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Medical devices. Guidance on the application of ISO 14971 Ingestion-build-135476 Section 9: Fatigue
Medical devices. Guidance on the application of ISO 14971 Ingestion-build-135476 Section 9: Fatigue
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Description
Section 9: Fatigue
they’ll be able to prove:
BS EN 14399-3:2005
a part of the BS EN 527 series
Risk acceptance
Medical devices. Guidance on the application of ISO 14971 Ingestion-build-135476 Section 9: FatigueWhat is this published document about? Experience shows that manufacturers have difficulty with the practical implementation of some clauses in the medical devices risk management standard BS EN ISO 14971. This published document is the UK implementation of an international Technical Report. It supplies guidance on tackling specific clauses in the standard. Who is this published document for? Medical device manufacturers Regulators Other users of BS
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