This guide provides considerations for the assessment of usability for terminally sterilized medical packaging. Guidance is applicable to heuristic, formative, and summative assessments, and is intended to satisfy minimum requirements of AAMI/ANSI/ISO 11607-1, 7.1 Usability. Further, this document is also to provide supplemental guidance to enhance setup and execution of assessments for the improvement of aseptic presentation. Guidance defines considerations for the appropriate Users, Sampling, and a variety of different Use Environments.
Usability; Human Factors; Medical Packaging; User; Aseptic Handling; Operating Theater; Assessors; Moderators; Healthcare Professional; Aseptic Openings; Use
No guide exists to help meet the requirements of ISO 11607.
The title and scope are in draft form and are under development within this