IEC 62304
E1103986
UNEXPLORED
IEC 62304 is an international standard that defines life cycle requirements for the development and maintenance of medical device software.
All labels observed (1)
| Label | Occurrences |
|---|---|
| IEC 62304 canonical | 4 |
How this entity was disambiguated
This entity first appeared as the object of triple T14538955 — 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 62304 Context triple: [QNX, supportsCertification, IEC 62304]
-
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.
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
IEC 60601 is an international standard that specifies safety and essential performance requirements for medical electrical equipment.
-
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 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 62304 Target entity description: IEC 62304 is an international standard that defines life cycle requirements for the development and maintenance of medical device software.
-
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.
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
IEC 60601 is an international standard that specifies safety and essential performance requirements for medical electrical equipment.
-
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 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
Referenced by (4)
Full triples — surface form annotated when it differs from this entity's canonical label.