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Section 8: Standards Compliance
This device is designed to comply with the following standards:
IEC 60601-1 2020 Edition 3.2; Medical Electrical Equipment; Part 1: General
Requirements for Basic Safety and Essential Performance
IEC 60601-1-2 Edition 4.1 2020; Medical Electrical Equipment, Part 1-2:
General Requirement for Safety
– Collateral Standard: Electromagnetic
(EMC) Compatibility
IEC 60601-1-6 Edition 3.2 2020 Medical Electrical Equipment
– Part 1-6
General Requirements for Basic Safety and Essential Performance
– Collateral
Standard: Usability
IEC 60601-1-8 Edition 2.2 2020 Medical Electrical Equipment
– Part 1-8:
General Requirements for Basic Safety and Essential Performance
– Collateral
Standard: General Requirements Tests and Guidance for Alarm Systems in
Medical Electrical Equipment and Medical Electrical Systems
IEC 60601-1-11 Edition 2.1 2020 Medical Electrical Equipment Part 1-11:
General Requirements for Basic Safety and Essential Performance Collateral
Standard
– Requirements for Medical Electrical Equipment and Medical
Electrical Systems Used in the Home Healthcare Environment
IEC 62304 Edition1.0 + A1 2015 Medical Device Software
– Software Life
Cycle Processes
AAMI IEC 62366 Edition 1.0 + A1 2020 Medical Devices
– Application of
Usability Engineering to Medical Devices (R2013)
ISO 80601-2-67 Edition 2.0 2020 Medical Electrical Equipment
– Part 2- 67
Particular Requirements for Basic Safety and Essential Performance of Oxygen
Conserving Equipment
ISO 80601-2-69 Edition 2.0 2020 Medical Electrical Equipment
– Part 2- 69
Particular Requirements for Basic Safety and Essential Performance of Oxygen
Concentrator Equipment
RTCA, DO-160G, Section 21, Category M; Emission of Radio Frequency Energy
ISO 13485:2016 Medical Devices; Quality Management Systems; Requirements
for Regulatory Purposes