IEC 62366-1-2015 pdf free download Medical devices – Part 1: Application of usability engineering to medical devices

07-22-2021 comment

IEC 62366-1-2015 pdf free download.Medical devices – Part 1: Application of usability engineering to medical devices.
4 Principles
4.1 General requirements
4.1.1 USABILITY ENGINEERING PROCESS
The MANUFACTURER shall establish, document, implement and maintain a USABILITY ENGINEERING PROCESS, as defined in Clause 5, to provide SAFETY for the PATIENT, USER and others. The PROCESS shall address USER interactions with the MEDICAL DEVICE according to the ACCOMPANYING DOCUMENTATION, including, but not limited to:
— transport:
— storage:
— installation;
— operation;
— maintenance and repair: and
— disposal.
UsAsILrrv ENGINEERING activities for a MEDICAL DEVICE shall be planned, carried out, and documented by personnel competent on the basis of appropriate education, training, skills or experience.
Where a documented product realization PROCESS exists, such as that described in Clause 7 of ISO 13485:2003 1111, it shall incorporate the appropriate parts of or reference the USABILITY
ENGINEERING PROCESS.
NOTE I Subclause 6.2 of ISO 13485:2003 contains additional information relating to personnel competence A depiction of the interrelationship between the RISK MANAGEMENT PROCESS of ISO 14971:2007 and the USABILITY ENGINEERING PROCESS 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 International Standard 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 ISO 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.
4.1.3 Information for SAFETY as It relates to USABILITY
When, in accordance with the priorities of 4.1.2, information for SAFETY is used as a RISK CONTROL measure, the MANUFACTURER shall subject this information to the USABILITY ENGINEERING PROCESS to determine that the information is also beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the MANUFACTURER (I.e. A8NORMAL USE).
Compliance is checked by inspection of the information for SAFETY and the USABILITY ENGINEERING FILE.
4.2 USABILITY ENGINEERING FILE
The results of the USABILITY ENGINEERING PROCESS shall be stored in the USABILITY ENGINEERING FILE. The RECORDS and other documents that form the USABILITY ENGINEERING FILE may form part of other documents and Ales.
EXAMPLE I MANUFACTURERS product design tile.
EXAMPLE 2 Risc I.IANAGEUENT FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
4.3 TailorIng of the USABILITY ENGINEERING effort
The level of effort and the choice of methods and tools used to perform the USABILITY ENGINEERING PROCESS may vary based on:
a) the size and CGMPLEXITY 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.IEC 62366-1 pdf download.

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