29 Nov RoHS Directive 2011
The RoHS directive restricts hazardous substances that may be contained in Electrical and Electronic Equipment (EEE).
The new RoHS Directive 2011/65/EU, better known as RoHS 2, went into effect on January 2, 2013. But what does this mean for the Original Equipment Manufacturer (OEM)? Article 7 of the directive outlines the deliverables and actions that manufacturers must take to comply with RoHS 2. These actions include identifying and collecting the required information, determining the validity of the data and the trustworthiness of the supplier, and ensuring that the supplied information remains valid.The European Union has produced a guidance standard, EN 50581 that provides one means of compliance with the requirements in Article 7 of Directive 2011/65/EU.
RoHS 2 introduces a risk managed approach to demonstrating compliance. The OEM uses the probability that any of the product’s parts or sub-assemblies contains a restricted substance as a basis for assigning a risk level to each part or sub-assembly. In addition, the manufacturer should include a supplier credibility evaluation as part of the risk assessment. The supplier evaluation can be based on past experiences, interactions, and audits.
Using the risk assessment as a guide, the OEM collects the appropriate material and supplier declarations. Performing a thorough risk assessment can reduce the time and effort expended in the collection step since lower risk items do not require the same level of information as higher risk ones. A signed contract is considered a risk reduction against arbitrary parts substitution and should be included as collected information. If the proper declarations cannot be obtained for a part or material, the OEM may need to contract a laboratory to determine what level of hazardous substances are present, if any.
The OEM must establish a procedure and guidelines to evaluate the collected documentation and determine its validity. To demonstrate continuing compliance through the product life cycle, the manufacturer needs to verify that the collected documentation remains valid by performing periodic reviews.
The following are some links that contain helpful information about RoHS 2:
Contact a Realtime expert for help in using the EN 50581 standard, RoHS 2 in general, or navigation through the compliance pathway, including 21CFR 820, IEC 60601-1, ISO 14971, IEC 62304, IEC 62366, and numerous others.
The Realtime Group has deep Medical Product Development experience. We have a shared passion for time-to-market and product compliance. Visit us at www.TheRealtimeGroup.com or call us at 972-985-9100 to see how we can help you with your product development and testing!
Annette Bittle, Project Manager and Sr. Systems Engineer