Compliance
Certified quality. Made in Germany.
Each row names the certificate itself, the standard at its publisher and, where an issuing body exists, the way to verify it there. So you do not have to take our word for it: take the certificate number and look it up at TÜV SÜD or UL.
Our quality management system is certified by TÜV SÜD Management Service GmbH. The scope covers in-house and contract development, production, distribution and service in the field of mechatronics and optoelectronics.
Quality management for medical devices, certified by TÜV SÜD Product Service GmbH. The scope covers design and development, production and distribution of galvanic isolation devices for electrical signals and power in medical technology.
International safety standard for medical electrical equipment. For IEC 60601-1 there is no body that issues us a certificate: the IEC publishes the standard, and we declare conformity under our sole responsibility. The verifiable document is therefore our CE declaration of conformity. For the EMOSAFE network isolators it names IEC 60601-1:2005 + A1:2012 + A2:2020 (Ed. 3.2) and IEC 60601-1-2:2015.
Restriction of the use of certain hazardous substances in electrical and electronic equipment. RoHS is not certified but declared by the manufacturer. Our CE declarations of conformity name Directive 2011/65/EU (RoHS II) together with delegated Directive 2015/863/EU (RoHS III), product family by product family.
The EMOSAFE network isolators are recognized by Underwriters Laboratories as a Recognized Component for the USA (UL) and for Canada (cUL). That recognition applies to components built into an end device, it is not a standalone UL listing. Testing was carried out against AAMI ES60601-1 and CAN/CSA-C22.2 No. 60601-1.
This is the document that gets asked for when it matters. In it we declare, under our sole responsibility, which directives and standards a product meets, one declaration per product family.