Standards Compliance - RHYTHM P2 Manual

System Specifications

Standards Compliance

The device is designed to conform to the following standards:
- IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
- IEC 60601 - 1 - Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
- AAMI ES60601-1 - Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
- IEC 60601-1-8 - 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 - 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
- ISO 80601-2-67 - Medical electrical equipment - Part 2-67: Particular requirements for
basic safety and essential performance of oxygen-conserving equipment
- ISO 80601-2-69 - Medical electrical equipment - Part 2-69: Particular requirements for
basic safety and essential performance of oxygen concentrator equipment
- ISO 18562-1:2017 - Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing within a risk management
process
- ISO 18562-2:2017 - Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3:2017 - Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 3: Tests for emissions of volatile organic compounds
(VOCs)
- ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process
- AAMI/ANSI/ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10:
Tests for skin irritation
- AAMI/ANSI/ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity
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