Hologic Selenia - Page 28

Selenia User Guide
Chapter 2—General Information
16 MAN-03270 Revision 003
• IEC 60601-1-1Ed. 2.0:2000 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety Requirements for Medical
Electrical Systems
• 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; also IEC 60601-1-3 Ed. 1.0:1994
Medical Electrical Equipment – Part 1: General Requirement for Safety -3. Collateral
Standard: Requirements for Radiation Protection in Diagnostic X-ray Equipment
• IEC 60601-1-4 Ed. 1.1:2000 Medical Electrical Equipment – Part 1-4: General
Requirements for Safety - Collateral Standard: Programmable Electrical Medical
Systems
• 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; also IEC 60601-2-28 Ed. 1.0:1993 Medical Electrical
Equipment – Part 2: Particular Requirements for the Safety of X-Ray Source
Assemblies and X-ray Tube Assemblies for Medical Diagnosis
• IEC 60601-2-32 Ed. 1.0:1994 Medical Electrical Equipment – Part 2: Particular
Requirements for the Safety of Associated Equipment of X-ray Equipment
• 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; also IEC 60601-2-45 Ed. 2.0:2001
Medical Electrical Equipment Part 2-45: Particular Requirements for the Safety of
Mammographic X-ray Equipment and Mammographic Stereotactic Devices
• 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); also UL 60601-1 1st Edition: Medical Electrical Equipment, Part
1—General Requirements for Safety