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11 APPENDIX B – Security standards
11 APPENDIX B – Security standards
The NewTom 5G equipment has been built in conformity with IEC normative regarding safety of electric-
medical devices of similar typology and, particularly, with the normative:
•
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) - General requirements for basic safety
and essential performance.
•
IEC 60601-1-2: 2007 (3rd Ed.) - Electromagnetic compatibility - Requirements and tests – See
clause 17;
•
IEC 60601-1-3:2008 (2nd Ed.) - Radiation protection in diagnostic X-ray equipment
•
IEC 60601-1-6:2010 (3rd Ed.) - General requirements for safety - Collateral Standard: Usability
including
•
IEC 60601-2-28: 2010 (2nd Ed.) - Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis
•
IEC 60601-2-44: 2009 (3rd Ed.) - Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
•
IEC 60825-1: 1993 + A1:1997 + A2:2001 - Safety of laser products - Part 1: Equipment
classification, requirements and user's guide
•
IEC 62304 Edition 1.0b: 2006 Medical device software - Software life cycle processes
•
IEC 62366: 2007 (1st Edition) Medical devices - Application of usability engineering to medical
devices
•
ANSI/AAMI ES60601-1: 2005 / A2:2010 -Medical electrical equipment, Part 1: General
Requirements
•
CAN/CSA-C22.2 No. 60601-1:08 Medical Electrical Equipment - Part 1: General Requirements
for Safety
IEC 601-1 CLASSIFICATION
Protection against electrical shock CLASS I
Degree of protection against electric shock TIPE B
Use with flammable anesthetics Have not been evaluated for use in the presence of a
flammable anaesthetic mixture with air, oxygen, or
nitrous oxide.
Sterilization and disinfection methods The device is supplied not sterile and it must not be
subjected to sterilization.
(See Par. 3.5- “Cleaning and disinfection“)
Mode of operation Continuous with intermittent loading.
Duty cycle atient support – movements:
16% (2.20 min / 15 min)
Gantry – movements:
14% (2 min / 15 min)
X-ray operating:
2.7% max. 24 sec. / 15 min for standard resolutions
4% max. 36 sec. / 15 min for HiRes resolutions
Planned time of use 10 years, by following the instructions for use
NewTom 5G – User Manual 11-1