Standards
The TruNode®
system complies with the following standards:
Safety
• IEC 60601-1 (2014) 4th Ed. Medical Electrical Equipment - Part 1:
General requirements for basic safety and essential performance
Biocompatibility
• ISO 10993 (including ETO residuals): Biological evaluation of medical
devices: cytotoxicity, sensitization, irritation; externally
communicating device; <24hrs exposure
Sterilization
• ISO 11135: Validation and routine control of ethylene oxide
sterilization
• ISO 11607-1:2009+A1:2014: Packaging for Terminally Sterilized
Medical Devices
Regulatory
• Medical Devices Directive 93/42/EEC amendment 2007/47/EC,
Class IIa
Electromagnetic Compatibility
• EMC Directive 2004/108/EC Group l, Class B
• EN ISO 60601-1-2:2014 Medical Electrical Equipment - Part 1: General
Requirements For Safety - Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests
Wireless Operation
• Radio Equipment Directive 2014/53/EU
• FCC Part 15C: Intentional Radiators – FCC ID 2ADNA-S10 (Probe)
& QISCPN-W09 (Huawei Tablet) or ZCASMT-290 (Samsung
tablet)
• Wireless: Bluetooth 4.0BLE
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