ANSI AAMI IEC 62366-1 pdf free download

ANSI AAMI IEC 62366-1 pdf free download.Medical devices – Part 1: Application of usability engineering to medical devices.
3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 1 4971 :2007 and the following apply. NOTE An index of defined terms is found beginning on page 39. 3.1 * ABNORMAL USE 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 EXAMPLES Reckless use or sabotage or intentional disregard of information for SAFETY are such acts. Note 1 to entry See also 4.1 .3. Note 2 to entry: An intended but erroneous action that is not ABNORMAL USE is considered a type of USE ERROR.Note 3 to entry: A BNORMAL USE does not relieve the MANUFACTURER from considering non- USER INTERFACE -related means of RISK CONTROL Note 4 to entry: Figure 1 shows the relationships of the types of use.3.2 ACCOMPANYING 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: A CCOMPANYING 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: M EDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction. [SOURCE: ISO 1 4971 :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– The term has been changed to refer to ‘documentation’ rather than ‘document’, and in the definition ‘document’ has been replaced by ‘material’, ‘ OPERATOR ’ has been deleted and notes to entry have been added.] 3.3 CORRECT USE NORMAL USE without USE ERROR Note 1 to entry: Deviation from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. 3.4 EFFECTIVENESS accuracy and completeness with which USERS achieve specified goals Note 1 to entry: This is a different concept than ‘clinical effectiveness’. [SOURCE: ISO 9241 -1 1 :1 998, 3.2, modified – Added the note to entry.]3.6 EXPECTED SERVICE LIFE time period specified by the MANUFACTURER during which the MEDICAL DEVICE is expected to remain safe for use (i.e. maintain basic SAFETY and essential performance) Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE . [SOURCE: IEC 60601 -1 :2005 and IEC 60601 -1 :2005/AMD1 :201 2, 3.28, modified – In the definition, ‘ ME EQUIPMENT and ME SYSTEM ’ have been replaced with ‘ MEDICAL DEVICE ’.] 3.7 FORMATIVE EVALUATION USER INTERFACE EVALUATION conducted with the intent to explore USER INTERFACE design strengths, weaknesses, and unanticipated USE ERRORS Note 1 to entry: F ORMATIVE EVALUATION is generally performed iteratively throughout the design and development PROCESS , but prior to SUMMATIVE EVALUATION , to guide USER INTERFACE design as necessary. 3.8 HAZARD – RELATED USE SCENARIO USE SCENARIO that could lead to a HAZARDOUS SITUATION or HARM Note 1 to entry: A HAZARD – RELATED USE SCENARIO can often be linked to a potential USE ERROR . Note 2 to entry: A HAZARD – RELATED USE SCENARIO is not related to a failure of the MEDICAL DEVICE , unless the MEDICAL DEVICE failure was caused by a USE ERROR.ANSI AAMI IEC 62366-1 pdf download.