Fluidigm CyTOF XT - Regulatory Compliance; General Regulations and Requirements; Harmonized Standards; Conformity Symbols on the Instrument

Chapter 1: Product Overview
Regulatory Compliance
CyTOF XT User Guide 15
Regulatory Compliance
The following directives and harmonized standards were used to evaluate the safety and
performance of the CyTOF XT system:
General Regulations and Requirements
• 2014/35/EU European Parliament Low Voltage Directive
• 2014/30/EU European Parliament Directive: Electromagnetic Compatibility
• 2006/42/EU Machinery Directive
Harmonized Standards
• IEC/EN 61326-1
• IEC/EN 61010-1
• IEC/EN 61010-2-081
• UL Standard Number 61010-1 2nd Edition
• CAN/CSA-C22.2 No. 61010-1-04
• FCC Part 15 Subpart B & ICES-003:2019
• EN ISO 12100
Conformity Symbols on the Instrument
The instrument is labeled with the following conformity markings:
Conformity Mark
Description
Indicates conformity with safety requirements for Canada and the United
States.
Indicates conformity with European Union requirements for safety and
electromagnetic compatibility
AZ
Refer to the CyTOF XT Site Requirements Guide (FLDM-00360) for more detailed
information on the recommended environmental conditions.