Operation Manual

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© Prognosys Medical Systems Private Limited│ X-Ray Products
Chapter 2 Safety and Regulatory
This PRORAD X-Ray Flat Panel Detector has been designed and tested to function in a safe and
correct when used as indicated in this manual. Do not use this device before reading and
completely understand this Operation Manual. Always observe precautions for safety and only
operates the device in a qualified room that provides protection.
2.1 Compliance Standards and Classification
2.1.1 Compliance Standards
- FDA Standards 21 CFR 1020.31 for ionizing radiation emitting products
- FDA Standards 21 CFR 892.1680 for stationary x-ray system
- FCC part15
- European Medical Devices Directive (93/42/EEC)
- EN ISO 13485:2016
- ISO 14971:2019
- EN 60601-1: 2006+A1: 2013
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
- CAN/CSA C22.2 No. 60601-1:14
- EN 60601-1-2:2015
- IEC 62304:2006/Amd 1:2015
- EN 60601-1-6: 2010+A1:2015
- EN 62366-1: 2015
- ISO 10993-1:2018
- EN ISO 10993-5:2009
- ISO 10993-10:2010