ANSI AAMI IEC 62366-1-2015 pdf free download – Medical devices – Part 1: Application of usability engineering to medical devices.
USABILITY ENGINEERING activities for a MEDICAL DEVICE shall be planned，carried out， anddocumented by personnel competent on the basis of appropriate education, training, skills orexperience.
Where a documented product realization PROCEss exists, such as that described in Clause 7of lSO 13485:2003 [11], it shall incorporate the appropriate parts of or reference the uSABLITYENGINEERING PROCEss.
NOTE 1 Subclause 6.2 of lSO 13485:2003 contains additional information relating to personnel competence.A depiction of the interrelationship between the RISK MANAGEMENT PROCESs of ISO 14971:2007and the uSABILITY ENGINEERING PROocEss described in this standard is shown in Figure A.4.
The activities described in Clause 5, as shown Figure A.4, are described in a logical order,but they may be carried out in a flexible order as appropriate.
Consider compliance with this subclause to exist when the requirements of this lnternationalStandard have been fulfilled.
4.1.2 * RIsK CONTROL as it relates to uSER INTERFACE design
To reduce use-related RISK,the MANUFACTURER shall use one or more of the following options,in the priority listed (as required by lsO 14971:2007,6.2):
a) inherent sAFETY by design;
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROcEss;c) information for SAFETY.
NOTE Information for SAFETY can also be required by product standards and other sources.Compliance is checked by inspection of the usABILITY ENGINEERING FILE.
4.1.3lnformation for SAFETY as it relates to uSABILITY
When, in accordance with the priorities of 4.1.2，information for SAFETY is used as a RISKCONTROL measure,the MANUFACTURER shall subject this information to the USABILITYENGINEERING PROCEss to determine that the information
– is perceivable by,
– is understandable to, and
-supports cORRECT usE of the MEDICAL DEVICE by
USERs of the intended uSER PROFILEs in the context of the intended usE ENVIRONMENT.
NOTE 1 The relationship between usER perception, cognition and action is shown in Figure A.1.
NOTE 2 Examples of information for sAFETY are found in lEC 62366-2.
Conscious disregard of such information for SAFETY by the usER is considered to be anintentional 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 theMANUFACTURER(i.e.ABNORMAL USE).
Compliance is checked by inspection of the information for SAFETY and the uSABILITYENGINEERING FILE.
4.2* USABILITY ENGINEERING FILE
The results of the uSABILITY ENGINEERING PROCESs shall be stored in the USABILITYENGINEERING FILE.The RECORDs and other documents that form the uSABILITYENGINEERING FILEmay form part of other documents and files.
EXAMPLE 1 MANUFACTURER’s product design file.EXAMPLE 2 RISK MANAGEMENT FILE.
Compliance is checked by inspection of the uSABILITY ENGINEERING FILE.
4.3Tailoring of the uSABILITY ENGINEERING effort
The level of effort and the choice of methods and tools used to perform the uSABILITYENGINEERING PROCEss may vary based on:
a) the size and cOMPLEXITY of the uSER INTERFACE;
b) the sEVERITY of the HARM associated with the use of the MEDICAL DEVICE;
c) the extent or complexity of the usE SPECIFICATION;
d) the presence of uSER INTERFACE OF UNKNOWN PROVENANCE; and
e) the extent of the modification to an existing MEDICAL DEVICE USER INTERFACE that had been subjected to the uSABILITY ENGINEERING PROCEss.
Compliance is checked by inspection of the usABILITY ENGINEERING FILE.
5 * USABILITY ENGINEERING PROCEss
5.1 *Prepare usE SPECIFICATION
The MANUFACTURER shall prepare a usE SPECIFICATION.ANSI AAMI IEC 62366-1 pdf download.