Work Item
ASTM WK77855

New Guide for Development and Execution of Usability Evaluations in Medical Packaging

1. Scope

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 ASTM Committee.


Developed by Subcommittee: F02.50

Committee: F02

Staff Manager: W Scott Orthey

Work Item Status

Date Initiated: 07-30-2021

Technical Contact: Chris Sarantos

Item: 000