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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| IEC 60601-1-10 canonical | 3 |
How this entity was disambiguated
This entity first appeared as the object of triple T4780754 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: IEC 60601-1-10 Context triple: [IEC 60601-1, isBasisFor, IEC 60601-1-10]
-
A.
IEC 60601-1-6
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.
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B.
IEC 60601-1
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
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C.
IEC 60601-1-8
IEC 60601-1-8 is a collateral standard within the IEC 60601 series that specifies requirements for alarm systems in medical electrical equipment and systems to ensure safe and effective clinical use.
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D.
IEC 60601-1-9
IEC 60601-1-9 is a collateral standard within the IEC 60601 medical electrical equipment series that specifies requirements for environmentally conscious design of medical devices.
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E.
IEC 62368
IEC 62368 is a safety standard for audio/video, information, and communication technology equipment that uses a hazard-based approach to risk assessment and protection.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: IEC 60601-1-10 Target entity description: 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.
-
A.
IEC 60601-1-6
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.
-
B.
IEC 60601-1
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
-
C.
IEC 60601-1-8
IEC 60601-1-8 is a collateral standard within the IEC 60601 series that specifies requirements for alarm systems in medical electrical equipment and systems to ensure safe and effective clinical use.
-
D.
IEC 60601-1-9
IEC 60601-1-9 is a collateral standard within the IEC 60601 medical electrical equipment series that specifies requirements for environmentally conscious design of medical devices.
-
E.
IEC 62368
IEC 62368 is a safety standard for audio/video, information, and communication technology equipment that uses a hazard-based approach to risk assessment and protection.
- F. None of above. chosen
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 ⓘ |
| 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
ⓘ
linked to:
IEC 60601
|
| publishedBy | International Electrotechnical Commission ⓘ |
| relatedTo |
IEC 60601-1-6
ⓘ
IEC 60601-1-8 ⓘ IEC 62304 ⓘ |
| 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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: IEC 60601-1-10 Description of subject: 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.
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.