Standard Number
BS EN ISO 13485:2012
Title
Medical devices. Quality management systems. Requirements for regulatory purposes
Status
Current
Publication Date
31 March 2012
Cross References
90/385/EEC, 93/42/EEC, 98/79/EC, ISO 9000:2000, ISO 9001:2000, ISO 10012, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 13683:1997, ISO 14155-1:2003, ISO 14155-2:2003, ISO 14160:1998, ISO 14937:2000, ISO/TR 14969, ISO 14971:2000, ISO 19011:2002
Replaces
BS EN ISO 13485:2003