced documents are cited in normative requirements determines the extent
(in whol. or in part) to which th.y apply.
NOTE 2 Informativo references are listed bn the bibliography beginning on page 46
ISO 14971:2007, Medical devices — Application of rEsk management to medical devices
3 Terms and definitions
For the purpose of this document, the terms and definitions given in ISO 14971:2007 and the following apply.
NOTE An index of defined terms is found beginning on page 49
conscious, intentional act or intentional omission of an act that is counter to or violates NORMAL USE and Is also beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the MANUFACTURER.BS EN 62366-1 pdf download.

Related PowerPoint Templates

Template Categories