Regulatory Certifications and Compliance

PLUX research products are intended for use in life science education and research applications with humans and not intended for diagnosis, cure, mitigation, treatment or prevention of desease.

PLUX accepts no liability for the loss or corruption of data caused when using any of our instruments. PLUX is ISO 9001 and ISO 13485 certified as a medical device manufacturer.

All products comply with the Directives 93/42/EEC and 1999/5/EC. Hub, EMG sensors, electrodes and charger are certified as constituents of a Class I medical device intended as an electromyographic (EMG) biofeedback system designed for physiotherapists, which provides real-time muscular feedback. See www.physioplux.com for more information.

PLUX research equipment satisfies the Medical Safety Test Standards affiliated with IEC60601-1 and is designated as Class I Type BF medical equipment. PLUX research equipment system satisfies the Medical Electromagnetic Compatibility (EMC) Test Standards affiliated with IEC60601- 1-2.

Charger Specifications:

Medical grade charger safety approvals and certifications: UL60601-1, CUL TO 22.2 no. 601.1-M90, INNOVA BAUART to EN60601-1, CE CLASS II, PSE to J60601-1, CB REPORT TO IEC 60601-1:2005 (3rd edition), AS/NZ to 60601-1, C-TICK to EN55011, CCC.

CE marked: tested to comply with EN61000-3-2, EN61000-3-3, EN60601-1-2 2001, INCLUDING EN61000-4-2, EN61000-4-3, EN61000-4-4, EN61000-4-5, EN61000-4-6, EN61000-4-8, EN61000-4-11. Complies to section 301 of energy independence and security act.

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