Documented intended use, user population, and use environment as design inputs — present in prior HFE practice, now structured as a required standalone specification.
Explicit Use Specification document with defined user profiles — mental, physical, and demographic traits — serving as traceable input to hazard-related use scenario analysis.
User profiles defined too broadly — 'healthcare practitioners' — are a common FDA deficiency; reviewers expect cognitive and physical characteristics, not marketing segments.
Maps to
IEC 62366: §5.1 Prepare USE SPECIFICATION
ISO 13485: §7.3.3 Design and development inputs
Pre-QMSR Part 820 (legacy QSR): §820.30(c) Design input.
Requirement text
The manufacturer shall prepare a USE SPECIFICATION that includes the intended medical indication, intended patient population, intended part of the body or type of tissue applied to or interacted with, intended USER PROFILE (per §3.29: the mental, physical, and demographic traits of a user group, plus knowledge, skills, and abilities relevant to design decisions), intended use environment, and operating principle (per §5.1). This specification forms the basis for hazard-related use scenario identification.
Why this clause exists
Hazard-related use scenarios cannot be reliably identified without a prior, explicit description of who is using the device, where, and under what cognitive conditions — because the same interface element creates different hazard profiles depending on the user group. A medication dosing input field is a minor legibility concern for a pharmacist in a quiet clinical workstation and a critical safety risk for a paramedic operating under time pressure in a moving vehicle. FDA's Refuse-to-Accept deficiency data for human factors submissions consistently flags user profiles defined at the level of 'healthcare practitioners' as insufficient — reviewers expect characteristics like visual acuity, motor dexterity under stress, training frequency, and fatigue profile, because those are the factors that determine whether a display format, an alarm sound level, or a button size will generate use errors. IEC 62366-1:2015 clause 5.1 formalizes the Use Specification as a required pre-condition to hazard analysis precisely because regulators observed that manufacturers who skipped or summarized user characterization ended up with hazard analyses that reflected engineering assumptions about users rather than actual user capabilities — and those assumptions were systematically optimistic.
What changed
IEC 62366-1:2015 replaced the 2007 first edition with a major restructuring. The standard was split into Part 1 (normative requirements) and Part 2 (IEC TR 62366-2, informative guidance and methods). The scope broadened to include hazards of all types including psychological hazards, not just direct physical hazards.
The standard introduced a formative/summative evaluation framework not present in 2007. The 2007 requirement to identify primary operating functions was removed — instead, the 2015 version mandates identification and evaluation of hazard-related use scenarios.
Amendment 1 (IEC 62366-1:2015+AMD1:2020 CSV) made no substantive normative change to this clause. Changes were editorial: the normative reference to ISO 14971:2007 was updated to ISO 14971:2019 throughout the standard, ISO 13485 reference updated to 2016 edition, and defined-term capitalization conventions were applied consistently.
Common gaps (what we see in audits)
- User profiles defined too broadly — FDA reviewers frequently flag 'Refuse-to-Accept' deficiencies when user profiles are too broad (e.g., 'healthcare practitioners' or 'doctors'). They expect physical and cognitive characteristics such as visual acuity, mental workload under emergency conditions, and experience levels. The 2020 amendment expanded environment characterization to include social factors.