Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 29 of 101
3. Safety Information
This section is intended to provide users with safety information in order to operate the device safely and
as intended.
3.1. Certifications
3.1.1. HFC – Handheld Fluorescence Camera
• ISO 10993-1:2018 Evaluation of Medical Devices – Part 1: Evaluation of and Testing Within a Risk
Management Plan
• ISO 17664:2017 Processing of Health Care Products – Information to be Provided by the Medical Device
Manufacturer for the processing of Medical Devices
• IEC 60601-1:2005 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and
Essential Performance
• IEC 60601-1-6:2010 Medical Electrical Equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral standard: Usability
• IEC 62366-1:2015 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
• IEC 60601-2-18:2019 Medical Electrical Equipment – Part 2-18: Requirements for the Basic Safety and
Essential Performance of Endoscopic Equipment
• 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 62471 Photobiological Safety of Lamps and Lamp Systems
• IEC 62133-2 Secondary Cells and batteries containing alkaline or other non-acid electrolytes: Safety
requirements for portable sealed secondary cells, and for batteries made from them, for use in portable
applications – Part 2: Lithium systems
3.1.2. CSS – Custom Sterile Sleeve
• ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
• ISO 11135:2014 Sterilization of Health Care Products -Ethylene Oxide –
Requirements for the
development, validation and routine control of a sterilization process for medical devices
3.1.3. ECH – External Communications Hub
• ISO 17664:2017 Processing of Health Care Products – Information to be Provided by the Medical Device
Manufacturer for the processing of Medical Devices