REACh and RoHs regulations

Dräger products protect, support and save lives. As a result, it is essential to meet both technical and environmental requirements worldwide. These environmental requirements often include restrictions or declaration requirements for certain substances that are defined in guidelines such as the REACh Regulation (EC) No. 1907/2006, the RoHS Directive 2011/65/EU (and RoHSII) and the Medical Devices Regulation 2017/745 (MDR), which entered into force in 2020.

It is crucial for Dräger to look beyond the currently applicable requirements and obtain further information about substances in products and their components. The Dräger Substance Radar initiative fulfils this aim.

On the following pages, you can find information about the Dräger Substance Radar, the REACH Regulation, the RoHSII Directive and the Medical Devices Regulation. We also provide further explanations about how to proceed as a supplier.

REACh and RoHs regulations

RoHS

For Dräger as a manufacturer, all products that we bring to market must be RoHS compliant. This means that all components and structural elements that are part of Dräger products must also comply with this regulation.

RoHS

TSCA

On 6th January 2021, the United States Environmental Protection Agency (US. EPA) announced a ban on the manufacture, use and distribution in commerce of 5 Persistent, Bioaccumulative and Toxic (PBT) substances including articles containing these substances. For details see under 40 CFR Part 751, Subpart E. The new rules went into effect on 8th March 2021 for four of the substances except for PIP 3:1, which has its implementation deadline extended to October 31st, 2024. For Dräger as a manufacturer, all products that we bring to market in the USA must be TSCA compliant. This means that all components and elements that are part of Dräger products must also comply with this regulation.

Substance ban under TSCA Section 6 (h)