Use Instructions

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Chapter 8: Applied Standards
Standard number Description
IEC 60601-1:
2005+A1:2012
General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:
2010+A1:2013
Collateral standard: Usability
IEC 60601-1-11: 2015
Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in homecare environment
IEC 60601-2-10: 2012
Particular requirements for the basic safety and essential performance of nerve and
muscle stimulators
IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes
IEC 62304:
2006+A1:2015
Medical device software - Software life cycle processes
ISO 15223-1: 2016
Symbols to be used with medical devices labels, labeling and information to be
supplied
ANSI/AAMI EC12:
2000/(R)2015
Disposable ECG Electrodes
FCC 47 CFR Part 15
Subpart C
Radio Frequency Devices: Intentional Radiators
ISO 10993-5:
2009/(R)2014
Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity
ISO 10993-10:
2010/(R)2014
Biological Evaluation of Medical Devices: Tests for irritation and skin sensitization
ISO 14971: 2007
Application of Risk Management to Medical Devices