IEC 60601-1
E106157
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
All labels observed (7)
| Label | Occurrences |
|---|---|
| ANSI/AAMI ES60601-1 | 1 |
| EN 60601-1 | 1 |
| IEC 60601 | 1 |
| IEC 60601-1 canonical | 1 |
| IEC 60601-1-2 | 1 |
| IEC 60601-2-xx collateral and particular standards | 1 |
| International Standard IEC 60601-1 | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T896107 — 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 Context triple: [ISO 14971, relatedTo, IEC 60601-1]
-
A.
ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
B.
IEEE Std 610.12-2010
IEEE Std 610.12-2010 is an updated IEEE standard that provides a formal glossary of terms and definitions used in software engineering.
-
C.
IEEE 11073 medical device communication standards
IEEE 11073 medical device communication standards are a family of international standards that define interoperable data exchange and integration between medical devices and healthcare information systems.
-
D.
ISO 13485
ISO 13485 is an international quality management standard that specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services.
-
E.
IEC 60488
IEC 60488 is an international standard issued by the International Electrotechnical Commission that defines digital interface and command protocols for programmable measuring instruments and related control systems.
- 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 Target entity description: IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
-
A.
ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
B.
IEEE Std 610.12-2010
IEEE Std 610.12-2010 is an updated IEEE standard that provides a formal glossary of terms and definitions used in software engineering.
-
C.
IEEE 11073 medical device communication standards
IEEE 11073 medical device communication standards are a family of international standards that define interoperable data exchange and integration between medical devices and healthcare information systems.
-
D.
ISO 13485
ISO 13485 is an international quality management standard that specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services.
-
E.
IEC 60488
IEC 60488 is an international standard issued by the International Electrotechnical Commission that defines digital interface and command protocols for programmable measuring instruments and related control systems.
- F. None of above. chosen
Statements (54)
| Predicate | Object |
|---|---|
| instanceOf |
IEC standard
ⓘ
international standard ⓘ medical device safety standard ⓘ |
| abbreviationOf |
IEC 60601-1
self-linksurface differs
ⓘ
surface form:
International Standard IEC 60601-1
|
| adoptedAs |
IEC 60601-1
self-linksurface differs
ⓘ
surface form:
ANSI/AAMI ES60601-1
CSA C22.2 No. 60601-1 ⓘ IEC 60601-1 self-linksurface differs ⓘ
surface form:
EN 60601-1
|
| appliesTo |
equipment detecting energy transfer to or from the patient
ⓘ
equipment transferring energy to or from the patient ⓘ equipment with a patient connection ⓘ medical electrical systems comprising multiple devices ⓘ |
| covers |
accompanying documents
ⓘ
accuracy of controls and indicators ⓘ basic safety ⓘ constructional requirements ⓘ electrical hazards ⓘ essential performance ⓘ fire hazards ⓘ marking and labeling requirements ⓘ mechanical hazards ⓘ radiation hazards ⓘ thermal hazards ⓘ |
| definesRequirementsFor |
essential performance of medical electrical equipment
ⓘ
medical electrical equipment ⓘ medical electrical systems ⓘ safety of medical electrical equipment ⓘ |
| field |
electrical safety
ⓘ
essential performance ⓘ medical electrical equipment ⓘ |
| includes |
classification of equipment
ⓘ
general requirements for testing ⓘ programmable electrical medical systems requirements ⓘ protection against electric shock ⓘ protection against excessive temperatures ⓘ protection against mechanical hazards ⓘ protection against unwanted or excessive radiation ⓘ requirements for electromagnetic disturbances immunity ⓘ |
| isBasisFor |
IEC 60601-1-10
ⓘ
IEC 60601-1-11 ⓘ IEC 60601-1-12 ⓘ IEC 60601-1 self-linksurface differs ⓘ
surface form:
IEC 60601-1-2
IEC 60601-1-6 ⓘ IEC 60601-1-8 ⓘ IEC 60601-1-9 ⓘ IEC 60601-1 self-linksurface differs ⓘ
surface form:
IEC 60601-2-xx collateral and particular standards
|
| objective |
to ensure safety of maintenance personnel
ⓘ
to ensure safety of operators ⓘ to ensure safety of patients ⓘ |
| partOfSeries |
IEC 60601-1
self-linksurface differs
ⓘ
surface form:
IEC 60601
|
| publishedBy | International Electrotechnical Commission ⓘ |
| status | widely used global benchmark for medical electrical equipment safety ⓘ |
| usedBy |
medical device manufacturers
ⓘ
regulatory authorities ⓘ 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 Description of subject: IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
Referenced by (7)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
International Standard IEC 60601-1
this entity surface form:
IEC 60601
this entity surface form:
IEC 60601-1-2
this entity surface form:
IEC 60601-2-xx collateral and particular standards
this entity surface form:
EN 60601-1
this entity surface form:
ANSI/AAMI ES60601-1