Regulatory Approvals

Our products carry one or more of the following regulatory approvals. Additional approvals may be provided through one of our many distribution points. Please consult your sales contact for further information on your product of interest.

U.S. Safety

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.

Canadian Safety

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.

EU Low Voltage Directive

Most products meet the intent of Directive 2006/95/EC, the Low Voltage Directive. Compliance is demonstrated using one or more of the following standards:

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”.

EU EMC Directive

Most products meet the intent of Directive 2004/108/EC for Electromagnetic Compatibility using EN 61326: “Electrical Equipment for Measurement, Control, and Laboratory Use”.

FCC - Part 15, Subpart B, Class A or B

Most products comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

  1. The device may not cause harmful interference, and
  2. The device must accept any interference received, including interference that may cause undesired operation.

Canadian ICES-003

Most products are Class A or B digital apparatus and comply with Canadian ICES-003.

CB Report

Available upon request for some products.

U.S. FDA Listing

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.

Health Canada License

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.

EU IVD

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

EU WEEE

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).

EU RoHS

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:

  • As exempt medical device per Article 2, Paragraph 1 and per Annex 1, Category 8 of Directive 2002/96/EC.
  • As exempt Monitoring & Control Equipment per Article 2, Paragraph 1 and per Annex 1, Category 9 of Directive 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)”.

Mercury

QCount Automated Colony Counter models 510 and 530 have been registered with the Interstate Mercury Education & Reduction Clearinghouse (IMERC) due to the presence of mercury containing fluorescent lamps.

Lithium Battery Statement

Some products may contain a lithium battery as part of an integral memory backup NVRAM component.

EU Battery Directive

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.