Chapter A: General and technical data 5 Technical specifications
Technical manual Planmeca PlanMill 40 13
5.2 Approvals
Packaging and environmental ISTA Class 2B
Additional standards ISO 13485: 2003
FDA Class II Special Controls for Computer
Assisted Design and Manufacturing of Dental
Restorations
European Directives 2006/42/EC for Machinery
North America Product Safety Mark (NRTL) - UL C/US
International CB Scheme Test Certificate (UL)
Quality System Certifications ISO 13485 Registered Firm
CMDCAS (Canada)
Japan GMP