ISO 14971

E19349
edition of ISO 14971 international standard risk management standard

ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.

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Observed surface forms (3)

Surface form Occurrences
ISO 14971:2019 1
ISO 14971:2007 2
ISO 14971:2000 1

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 self-linksurface differs ⓘ
surface form: ISO 14971:2000

ISO 14971 self-linksurface differs ⓘ
surface form: ISO 14971:2007

ISO 14971 self-linksurface differs ⓘ
surface form: ISO 14971:2019
hasStatus active standard ⓘ
language English ⓘ
publishedBy International Electrotechnical Commission ⓘ
International Organization for Standardization ⓘ
relatedTo European Union medical device regulations ⓘ
surface form: EU In Vitro Diagnostic Regulation

European Union medical device regulations ⓘ
surface form: EU Medical Device Regulation

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 self-linksurface differs ⓘ
surface form: ISO 14971:2007
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 ⓘ

Referenced by (5)

Full triples — surface form annotated when it differs from this entity's canonical label.

ISO 14971 → hasEdition → ISO 14971 self-linksurface differs ⓘ
this entity surface form: ISO 14971:2000
ISO 14971 → hasEdition → ISO 14971 self-linksurface differs ⓘ
this entity surface form: ISO 14971:2007
ISO 14971 → hasEdition → ISO 14971 self-linksurface differs ⓘ
this entity surface form: ISO 14971:2019
ISO 14971 → revises → ISO 14971 self-linksurface differs ⓘ
subject surface form: ISO 14971:2019
this entity surface form: ISO 14971:2007