Planmeca Emerald - Packaging and Environmental; Biocampatibility; European Standards; Canadian Standards

Packaging and Environmental
ISTA Class 2A
Biocampatibility
ISO 10993
European Standards
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
Canadian Standards
CAN/CSA C22.2 No. 60601
SOR-98-282 Canada Medical Device Regulations
ICES-001 ISM Radio Frequency Generators
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
International Standards
ISO 14971:2007
ISO 13485:2003
Approvals (All Systems)
North America Product Safety Mark (NRTL) - UL C/US
International CB Scheme Product Safety Test Certicate (UL)
CB Scheme EMC Test Certicate (INTERTEK)
CE Mark (TUV)
Quality System Certications ISO 13485 Registered Firm
Complies with FDA performance standards for laser products, except for deviations pursuant to Laser Notice No. 50,
dated June 24, 2007.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)
This device may not cause harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
48 Planmeca Emerald Specications Planmeca Emerald User Manual