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IEC 62366:2007 -- Medical devices - Application of usability engineering to medical devices
Item: Final
Document Type: International Standard
Abstract: This standard defines a usability-engineering process that ensures the basic safety and essential performance of medical devices related to usability. This standard is applicable to medical devices and combinations of medical devices. This standard addresses a process for reducing the likelihood use error. Abnormal use is outside of the scope of this standard.

Format: Print or Electronic
Number of Pages: 209
Publication Date: 01-Oct-2007
Order Notes: Order code is for U.S. version
Availability: Actual
Print Order Code: 62366    Price (Mbr/List): $65/$130
PDF Order Code: 62366-PDF    Price (Mbr/List): $65/$130
Category: Electromedical equipment
Subcategory: Maintenance, design and electrical safety
Activity: STANDARDS
Keywords: human factors engineering, ergonomics, human factors

Staff Contact: jmoyer@aami.org
Project Type: New document
Project Status: Completed
Document Status: Current
Ballot Committee: IEC/SC 62A, Common Aspects of Electrical Equipment Used in Medical Practice
Committee Author: IEC/SC 62A/MT 25, Ergonomics and graphical symbols
Tag: AAMI/HE, Human Factors Engineering Committee
FDA Recognition Info: FDA-recognized
Extent Of Recognition: See FDA Detail Sheet
Link to FDA List: Choose Category "General"

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