by Anne Vogel
Regulatory Affairs Manager (Brain Products)
As manufacturer of hardware products for neurophysiological research, Brain Products confirms “that we fulfil due to design, choice of material/components and production procedures the requirements of the RoHS Directive“. If your purchasing department ever asked for this kind of certificate, let me explain you what it is.
Already back in February 2003, the European Union (EU) adopted the “Restriction of Hazardous Substances Directive 2002/95/EC (RoHS-I)”. RoHS-I took effect on July 1, 2006 and since then constitutes the law in each EU member state.
What is RoHS?
Spelled out in full, RoHS stands for “Directive on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment” and this is already more telling. RoHS restricts the use of the following 6 substances in the design and manufacture of various electrical and electronic equipment:
- Lead (Pb)
- Mercury (Hg)
- Cadmium (Cd)
- Hexavalent chromium (Cr6+)
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ether (PBDE)
Are Brain Products BrainAmp amplifiers, electrode caps, accessories, etc.
affected by RoHS?
Under RoHS-I, medical devices were exempted from the requirements as listed above. However, on July 22, 2014 RoHS-II (i.e. Directive 2011/65/EU) came into effect, and since then the above requirements have become applicable to medical devices as well.
- Affected by RoHS are or will be
01. Large household appliances
02. Small household appliances
03. IT and telecommunications equipment
04. Consumer equipment
05. Lighting equipment
06. Electrical and electronic tools
07. Toys, leisure and sports equipment
08. Medical devices as of July 22, 2014
09. Monitoring and control instruments including industrial monitoring and control instruments
10. Automatic dispensers
11. Other EEE not covered by any of the categories above (‘catch-all category’) as of July 22, 2019
Brain Products sells medical devices. Therefore, RoHS-II compliance is required, isn’t it?
Let’s answer this step by step:
- With effect from October 7, 2014 all of our products were declared non-medical devices. Beyond this date, RoHS-II compliance does not need to be confirmed.
- Products (e.g. BrainAmp amplifiers and accessories) that were sold as new medical devices from July 22, 2014 to October 6, 2014 are subject to an official RoHS-II compliance declaration by the manufacturer.
- RoHS-II compliance for electronic products as has been specified in the above section “Other EEE not covered by any of the categories above (‘catch-all category’)” will have to be confirmed by issuing an official RoHS conformity declaration with effect from July 22, 2019. This will take effect on all products manufactured by Brain Products (e.g. actiCAP active electrodes, actiCHamp etc.).
Please be reassured that we “fulfil due to design, choice of material/components and production procedures the requirements of the RoHS-II Directive. The essential components have been replaced by RoHS-II compliant ones.The features of our products have not been changed.”
If you would like to request a RoHS-II conformity declaration for any BrainAmp amplifier that was purchased as new medical device (July 22, 2014 to October 6, 2014), please contact email@example.com and indicate the serial number of your BrainAmp amplifier.
©Brain Products GmbH 2014