IEC 60601-1-11
E483948
IEC 60601-1-11 is a collateral standard specifying additional requirements for the safety and performance of medical electrical equipment and systems used in the home healthcare environment.
All labels observed (1)
| Label | Occurrences |
|---|---|
| IEC 60601-1-11 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T4780755 — 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 60601-1-11 Context triple: [IEC 60601-1, isBasisFor, IEC 60601-1-11]
-
A.
IEC 60601-1-10
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.
-
B.
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.
-
C.
IEC 60601-1
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
-
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 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.
- 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 60601-1-11 Target entity description: IEC 60601-1-11 is a collateral standard specifying additional requirements for the safety and performance of medical electrical equipment and systems used in the home healthcare environment.
-
A.
IEC 60601-1-10
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.
-
B.
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.
-
C.
IEC 60601-1
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
-
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 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.
- F. None of above. chosen
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
IEC standard
ⓘ
medical device safety standard ⓘ |
| addresses |
cleaning and disinfection in home environments
ⓘ
electrical hazards in home healthcare use ⓘ environmental conditions in home healthcare ⓘ instructions for use for lay operators ⓘ marking and labeling for home use equipment ⓘ mechanical hazards in home healthcare use ⓘ protective earth and protective means in home use ⓘ reliability of power supply in home healthcare ⓘ transport and storage conditions for home healthcare equipment ⓘ transport of medical electrical equipment for home use ⓘ |
| appliesTo |
home healthcare environment
ⓘ
medical electrical equipment ⓘ medical electrical systems ⓘ |
| belongsToCategory | medical device regulation and standards ⓘ |
| defines | home healthcare environment ⓘ |
| focusesOn | use of medical electrical equipment in home healthcare ⓘ |
| hasAbbreviation | IEC 60601-1-11 NERFINISHED ⓘ |
| hasApplicationArea |
home dialysis equipment
ⓘ
home infusion pumps ⓘ home monitoring equipment ⓘ home ventilators ⓘ |
| hasEdition | 2nd edition ⓘ |
| hasScope | medical electrical equipment and systems intended for use in the home healthcare environment ⓘ |
| hasTitle | Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment NERFINISHED ⓘ |
| intendedForUseBy |
manufacturers of medical electrical equipment
ⓘ
regulatory authorities ⓘ test laboratories ⓘ |
| isCollateralStandardTo | IEC 60601-1 NERFINISHED ⓘ |
| language |
English
ⓘ
French ⓘ |
| partOf | IEC 60601 series NERFINISHED ⓘ |
| publishedBy | International Electrotechnical Commission NERFINISHED ⓘ |
| relatedTo |
IEC 60601-1-10
NERFINISHED
ⓘ
IEC 60601-1-12 NERFINISHED ⓘ |
| requires |
adequate usability for home users
ⓘ
consideration of lay operator capabilities ⓘ consideration of reasonably foreseeable misuse in home healthcare ⓘ risk management considering home use conditions ⓘ |
| revises | IEC 60601-1-11:2010 NERFINISHED ⓘ |
| specifies |
additional requirements for basic safety
ⓘ
additional requirements for essential performance ⓘ |
| supplements | IEC 60601-1 basic safety and essential performance requirements ⓘ |
| supports | regulatory compliance for home-use medical electrical equipment ⓘ |
| usedIn | conformity assessment of home-use medical devices ⓘ |
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 60601-1-11 Description of subject: IEC 60601-1-11 is a collateral standard specifying additional requirements for the safety and performance of medical electrical equipment and systems used in the home healthcare environment.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.