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ISO 14971

Status:

PUBLISHED

As of:

Dec 2019; amended 2021; continuously recognized by regulators (e.g. FDA, EU MDR)

Region(s):

Global / adopted nationally (e.g. EN ISO 14971 in EU)

Body:

International Organization for Standardization (ISO), Technical Committee ISO/TC 210 with IEC/SC 62A (JWG1)

Applicable to:

Medical devices, The outline for the future UL 2900-2-3 standard says it “applies to the evaluation of security and life safety signaling system components,” including these:, Healthcare

Summary:

Structure includes clauses on policy, analysis, evaluation, control, residual risk, review, production/post-production info; annexes provide rationale and guidance; traceability requirements; risk acceptability criteria; maintenance of risk management file