Uusi julkaisu ei juurikaan pura julkaisemista odottavien standardien sumaa mutta muutama tärkeä uusi standardiversio on mukana:
EN ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
EN ISO 15223-1:2016
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
EN 60601-2-33:2010, A1:2015, A2:2015 ja A12:2016
Medical electrical equipment — Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
EN 60601-1-8:2007/A11:2017
Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
EN 60601-1-3:2008/A11:2016
Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment
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