BIOFLEX Therapist - Safety Standards

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Safety Standards
This product is classified as medical equipment and has been
tested to comply for the following standards:
Canadian standards
• CAN/CSA C22.2 No. 60601.1, Third ed. - Medical Electrical
Equipment - Part 1: General Requirements for Safety
• CAN/CSA C22.2 No. 601-1.M90 - Medical Electrical Equipment
– Part 1: General Requirements for Safety
• Canadian and United States of America standards
• UL 60601-1, First ed. - Medical Electrical Equipment - Part 1:
General Requirements for Safety
• 21 CFR 1040 - Performance Standards for Light-Emitting
Products
International standards
• IEC/EN 60601-1, Second ed. - Medical Electrical Equipment -
Part 1: General Requirements for Safety
• ANSI/AAMI ES60601-1:2005 - Medical electrical equipment
- Part 1: General requirements for basic safety and essential
performance
• IEC 60601-1-2 - Medical Electrical Equipment - Part 1:
General Requirements for Safety - 2. Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
• IEC 60601-2-22:2007 - Medical Electrical Equipment - Part
2: Particular Requirements for the Safety of Diagnostic and
Therapeutic Laser Equipment
• IEC 60825-1 - Safety of Laser Products - Part 1: Equipment
Classification, Requirements and User’s Guide
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