Environmental Design Standards and Regulations
Reference
Directive 2012/19/EU
Directive 2011/65/EU
SJ/T 11364-2014
Serious Incidents
Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and
the relevant regulatory authority in which the user and/or the patient is established.
Sensititre AIM™ Instructions for Use
Description
European Union "WEEE Directive"— Waste electrical and
electronic equipment
European Union "RoHS Directive"— Restriction of hazardous
substances in electrical and electronic equipment
Marking for the Restricted Use of Hazardous Substances in
Electronic and Electrical Products (for items shipped to the
People's Republic of China). For instrument specific
certificates, visit www.thermofisher.com/us/en/home/technical-
resources/rohs-certificates.html.
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