For the context of medical device usability engineering rather than pharmaceuticals, I would direct you to ISO / EN ISO 20417:2021 such as, but not limited to, sub-clause 6.3 and Annex B (for devices with a built-in display of the IFU), and for all devices, sub-clauses 6.6.1(e) and 6.6.2(b & p), and for lay users 6.6.3(b, c, d, and maybe e), and also AAMI HF 75 [sections 11, 16, 19 (visual displays), and 24 (mobile device displays)], any and all done within the bounds and paradigms of IEC 62366.
I also think FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices (see 8.1.3 therein) is a useful beacon to help see how to apply the aforesaid standards and principles to instructions for use. FDA's guidance Do It By Design and also Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management may also help.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 28-Jan-2022 02:19
From: Cathy Mills
Subject: IFU Readability
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