Las últimas listas de normas armonizadlas con los reglamentos son:
– DECISIÓN DE EJECUCIÓN (UE) 2021/1182 DE LA COMISIÓN de 16 de julio de 2021 para MDR
– DECISIÓN DE EJECUCIÓN (UE) 2021/1195 DE LA COMISIÓN de 19 de julio de 2021 para IVDR
Tenemos en la línea de salida estas de publicación inminente para MDR:
– EN ISO 10993-9:2021 Biological evaluation of medical devices: Framework for identification and quantification of potential degradation products
– EN ISO 10993-12:2021 Biological evaluation of medical devices: Sample preparation and reference materials
– EN ISO 11737-1:2018+/A1:2021 Sterilization of health care products – Microbiological methods: Determination of a population of microorganisms on products
– EN ISO 13408-6:2021 Aseptic processing of health care products: Isolator systems
– EN ISO 13485:2016+/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes
– EN ISO 14160:2021 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives
– EN ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer: General requirements
– EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices: Critical and semi-critical medical devices
– EN IEC 60601-2-83:2020+A11:2021 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
Seguiremos informando …