IEC 62366-1:2015 pdf download.Medical devices - Part 1: Application of usability engineering to medical devices
1 Scope
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 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, 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,which 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-PRODUCTION survillance.
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 1 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
3.2 ACCOMP ANYING DOCUMENTATION
materials accompanying a MEDICAL DEVICE and containing information for the USER or those accountable for the installation, use and maintenance of the MEDICAL DEVICE， particularly regarding safe use
Note 1 to entry: The ACCOMPANYING DOCUMENTATION can consist of the instructions for use, technical description,installation manual, quick reference guide, etc.
Note 2 to entry: ACCOMPANYING DOCUMENTATION is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types.
Note 3 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction.[SOURCE: ISO 14971:2007，2.1， modified - The term has been changed to refer to 'documentation' rather than 'document', and in the definition 'document' has been replaced by 'material', 'OPERATOR' has been deleted and notes to entry have been added.]
3.3 CORRECT USE NORMAL USE without USE ERROR，
Note 1 to entry:Deviation from instructions for use is only considered USE ERROR if it leads to a MEDICAL DEVICE response that is different than intended by the MANUFACTURER or expected by the USER.
Note 2 to entry: Figure 1 shows the relationships of the types of use.IEC 62366-1 pdf download.