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.
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.
Atomic constraints
- •A documented use specification must exist before hazard-related use scenarios are identified.
- •The USE SPECIFICATION must describe the intended USER PROFILE (§3.29) — the mental, physical, and demographic traits of each user group, plus relevant knowledge, skills, abilities, and limitations.
- •The intended use environment (physical setting, cognitive demands, distractions, social context) must be described.
- •User interface characteristics relevant to safety (e.g., alarm conditions, critical displays) must be specified.
- •The use specification must serve as a traceable input to the hazard-related use scenario analysis.
Common gaps
User profiles defined too broadly
majorFDA 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.
Evidence signals
- •
FILE_EXISTS
Intended.*Use|Use.*Specification|Device.*Description|User.*Profile
- •
CONTENT_MATCH
Does this document describe intended user profiles (skills, experience, training), the intended use environment (physical setting, workflow context, distractions), and user interface characteristics relevant to safe device use?
Audit defense
The Use Specification for [your product] (Doc ID: [your document ID]) describes intended user profiles, the clinical use environment, and safety-relevant UI characteristics. This specification served as the input to our Hazard-Related Use Scenario analysis and drove UI design decisions during development.