Hologic Trident HD - Compliance Statements

Trident HD Specimen Radiography System User Guide
Chapter 2: General Information
Page 12 MAN-05478-002 Revision 003
2.5.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
UL, IEC, EN:
• UL 61010-1: 2012 - Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use; Part 1: General Requirements
• IEC 61010-1 § 6.7
• IEC 61010-1: 2010, 3rd Edition - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use; Part 1: General Requirements
• IEC 61010-2-091: 2012, 3rd Edition - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use; Part 2-091: Particular Requirements for
Cabinet X-ray Systems
• EN 61326-1: 2013 Electrical Equipment for Measurement, Control, and Laboratory
Use – EMC Requirements, General Requirements
• EN 55011 and CISPR 11 (Class A) - Industrial, Scientific and Medical (ISM) Radio-
Frequency Equipment – Electromagnetic Disturbance Characteristics - Limits and
Methods of Measurement
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