Table of Contents
Advertisement
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader,
General
• The digitizer has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).
• The cassette adapter has been designed in accordance with Regulation
(EU) 2017/745 on medical devices (MDR).
• ISO 13485
• IEC 62366
• IEC 62304
• ISO 14971
Safety
• IEC 60601-1
• UL 60601-1
• AAMI/ANSI ES 60601-1
• CAN/CSA C 22.2 No.60601.1
Laser Safety
• IEC 60825-1
Electromagnetic Compatibility
• IEC 60601-1-2
• FCC Rules 47 CFR part 15 subpart B
• CAN/CSA 22.2 No. 60601-1-2
Environmental Compliance
• WEEE 2012/19/EC
• RoHS 2 Directive 2011/65/EU
CR Advanced Reader and CR Multiformat Reader | 23
2591D EN 20191028 1712
Advertisement
Table of Contents
