Hologic Faxitron CT - DICOM Standard

Faxitron CT Specimen Radiography System User Guide
Chapter 2: General Information
Page 16 5081-9544 Revision 004
• EN 55011 and CISPR 11 (Class A) - Industrial, Scientific and Medical (ISM) Radio-
Frequency Equipment – Electromagnetic Disturbance Characteristics - Limits and
Methods of Measurement
• EN ISO 14971 – Medical Devices – Application of risk management to medical
devices
• EN ISO 13485 Medical Devices – Quality management systems – requirements for
regulatory purposes
• EN ISO 18113-1 In vitro diagnostic medical devices – Information supplied by the
manufacturer (labeling) Part 1: Terms, definitions, and general requirements
• EN ISO 18113-3 In vitro diagnostic medical devices – Information supplied by the
manufacturer (labeling) Part 3: In vitro instruments for professional use
• EN ISO 15223-1 Medical Devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
CFR:
• 21 CFR § 1020.40 - Cabinet X-ray Systems
• 47 CFR Part 15.5 - General Conditions of Operation
CAN/CSA:
• CAN/CSA-C22.2 No. 61010-1, 3rd Edition - Safety Requirements for Electrical
Equipment for Measurement, Control, and Laboratory Use – Part 1: General
Requirements
2.6 DICOM Standard
Faxitron CT uses the latest DICOM Standard:
• NEMA PS3 / ISO 12052, Digital Imaging and Communications in Medicine (DICOM)
Standard, National Electrical Manufacturers Association, Rosslyn, VA, USA
(available free at http://www.dicomstandard.org/)
• See Faxitron CT DICOM Conformance Statement for more information.