Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)
Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999)
Dentistry - Amalgam capsules (ISO 13897:2003)
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
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