Every information-for-safety element used as a risk control must be evaluated through the usability engineering process to confirm it is perceivable, understandable, and supports correct use — unchanged from 2015.
AMD1:2020 made no substantive change to this clause; editorial updates to cross-references only. Training at clause 4.1.2(c) now explicitly named as information for safety when used as a risk control.
Evidence in the usability engineering file that information-for-safety elements were evaluated for perceivability and comprehension — an IFU warning without usability test evidence is routinely flagged.
Maps to
IEC 62366: §4.1.3 Information for SAFETY as it relates to USABILITY
ISO 13485: §7.3.3 Design and development inputs
Requirement text
When, in accordance with the priorities of clause 4.1.2, information for safety is used as a risk control measure, the manufacturer shall subject this information to the usability engineering process to determine that the information is perceivable by, understandable to, and supports correct use of the medical device by users of the intended user profiles in the context of the intended use environment. Conscious disregard of information for safety by the user is considered a deliberate act or deliberate omission of an act that is counter to or violates normal use, and is beyond any further reasonable means of user interface-related risk control by the manufacturer (i.e., abnormal use). Compliance is checked by inspection of the information for safety and the usability engineering file.
Why this clause exists
Clause 4.1.3 exists because a warning or safety instruction placed in a device label or instructions for use is not inherently safe — it is safe only if the intended users can actually perceive it under real use conditions, understand its meaning accurately, and translate that understanding into the correct action. FDA MAUDE data documents repeated use errors attributable to warnings that users in time-critical environments did not see, could not read due to contrast or font size issues, or misinterpreted due to ambiguous terminology. The history of defibrillator alarm and infusion pump labeling incidents shows that manufacturers frequently designed information for safety elements based on engineering intent — the information was technically present — without ever systematically testing whether the intended users, in the intended environment (bright light, time pressure, personal protective equipment, auditory distraction), could actually perceive, process, and act on the information correctly. IEC 62366-1 clause 4.1.3 closes this gap by requiring that every information-for-safety element used as a risk control must be evaluated through the usability engineering process — not merely designed and printed.
What changed
Clause 4.1.3 was present in IEC 62366-1:2015 and AMD1:2020 made no substantive change to its normative requirements. The 2020 amendment updated cross-references throughout the standard (ISO 14971:2007 → ISO 14971:2019; ISO 13485:2003 → ISO 13485:2016) and applied defined-term capitalization conventions consistently, but the three-part obligation — perceivable, understandable, supports correct use — is unchanged. The connection to AMD1:2020’s explicit addition of training at clause 4.1.2(c) is indirect: when training is used as a risk control, the training materials constitute information for safety and are subject to the clause 4.1.3 evaluation.
Common gaps (what we see in audits)
- Information for safety accepted as a risk control without usability evaluation — Manufacturers identify a use-error hazard, add a warning to the IFU or a label to the device, and close the risk control in the Risk Table without ever evaluating whether the intended users can perceive and understand the warning under realistic conditions. This is the most direct violation of clause 4.1.3 and is a frequent finding in FDA human factors deficiency letters.
- Abnormal use classification used to escape risk control obligation for imperceptible warnings — Manufacturers sometimes classify user disregard of a warning as abnormal use without evidence that the disregard was conscious and deliberate. If the warning was not perceivable or understandable under the intended use conditions, the disregard is a use error — and the information for safety failed the clause 4.1.3 evaluation — not abnormal use.