Regulatory Information
10-2 Safety Standards & Specifications
Regulatory Information
Software Hazard Prevention
Potential hazards arising from errors in the software program have been
identified. Mitigations applied to reduce the associated risk of such hazards
are included as part of the Risk Management, Clinical Evaluation, and
Verification and Validation phases of the product’s development.
AC Power Source
The system is not intended for connection to the public mains as defined in
CISPR-11.
Industrie Canada Compliance (Canada)
This Class B ISM device complies with Canadian ICES-001.
Cet ISM de la classe B est conforme à la norme NMB-001 du Canada.
Safety Standards
The device complies with the following safety requirements for medical
electrical equipment:
• EN 60601-1:2006 +A1: 2013, Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC 60601-1:2005 + A1: 2012
• EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, Medical electrical
equipment -- Part 1: General requirements for basic safety and essential
performance
IEC 60601-1:1988 + A1:1991 + A2:1995
• EN ISO80601-2-49:2018 Medical electrical equipment – Part 2: Particular
requirements for Safety
• CAN/CSA C22.2 601.1-M90: Medical Electrical Equipment part 1: General
requirements for Safety
• UL 60601-1 Medical Electrical Equipment - General Safety
• EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General
requirements for safety - Collateral standard: Safety requirements for
medical electrical systems
IEC 60601-1-1:2000
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