31 MILLING UNIT SPECIFICATIONS
164 Planmeca Chairside CAD/CAM solution
User’s manual
31.1 Applicable standards
Electrical and mechanical safety
UL 61010-1:2004 w/Rev 2008
CSA C22.2 No. 61010.1.04 w/Rev 2008
IEC 61010-1:2001, 2nd Edition
EN 61010-1
EMC
IEC/EN 61326
Packaging and environmental
ISTA Class 2B
Additional standards
ISO/EN 14971
EN ISO 13485:2003/AC:2009
ISO 13485: 2003
CFR 21, Part 820
SOR-98-282 Canada Medical Device Regulations
FDA Class II Special Controls for
Computer Assisted Design and Manufacturing of
Dental Restorations
European Directives
•
93/42/EEC for Medic
a
l Device
s
•
2006/42/EC for M
a
chinery
•
1999/5/EC for R
a
dio & Telecom
31.2 Approvals
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
Содержание Chairside PlanCAD Easy
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