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8. STANDARDS AND REGULATIONS
EN 60601-1:2006+A2:2021
Medical electrical equipment - Part 1: General basic
safety and essential performance requirements
EN 60601-1-2:2015+A1:2021
Medical Electrical Equipment - Part 1-2:
General Basic Safety and Essential Performance
Requirements
- Collateral standard: electromagnetic disturbances
EN 62471:2008
Photobiological safety of lamps and lamp systems
EN 80601-2-60:2020
Medical electrical equipment - Part 2-60: Particular
requirements for basic safety and essential
performance of dental equipment
EN 60601-1-6:2010+A2:2021
Electromedical Equipment - Part 1-6: General
requirements for basic security and essential
performance - Collateral standard: Usability;
EN 60601-1-9:2008+A2:2020
Medical electrical equipment - Part 1-9: General
requirements for basic security and essential
performance - Collateral standard: Requirements
for environmentally conscious design
EN ISO 15223-1:2021
Graphic symbols for electrical equipment in
medical practice
EN 20417:2021
Information provided by manufacturer of medical
devices.
EN ISO 13485:2016+A11:2021
Quality management systems - Requirements for
regulatory purposes
EN ISO 10993-1:2020
Biological evaluation of medical devices - Part 1:
Evaluation and tests.
EN ISO 14971:2019
Medical Devices - Application of risk management
to medical devices.
This equipment has been designed and manufactured to meet the following standards:
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