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Idiomas disponibles
Idiomas disponibles
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 & 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: Requirements for basic
safety and essential performance of oxygen conserving equipment
- ISO 80601-2-69, Medical electrical equipment, Part 2-69: Requirements for basic
safety and essential performance of oxygen concentrator equipment
- ISO18562-1: 2017 Biocompatibility, evaluation of breathing gas pathways in healthcare
applications -- Part 1: Evaluation and testing within a risk management process
- ISO18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare
applications -- Part 2: Tests for emissions of particulate matter
- ISO18562-3: 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/ANSIISO 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
- ISO 14971: 2019, Medical devices — Application of risk management to medical
devices
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