IEC 60601-1-6
E477171
IEC 60601-1-6 is a collateral standard in the IEC 60601 series that specifies usability engineering requirements for medical electrical equipment and systems to help ensure safety and effectiveness in clinical use.
Statements (44)
| Predicate | Object |
|---|---|
| instanceOf |
IEC standard
ⓘ
medical device usability standard ⓘ |
| aimsTo |
reduce risks associated with use of medical electrical equipment
ⓘ
reduce risks associated with use of medical electrical systems ⓘ |
| appliesTo |
medical electrical equipment
ⓘ
medical electrical systems ⓘ |
| focusesOn |
usability of medical electrical equipment
ⓘ
usability of medical electrical systems ⓘ |
| hasAbbreviation | IEC NERFINISHED ⓘ |
| hasDomain |
clinical engineering
ⓘ
healthcare usability ⓘ medical technology ⓘ |
| hasGoal |
improvement of clinical effectiveness
ⓘ
improvement of patient safety ⓘ improvement of user interface design ⓘ reduction of use errors ⓘ |
| hasPurpose |
to help ensure effectiveness in clinical use
ⓘ
to help ensure safety in clinical use ⓘ |
| hasScope |
requirements for documentation of usability engineering
ⓘ
requirements for evaluation of usability ⓘ requirements for usability engineering process ⓘ |
| hasSubject | usability engineering ⓘ |
| hasType | collateral standard ⓘ |
| isCollateralTo | IEC 60601-1 NERFINISHED ⓘ |
| isReferencedIn | medical device regulatory guidance in multiple jurisdictions ⓘ |
| isRelatedStandard | IEC 62366 NERFINISHED ⓘ |
| isUsedBy |
medical device manufacturers
ⓘ
regulatory affairs professionals ⓘ usability engineers ⓘ |
| isUsedFor |
design of medical electrical equipment
ⓘ
development of medical electrical systems ⓘ validation of usability of medical devices ⓘ verification of usability engineering processes ⓘ |
| partOf | IEC 60601 series NERFINISHED ⓘ |
| publishedBy | International Electrotechnical Commission NERFINISHED ⓘ |
| relatesTo |
human factors engineering
ⓘ
risk management for medical devices ⓘ user interface design ⓘ |
| requires |
systematic usability engineering process
ⓘ
usability engineering file ⓘ |
| supports |
demonstration of basic safety related to usability
ⓘ
demonstration of essential performance related to usability ⓘ |
| targets |
intended use environments of medical electrical equipment
ⓘ
intended users of medical electrical equipment ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.