2022UNE-EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2018UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
2013UNE-EN ISO 13485:2013 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)