IEC 60601-1-10
E482138
IEC 60601-1-10 is a collateral standard within the IEC 60601 series that specifies requirements for the development of physiologic closed-loop controllers used in medical electrical equipment and systems.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
IEC standard
ⓘ
collateral standard ⓘ medical device safety standard ⓘ |
| addresses |
alarm conditions related to closed-loop control
ⓘ
control performance limits for physiologic closed-loop controllers ⓘ data logging for closed-loop control behavior ⓘ design of control algorithms for physiologic closed-loop controllers ⓘ fault tolerance in physiologic closed-loop controllers ⓘ hazard analysis for closed-loop control ⓘ monitoring of patient variables in closed-loop systems ⓘ transition between automatic and manual control modes ⓘ user interface aspects of closed-loop controllers ⓘ validation of physiologic closed-loop controllers ⓘ verification of physiologic closed-loop controllers ⓘ |
| appliesTo |
hardware implementing physiologic closed-loop control
ⓘ
medical electrical equipment ⓘ medical electrical systems ⓘ software implementing physiologic closed-loop control ⓘ |
| definesRequirementsFor | development of physiologic closed-loop controllers ⓘ |
| field |
biomedical engineering
ⓘ
clinical engineering ⓘ medical technology ⓘ |
| focusesOn |
effectiveness of physiologic closed-loop controllers
ⓘ
risk management for closed-loop control ⓘ safety of physiologic closed-loop controllers ⓘ |
| isCollateralTo | IEC 60601-1 NERFINISHED ⓘ |
| language | English ⓘ |
| objective |
ensure predictable behavior of closed-loop systems
ⓘ
ensure safe interaction between controller and patient ⓘ reduce risks associated with automatic physiologic control ⓘ |
| partOf | IEC 60601 series NERFINISHED ⓘ |
| publishedBy | International Electrotechnical Commission NERFINISHED ⓘ |
| relatedTo |
IEC 60601-1-6
NERFINISHED
ⓘ
IEC 60601-1-8 NERFINISHED ⓘ IEC 62304 NERFINISHED ⓘ |
| requires |
consideration of actuator failures in closed-loop systems
ⓘ
consideration of patient variability in controller design ⓘ consideration of physiological models in controller design ⓘ consideration of sensor failures in closed-loop systems ⓘ consideration of software failures in closed-loop systems ⓘ |
| scopeIncludes |
controllers that automatically adjust therapy based on patient variables
ⓘ
controllers that operate without continuous operator intervention ⓘ |
| subject | physiologic closed-loop controllers ⓘ |
| typeOfCollateralStandard | safety-related collateral standard ⓘ |
| usedBy |
medical device manufacturers
ⓘ
regulatory bodies ⓘ test laboratories ⓘ |
Referenced by (1)
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