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RoHS Compliance for Medical Devices and Monitoring or Military Equipment

Posted by Phil Holman on Aug 4, 2016 5:11:18 PM

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Need Help Meeting Your RoHS Compliance Timeline?

If you produce any type of electronic equipment, you are impacted by the 2002 RoHS directive that seeks to eliminate the use of harmful substances used in the manufacture of electronic equipment.  Non-compliance will restrict the sale of your equipment into Europe and also into many other countries around the world that are requiring RoHS compliance.

RoHS_Compliance_for_Medical_Devices_and_Monitoring_or_Military_Equipment.jpgUnless you manufacture equipment that falls into category 8 (medical devices) or category 9 (control and monitoring equipment, or military equipment, or equipment used in military and national security use) you are already required to comply. Category 8 and 9 are required to comply in July of 2016, unless companies applied for, and were approved for, an extension for their exemption. These exemptions are also ending over the next few years, and soon all equipment will need to be compliant.

In addition to meeting the compliance dates, there is pressure on manufacturers who are exempt, due to the decreasing availability and increasing cost of non-compliant components. As the whole world has moved towards RoHS compliance, companies have discontinued making non-compliant material, or will make it with increased MOQs, higher pricing, and longer lead times. As a result, many of the exempt companies have moved towards using all RoHS content to better support their supply chain, even though their products do not technically need to be compliant.

The good news is that most of the contract manufacturers have become experts in building RoHS-compliant products and can easily help an original equipment manufacturer (OEM) meet its compliance requirements as a natural part of their engagement.

Most contractors have built a database in their MRP system that will identify whether a component is RoHS compliant, and if not, can assist in identifying a RoHS compliant equivalent. 

Three Basic Categories

There are three basic categories of components with regard to RoHS compliance:

  1. Components that are RoHS compliant by the nature of their composition, and have been certified to be compliant, and in many cases are being sold under the exact same part number. 
  1. Components that were originally deemed non-compliant due to the material used in the manufacture of the product, or the manufacturing process itself being non-compliant. Companies have adjusted their material content or changed their manufacturing processes to become compliant. In many cases, the part number was changed or there was a suffix or prefix added to the core part number to distinguish compliant material from previously non-compliant material. Most of these products are direct crosses to the old part number and can easily be specified without impacting the performance of the end products. Some create special handling requirements, such as reduced heat or other special practices to allow them to be used in the application. Many of these products used lead in the manufacturing process, requiring them to be re-engineered to eliminate the lead content. 
  1. Some components were deemed non-compliant and had to be completely re-engineered to meet RoHS compliance. In some cases, the performance of the products changed significantly for certain product applications and could not be easily used to meet the requirements. In other cases, no compliant materials are identified that will meet the performance requirements of the equipment. In these cases, manufacturers have to apply for extensions to the exemption until new technologies can be introduced that will meet the RoHS compliance requirements and still allow the equipment to operate as intended in the application. These are the manufacturers with the biggest engineering challenges and will definitely reshape the future products in that industry.

What to Do to Become Compliant

So if your company is working to become RoHS complaint, under the pressure of an expiring exemption, the easy path is to reach out to a contract manufacturer who will be able to assist you in transitioning away from non-compliant content. Many of these manufacturers have purchased RoHS-compliant testing equipment, which uses hand-held X-ray equipment that will look at the molecular structure of the material and test it against the RoHS content thresholds to determine compliance.

At Fourstar Connections, we are fully equipped to transition you away from non-compliant content. We apply our project management, manufacturing expertise, exceptional customer support, and advanced IT systems to provide customers with a comprehensive range of products and solutions—from cable assemblies to complex box build solutions. Having 30 years of experience, and offering a comprehensive portfolio of services and solutions to tackle a wide range of manufacturing needs, Fourstar partners with leading companies to problem solve, innovate, and find better ways for new product introduction (NPI), and create design for manufacturing (DFM) initiatives.

We know time may be ticking for you to get compliant. Contact us today to get the conversation started.

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Topics: RoHS compliance, RoHS compliance for medical devices, RoHS compliance for security monitoring, RoHS compliance for military equipment

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Fourstar partners with leading companies to problem solve, innovate, and find better ways for New Product Introduction (NPI) and Design for Manufacturing (DFM) initiatives.

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