Path to ISO 13485:2016

Date: May 28, 2023

Analytical Components International is committed to the protection of the environment in the course of its business activities including compliance with all applicable environmental regulations. Accordingly, this declaration is to certify that all products that are manufactured by Analytical Components International and all associated packaging are fully compliant with the requirements of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment; RoHS2 Directive (2011/65/EU) and RoHS 10 (also known as RoHS3) Directive 2015/863 with no exemption. In addition, this declaration of conformity is issued under the sole responsibility of Analytical Components International. Specifically, products manufactured by Analytical Components International do not constitute Electrical or Electronic Equipment as defined by the Directive and do not contain the substances listed in the table below in concentrations greater than the listed maximum value.

Material / Substance Threshold Level
Lead (Pb) < 1000 ppm
Cadmium (Cd) < 100 ppm
Mercury (Hg) < 1000 ppm
Hexavalent Chromium (Cr6+) < 1000 ppm
Poly Brominated Biphenyls (PBB) < 1000 ppm
Poly Brominated Diphenyl ethers (PBDE) including deca-BDE < 1000 ppm
Bis (2-ethylhexyl) phthalate (DEHP) < 1000 ppm
Butyl benzyl phthalate (BBP) < 1000 ppm
Dibutyl phthalate (DBP) < 1000 ppm
Di isobutyl phthalate (DIBP) < 1000 ppm

Analytical Components International will continue to comply with and support any updates to the European Union’s Restriction on Use of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive, 2011/65/EU and 2015/863.

Date Place of Issue: 05/28/2023 /Stoughton, MA USA
Name / Title: Jon Bohlin, Senior Director, Mfg
Email: [email protected]