3Dimensions System User Guide
Chapter 2: General Information
Page 20 MAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
2.6.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
Medical – Applied electromagnetic radiation equipment as to electrical shock, fire and
mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005) and
CAN/CSA-C22.2 No. 60601-1 (2008)
• CAN/CSA - ISO 13485-03 Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes (Adopted ISO 13485:2003 second edition,
2003-07-15)
• CAN/CSA C22.2 NO. 60601-1-08 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005,
third edition, 2005-12), includes Corrigendum 1:2011
• EN 60601-1:2006 Medical Electrical Equipment. General Requirements for Basic
Safety and Essential Performance
• ETSI EN 300 330-1: V1.3.1, and ETSI EN 300 330-2: V1.5.1: 2006—Electromagnetic
compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio
equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in
the frequency range 9 kHz to 30 MHz
• ETSI EN 301 489-1: V1.6.1, and ETSI EN 301 489-3: V1.8.1: 2008—Electromagnetic
compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility
(EMC) standard for radio equipment and services
• FCC, 47 CFR Part 15, Subpart C, Section 15.225: 2009
• FDA, 21 CFR [Parts 820, 900 and 1020]
• IEC 60601-1 Ed. 3.0:2005 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential Performance - Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
• IEC 60601-1-3 Ed. 2.0:2008 Medical Electrical Equipment – Part 1-3: General
Requirements for Basic Safety and Essential Performance –Collateral Standard:
Radiation Protection in Diagnostic X-Ray Equipment
• IEC 60601-2-28 Ed. 2.0:2010 Medical Electrical Equipment - Part 2-28: Particular
Requirements for the Basic Safety and Essential Performance of X-ray Tube
Assemblies for Medical Devices
• IEC 60601-2-45 Ed. 3.0:2011 Medical Electrical Equipment – Part 2-45: Particular
Requirements for Basic Safety and Essential Performance of Mammographic X-Ray
Equipment and Mammographic Stereotactic Devices
• RSS-210: Issue 7, 2007 Radio Standards Specification Low-power License-exempt
Radiocommunication Devices: Category I Equipment
• ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) Medical Electrical Equipment,
Part 1: General Requirements for Basic Safety and Essential Performance, includes
amendment (2010)
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