ISO 13485
E18757
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| ISO 13485 canonical | 3 |
How this entity was disambiguated
This entity first appeared as the object of triple T156048 — 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: ISO 13485 Context triple: [International Organization for Standardization, issuesStandard, ISO 13485]
-
A.
European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare is a Council of Europe body responsible for developing quality standards and guidance to ensure the safety and efficacy of medicines and improve healthcare across member states.
-
B.
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.
-
C.
International Organization for Standardization
The International Organization for Standardization (ISO) is an independent, non-governmental international body that develops and publishes globally recognized standards to ensure quality, safety, efficiency, and interoperability across a wide range of industries and technologies.
-
D.
Joint Commission
The Joint Commission is an independent, nonprofit organization that accredits and certifies healthcare organizations and programs in the United States to promote quality and patient safety.
-
E.
HL7 standards
HL7 standards are a widely adopted set of international specifications for the exchange, integration, sharing, and retrieval of electronic health information between healthcare 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: ISO 13485 Target entity description: 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.
-
A.
European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare is a Council of Europe body responsible for developing quality standards and guidance to ensure the safety and efficacy of medicines and improve healthcare across member states.
-
B.
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.
-
C.
International Organization for Standardization
The International Organization for Standardization (ISO) is an independent, non-governmental international body that develops and publishes globally recognized standards to ensure quality, safety, efficiency, and interoperability across a wide range of industries and technologies.
-
D.
Joint Commission
The Joint Commission is an independent, nonprofit organization that accredits and certifies healthcare organizations and programs in the United States to promote quality and patient safety.
-
E.
HL7 standards
HL7 standards are a widely adopted set of international specifications for the exchange, integration, sharing, and retrieval of electronic health information between healthcare systems.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
international standard
ⓘ
medical device standard ⓘ quality management system standard ⓘ |
| abbreviationOf | International Organization for Standardization 13485 ⓘ |
| aimsTo |
ensure consistent design of safe medical devices
ⓘ
ensure consistent production of safe medical devices ⓘ support regulatory compliance for medical devices ⓘ |
| appliesTo |
organizations involved in design of medical devices
ⓘ
organizations involved in installation of medical devices ⓘ organizations involved in production of medical devices ⓘ organizations involved in servicing of medical devices ⓘ organizations providing related medical device services ⓘ |
| basedOn | ISO 9001 principles ⓘ |
| contains |
requirements for management responsibility
ⓘ
requirements for measurement, analysis and improvement ⓘ requirements for product realization ⓘ requirements for resource management ⓘ |
| emphasizes |
customer and regulatory authority satisfaction
ⓘ
product realization processes ⓘ regulatory compliance ⓘ risk-based approach to medical device quality ⓘ |
| focusesOn | quality management systems for medical devices ⓘ |
| hasType | voluntary consensus standard ⓘ |
| language | English ⓘ |
| publishedBy | International Organization for Standardization ⓘ |
| relatedTo |
European Union medical device regulations
ⓘ
FDA quality system regulation for medical devices ⓘ |
| relevantTo |
medical device design organizations
ⓘ
medical device distributors ⓘ medical device manufacturers ⓘ medical device service providers ⓘ sterilization service providers for medical devices ⓘ |
| scopeIncludes |
complaint handling
ⓘ
control of monitoring and measuring equipment ⓘ corrective and preventive actions ⓘ design and development controls ⓘ document control ⓘ production and process controls ⓘ purchasing controls ⓘ record control ⓘ regulatory requirements for medical devices ⓘ risk management for medical devices ⓘ sterile medical device controls ⓘ traceability requirements ⓘ validation of processes for production and service provision ⓘ |
| usedFor |
certification of medical device manufacturers
ⓘ
certification of medical device suppliers ⓘ demonstrating conformity to regulatory requirements ⓘ |
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: ISO 13485 Description of subject: 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.
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.