NEN-EN- ISO 149: 20en. Medische hulpmiddelen - Toepassing van risicomanagement voor medische hulpmiddelen (corrected and reprinted). This European Standard was approved by CEN on June 2009. There is no ISO 149: 20but there is a correction done to the ISO . Be notified when this Standard is updated or amended - Add to.
Application of risk management to medical devices. International Standard ISO 149was prepared by ISO/TC 21 Quality management and corresponding general aspects for medical devices, and . ISO 149is an ISO standard for the application of risk management to medical devices. The latest significant revision was published in 20with a minor update published in 2009.
In 201 a technical report ISO/TR 249was published . Complying with ISO 149: Transition from 20to 20presented by John Beasley Owner . Status: Alert Tilbaketrukket. Norsk tittel: Medisinsk utstyr - Bruk av risikostyring for medisinsk utstyr ( ISO 149:200 korrigert versjon 2007-10-01). During the process of harmonisation of ISO 14971: 20as an EN standar. EN ISO 149- Transitioning to 20version.
ALARP) as stated in the ISO 149: 2009.
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