Maps to
QMSR / ISO 13485: §820.30(c)
ISO 13485: §7.3.3
IEC 62366: §5.1
Requirement text
The manufacturer shall prepare a use specification describing the intended users (knowledge, skills, experience), the intended use environment (physical, social, technical context), and the user interface characteristics relevant to safety. 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. A concept of User Interface of Unknown Provenance (UOUP) was added, allowing simplified evaluation for legacy or off-the-shelf interfaces based on post-market data.
Amendment 1 (2020) further refined the standard: it updated the ISO 14971 reference to the 2019 edition, introduced bidirectional exchange between risk management and usability engineering (previously one-directional), added training as a third priority risk control measure alongside information for safety, introduced the concept of 'use difficulty' (close calls and observed problems that don't result in actual use errors), and replaced 'action error' with 'physical mismatch' to encourage broader analysis of use problems.
Atomic constraints
- •A documented use specification must exist before hazard-related use scenarios are identified.
- •The use specification must describe intended user populations including knowledge, skills, and relevant 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.