What is IEC 62366 and who must apply it?
IEC 62366-1:2015 + AMD1:2020 · Scope (62366-2 = informative guidance)
The short answer
IEC 62366-1 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. The goal is to identify and mitigate risks from correct use and from use errors during normal use. The standard applies to all medical devices — electrical, software (SaMD) and IVD. Current: 62366-1:2015 + AMD1:2020. 62366-2 is informative guidance, not a standard you comply with.
What IEC 62366 governs
62366-1 is a process standard: it does not require a particular design, but a traceable approach for identifying and mitigating use-related risks. The output is the usability engineering file.
Who must apply IEC 62366
All medical device manufacturers — regardless of technology:
- Electrical devices (via 60601-1-6, which requires 62366-1)
- Software as a Medical Device (SaMD), including apps and web applications
- In-vitro diagnostics (IVD)
This is the key difference from 60601: while 60601 only concerns electrical hardware, usability engineering per 62366-1 applies to every device type.
Normal vs. abnormal use — an important boundary
62366-1 addresses use errors in normal use. Risks from abnormal use (deliberate misuse, gross off-label use) can be identified by the standard, but it does not require their mitigation to the same extent. State your scope precisely — overreaching leads to findings.
62366-1 vs. 62366-2 — do not confuse them
| Document | Status | What it is |
|---|---|---|
| IEC 62366-1:2015 + AMD1:2020 | Normative | The "shall" requirements — what you apply |
| IEC 62366-2 | Informative (guidance) | Tutorial on usability engineering and human factors methods — not a requirement |
Never say "compliant with 62366-2". 62366-2 is supporting guidance, not a standard you conform to.
Frequently asked questions
Does 62366 also apply to pure software?
Yes. Usability engineering is technology-independent — SaMD, apps and web applications fall under it just as electrical devices do.
Which edition is current?
IEC 62366-1:2015 + AMD1:2020. The older single-part IEC 62366:2007 was split and superseded — do not reference it as the current state.