Most products are listed by ETL testing laboratories as being in compliance with the requirements of UL 61010-1: “Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use; Part 1: General Requirements”. The “US” in the lower right of the ETL mark demonstrates this listing.
Most products are listed by ETL testing laboratories as being in compliance with the requirements of CAN/CSA C22.2 No. 61010-1: “Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use; Part 1: General Requirements”. The “C” in the lower left of the ETL mark demonstrates this listing.
Most products meet the intent of Directive 2014/35/EU, the Low Voltage Directive. Compliance is demonstrated using one or more of the following standards:
IEC/EN 60825-1: “Safety of laser products – Part 1: Equipment classification and requirements”.
IEC/EN 61010-1: “Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 1: General Requirements”.
IEC/EN 61010-2-010: “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 2-010: Particular Requirements for Laboratory Equipment for the Heating of Materials”.
IEC/EN 61010-2-081: “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-081: Particular Requirements for Automatic and Semi-Automatic Laboratory Equipment for Analysis and Other Purposes”.
IEC/EN 61010-2-101: “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment”.
Most products meet the intent of Directive 2014/30/EU for Electromagnetic Compatibility using EN 61326: “Electrical Equipment for Measurement, Control, and Laboratory Use”.
Most products comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
The device may not cause harmful interference, and
The device must accept any interference received, including interference that may cause undesired operation.
Most products are Class A or B digital apparatus and comply with Canadian ICES-003.
Available upon request for some products.
Some products, along with the calibrators and controls manufactured by Advanced Instruments, are listed with a U.S. Department of Health and Human Services, Food and Drug Administration. Consult product literature or contact Advanced Instruments, Inc. for further information.
Some products, along with the calibrators and controls manufactured by Advanced Instruments, are licensed with Health Canada, Therapeutic Products Directorate, Medical Devices Bureau. Consult product literature or contact Advanced Instruments, Inc. for further information.
Some products meet the intent of Directive 98/79/EC for In Vitro Diagnostic Medical Devices. The Authorized Representative for Advanced Instruments IVD products in the EU is:
Winckels Medical Devices Expertise (WMDE), Bergerweg 18, 6085 AT Horn, The Netherlands
Most products meet the intent of Directive 2002/96/EC as amended by 2003/108/EC for Waste Electrical and Electronic Equipment. New products introduced in 2015 do meet the intent of the directive 2012/19/EU on “Waste Electrical and Electronic Equipment, (recast).
Most products meet the intent of Directive 2002/95/EC for “Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment”. Most products carry one of the following exemptions per 2002/96/EC:
New products introduced starting in 2012 will meet the intent of directive 2011/65/EU for “Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, (recast)”.
Some products may contain a non-rechargeable lithium battery as part of an integral memory backup NVRAM component.
Most products meet the intent of Directive 2006/66/EC as amended. Pursuant to CFR49 and IATA Dangerous Goods Regulation, UN/ID# 3091, special provisions A45 and A48, there is a threshold value (quantity) of 1.0 gram Li, per unit of product. Our products contain a maximum of 0.29 gram Li, and therefore conform to the provisions of this regulation.
These products are not restricted from air transport due to these, or any other, international regulations known at this time.
Our Artel Laboratory at 25 Bradley Dr, Westbrook, ME is an independent entity that adheres to a more stringent quality standard. The Laboratory’s quality policies are a commitment to good laboratory practice and to the highest quality of service for our testing and calibration activities.
The Artel Laboratory is accredited by A2LA (American Association for Laboratory Accreditation) to ISO 17025, for technical competence in the field of Calibration (Certificate 2093-03).
