ISO 14971
E19349
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
All labels observed (4)
| Label | Occurrences |
|---|---|
| ISO 14971 canonical | 4 |
| ISO 14971:2007 | 2 |
| ISO 14971:2000 | 1 |
| ISO 14971:2019 | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T156055 — 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 14971 Context triple: [International Organization for Standardization, issuesStandard, ISO 14971]
-
A.
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.
-
B.
ISO 9001
ISO 9001 is an internationally recognized standard that specifies requirements for quality management systems to help organizations consistently meet customer and regulatory requirements.
-
C.
ISO 31000
ISO 31000 is an international standard that provides principles and guidelines for effective risk management applicable to organizations of all types and sizes.
-
D.
ISO 22000
ISO 22000 is an international food safety management standard that specifies requirements for organizations in the food chain to ensure safe food production and handling.
-
E.
ISO 45001
ISO 45001 is an international standard that specifies requirements for an occupational health and safety management system to help organizations improve worker safety and reduce workplace risks.
- 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 14971 Target entity description: ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
A.
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.
-
B.
ISO 9001
ISO 9001 is an internationally recognized standard that specifies requirements for quality management systems to help organizations consistently meet customer and regulatory requirements.
-
C.
ISO 31000
ISO 31000 is an international standard that provides principles and guidelines for effective risk management applicable to organizations of all types and sizes.
-
D.
ISO 22000
ISO 22000 is an international food safety management standard that specifies requirements for organizations in the food chain to ensure safe food production and handling.
-
E.
ISO 45001
ISO 45001 is an international standard that specifies requirements for an occupational health and safety management system to help organizations improve worker safety and reduce workplace risks.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
edition of ISO 14971
ⓘ
international standard ⓘ risk management standard ⓘ |
| addresses |
evaluation of overall residual risk
ⓘ
hazard identification ⓘ production and post-production information ⓘ risk control ⓘ risk estimation ⓘ risk evaluation ⓘ |
| aimsTo |
balance benefits and risks of medical devices
ⓘ
ensure safety of medical devices ⓘ reduce risks associated with medical devices ⓘ |
| appliesTo |
in vitro diagnostic medical devices
ⓘ
medical devices ⓘ |
| compatibleWith | quality management systems for medical devices ⓘ |
| covers | entire life cycle of medical devices ⓘ |
| defines |
harm as physical injury or damage to health of people or damage to property or the environment
ⓘ
risk as combination of probability of occurrence of harm and severity of that harm ⓘ |
| focusesOn |
benefit-risk analysis
ⓘ
post-market surveillance information ⓘ risk management ⓘ |
| geographicalScope | international ⓘ |
| hasEdition |
ISO 14971:2000
ⓘ
linked to:
ISO 14971
ISO 14971:2007 ⓘ
linked to:
ISO 14971
ISO 14971:2019 ⓘ
linked to:
ISO 14971
|
| hasStatus | active standard ⓘ |
| language | English ⓘ |
| publishedBy |
International Electrotechnical Commission
ⓘ
International Organization for Standardization ⓘ |
| relatedTo |
EU In Vitro Diagnostic Regulation
ⓘ
linked to:
European Union medical device regulations
EU Medical Device Regulation ⓘ
linked to:
European Union medical device regulations
IEC 60601-1 ⓘ ISO 13485 ⓘ |
| requires |
assessment of overall residual risk acceptability
ⓘ
evaluation of risk control measures ⓘ risk management file ⓘ risk management plan ⓘ top management responsibility for risk management ⓘ verification of implementation of risk control measures ⓘ |
| revises |
ISO 14971:2007
ⓘ
linked to:
ISO 14971
|
| sector |
healthcare
ⓘ
medical technology ⓘ |
| specifies | systematic process for risk management ⓘ |
| usedBy |
medical device designers
ⓘ
medical device manufacturers ⓘ medical device regulators ⓘ notified bodies ⓘ |
| usedFor | regulatory compliance in many jurisdictions ⓘ |
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 14971 Description of subject: ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
Referenced by (8)
Full triples — surface form annotated when it differs from this entity's canonical label.
linked to: ISO 14971
linked to: ISO 14971
linked to: ISO 14971