30 SCANNER SPECIFICATIONS
160 Planmeca Chairside CAD/CAM solution
User’s manual
30.1 Applicable standards
30.1.1 Product safety
ANSI/AAMI ES60601-1:2005
IEC 60601-1, 3rd Edition
30.1.2 EMC
IEC 60601-1-2
US FCC CFR 47, Part 15
30.1.3 Laser product safety
IEC 60825-1
30.1.4 Packaging and environmental
ISTA Class 2A
30.1.5 Bio-compatibility
ISO 10993
30.1.6 European standards
EN 60601-1:2006
93/42/EEC Medical Device Directive
EN 60601-1:2006 Safety of Medical Electric Equipment
EN 60601-1-2 Electromagnetic Compatibility
EN 60825-1 Safety of Laser Products
EN ISO 14971:2012 Risk Management
EN ISO 13485 Quality Management Systems
EN ISO 10993: Biological Evaluation of Medical Devices
30.1.7 Canadian standards
CAN/CSA C22.2 No. 60601-1:2008
SOR-98-282 Canada Medical Device Regulations
ICES-001 ISM Radio Frequency Generators
30.1.8 US Food and Drug Administration
US FDA CFR 21 Part 1040.10 Laser Products
US FDA Laser Notice 50
CFR 21, Part 820
FDA Class II Special Controls for Computer Assisted
Design and Manufacturing of Dental Restorations
30.1.9 International standards
ISO 14971:2007
ISO 13485:2003
