User's Manual

User Manual
Manual No. AMSL/DMR/UM/FD 009
Rev. 00 Effective Date 12.07.2022 Page | 13
3. Safety and Regulatory
This Allengers 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.
3.1 Compliance Standards and Classification
3.1.1. Compliance Standards
List of standards for the evaluation of product compliance
Reference
Description
AAMI / ANSI ES60601
-1:2005/ (R)2012 And
A1: 2012,C1: 2009/(R)
2012 And A2:2010/
(R)2012
(Consolidated Text)
Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential
Performance (IEC 60601-1:2005, Mod). (General
II (ES/EMC))
IEC 60601-1-2: 2014
Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential
Performance - Collateral Standard:
Electromagnetic Compatibility - Requirements
And Tests
IEC 62304 Edition 1.1
2015-06 CONSOLIDATED
VERSION
Medical device software - Software life cycle
processes
IEC 60601-1-6 Edition
3.1 2013-10
Medical Electrical Equipment - Part 1-6: General
Requirements For Basic Safety And Essential
Performance - Collateral Standard: Usability.
(General I (QS/RM))
ANSI AAMI IEC 62366-1
Edition 1.0 2015-02
Medical devices - Part 1: Application of usability
engineering to medical devices [Including
CORRIGENDUM 1 (2016)]
ISO 10993-1 Fifth edition
2018-08
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process