IEC TR 62366-2-2016 pdf download.Medical devices – Part 2: Guidance on the application of usability engineering to medical devices.
The intended reader for this technical report includes the people or organisations that are involved with planning, funding, managing. and performing research, design, evaluation and regulatory-related activities (i.e. approbation) related to MEDICAL DEVICES, including, but not limited to:
• company, department, project, and product managers;
• design and engineering professionals (e.g. human factors engineers, industrial designers. technical writers, information designers, software developers, mechanical engineers. electrical engineers, packaging engineers):
• medical researchers and other interested clinicians;
• marketers and other business professionals in the MEDICAL DEVICE industry;
• quality or regulatory staffs of MEDICAL DEVICE MANUFACTURERS (for example, regulatory affairs, RISK MANAGEMENT or quality management roles); and
• writers of product standards.
This technical report Is neither Intended as the sole source of USABILITY ENGINEERING guidance for MEDICAL DEVICE MANUFACTURERS, nor a complete substitute for human factors expertise. Rather, it is intended to provide readers with a general understanding of how to perform USABILITY ENGINEERING ifl an economic manner. Readers are advised to supplement the knowledge they gain from this report with knowledge acquired from complementary documents including those specific to the MEDICAL DEVICE of interest. A list of useful USABILITY ENGINEERING resources and further readings is provided in Annex A.
This report does not address detailed USABILITY ENGINEERING design guidance or requirements, such as recommendations on the proper size of text on a computer screen, appropriate ways to arrange a workstation’s displays and controls, or characteristics of an appropriate ALARM SIGNAL. Such information can be found in other documents, such as (1J(21[311411.
This technical report does not describe a specific set of USABILITY ENGINEERING activities that suit all design projects. Instead, it gives guidance for a general USABILITY ENGINEERING PROCESS requiring further shaping and tailoring to suit a given development project’s needs. USABILITY ENGINEERING practice varies widely throughout the world and even within specific countries, companies, and company units. This variation is partly due to the diversity found among USABILITY ENGINEERING practitioners who can have a background in one or more of various professional fields, such as engineering, psychology, or design. Practice differences also exist due to the wide variety of MEDICAL. DEVICES, which range from seemingly simple syringes to complex imaging systems. some of which are used in hospitals, clinics, andlor the home by various types of medical professionals as well as laypersons (e.g. PATIENTS and caregivers who take care of PATIENTS, such as a child or spouse).
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.IEC TR 62366-2 pdf download.