Brevera Breast Biopsy System User Guide
Chapter 2: General Information
MAN-04303-002 Revision 006 Page 15
Caution:
The Medical Electrical (ME) Equipment or ME System should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary, make sure
that the ME Equipment or ME System operates correctly in this configuration.
Caution:
Changes or modifications not expressly approved by Hologic could void your
authority to operate the equipment.
2.5.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
• IEC 60601-1: 2005/A1: 2012 ed. 3.1 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance
• ANSI/AAMI ES60601-1: A1: 2012, C1: 2009/(R)2012 and A2: 2010/(R)2012 Medical
Electrical Equipment -- Part 1: General Requirements for Basic Safety and Essential
Performance
• CAN/CSA-C22.2 No. 60601-1 (2014) Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential Performance
• EN 60601-1: 2006 / A1: 2013 Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2 ed. 4: 2015 Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential Performance - Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
• IEC 60601-1-6: 2010/AMD1: 2013 and IEC 62366: 2007/AMD1: 2014 Application of
Usability Engineering to Medical Devices
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