RoHS July 2014 Deadline: Medical Devices and Control Instruments

In 2011, the European Union issued a new directive that updates and supersedes RoHS; it has come to be known as the RoHS Recast or RoHS 2. Under the updated directive, as of July 22, 2014, RoHS restrictions will apply to Category 8, medical devices, and Category 9, monitoring and control instruments. Before we look at what those categories include specifically, here’s an overview of deadlines yet to come under the RoHS Directive.

So, what’s in Category 9, Monitoring and Control Instruments? The types of equipment that are in category 9 of the RoHS directive have a main function of monitoring or control, says Dr. Paul Goodman in Electronics Weekly, quoted here because it stands out as one of the better summaries of what to expect from Category 9. Monitoring, Goodman says, would include measurement – ergo thermometers, analytical spectrometers and digital voltmeters are all in category 9 because they monitor temperature, concentration, voltage, etc.

Monitoring and control functions are features of thermostats that monitor and control temperature and industrial process controllers that monitor and control a variety of process parameters. Other category 9 products include smoke detectors, fire alarms, traffic signals (control of traffic), X-ray imaging of luggage or electrical equipment (but not medical X-ray which is category 8), spectrum analyzers, etc. It is incorrect however, to assume that all laboratory equipment is in category 9 as these products must monitor or control as their main function. – Dr. Paul Goodman, EW

So, what’s in Category 8, Medical Devices? Medical devices were exempt in the original directive, which meant they could contain unlimited amounts of toxic metals and plastics and still be marketed as RoHS compliant. Not anymore. Medical devices are still a broad category, and note that RoHS is not targeting “in vitro diagnostic medical devices” yet in 2014.

So what is targeted? For example:  radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, nuclear medicine, laboratory equipment; other appliances for detecting, preventing, monitoring, treating or alleviating illness, injury or disability; but specifically excludes all implanted and infected products.

How are companies handling RoHS compliance? Industry’s leading companies are managing their compliance at various stages. There are challenges.

Certainly one challenge with RoHS is the many different formats suppliers use to submit their information. We asked a group of manufacturing risk assessment professionals on LinkedIn, “What form of documentation do you typically get from suppliers?” Here are the myriad answers.

Note: a good software should eliminate that challenge, for instance, by loading all information into a uniform data repository, so the resulting standardized data parameters are searchable, rational and reportable.


Patty and the Professor: What Homogeneous Means


Let’s see how Patty and Pete are doing with their Medical Device RoHS Crisis ….

Patty and Pete sat in a plane on the runway of the Manchester, NH, airport. Patty was just calming down after Jeff Sparkel  told her that Hal Lindsay had performed an analysis to show that the flagship medical device that Jeff’s factory assembled was RoHS-compliant using tin-lead solder. Corporate RoHS compliance was under her responsibility and she was panicking that ACME’s St. Paul site would miss the July 22, 2014 compliance date for medical devices. She literally drove straight to the airport after chatting with Sparkel on the phone. Fortunately, she and Pete both had a three-day suitcase in their offices for such emergencies. Rob’s mom agreed to help with her twin boys. What a blessing to have a mother-in-law like Rob’s mom.

To add to the stress, she and Pete almost missed the plane. He insisted that he needed to stop at a drug store, though he was secretive about the reason.

As the plane lifted off, Patty had to find out about this drug store mystery.

“OK, Pete. Why the drug store?” Patty asked.

“I’m afraid that, if I tell you, you’ll lecture me,” Pete said sheepishly.

“Out with it! Out with it,” Patty commanded.

“I bought Vick’s VapoRub to put under my nose when we are with Mr. Lindsay.  Ain’t no way I’m gonna’ be with that stink bomb unprepared,”  Pete responded.

Patty was going to say something but she started chuckling uncontrollably.

“You are welcome to share with me,” Pete offered.

As Patty tried to catch her breath, she just shook her head no.

They arrived at their hotel room at 10PM, after a quick, late dinner.

Fortunately, the timing of events was favorable. Lindsay had planned to give his final presentation the next day. Sparkel was actually pleased that Patty asked to attend.

Patty met Pete for breakfast at 7AM. By then she had run 5 miles, worked out with weights at the hotel gym, and showered. They arrived at Sparkel’s office at 7:45 and headed directly to the conference room where Lindsay was preparing to present. Upon seeing Patty and Pete, Hal Lindsay seemed surprised and turned a little red in the face.  Pete checked the room for ventilation.

Patty and Pete agreed to listen to Lindsay’s complete presentation without interruption.

“I know everyone here except for that guy in the back. He looks like a lawyer,” Pete whispered into Patty’s ear.

“He looks like a lawyer because he is one,” Patty responded. “He is my special guest,” she said.

Lindsay began his presentation sharply at 8AM. Patty had to admit that she was impressed with Lindsay’s experimental procedure. He had taken three of ACME’s St. Paul site’s highest-volume products and carefully performed teardown analyses. He painstakingly extracted all of the solder from the PCBs. One product weighed 10.2 kg and contained 11.2 grams of tin-lead eutectic solder. Patty checked Lindsay’s calculations. The fraction of lead in the unit was 0.042%, less than 0.1% that RoHS requires. All three products were below 0.05% by weight lead.

Lindsay then discussed his plan to analyze enough units to give the data statistical confidence. His charge would be an additional $20,000. Jeff Sparkel then asked if there were questions.

Patty raised her hand.

“Mr. Lindsay, what about RoHS’s requirement that all concentrations of substances of concern by ‘per homogeneous material?’ ” Patty asked.

Lindsay looked confused. His face turned a little red. It appeared that he didn’t understand what she was asking.

“Patty, please explain what ‘per homogeneous material’ means?” Sparkel asked.

“It means that any part of the product that could be mechanically separated must be less than 0.1% lead. As an example, a soldered joint can be cut out of a medical device with an X-Acto knife. Accordingly, the small piece of solder must be RoHS-compliant, so the solder itself must have less than 0.1% lead,” Patty explained.

“Per hemorrhoidgenous material, don’t apply to no medical devices,” Lindsay grumbled.

Both Patty and Pete had trouble not chuckling at Lindsay’s mispronunciation of “homogenous.”

“I beg to differ. Dr. Coleman’s explanation of ‘per homogenous material’ is spot on,” said Patty’s special guest.

Patty chuckled to herself when she realized that her guest thought she had a Ph.D.

“Who are you?” asked Jeff Sparkel.

“I’m Aaron Toynbee, Esq, our company’s general counsel. My department has responsibility for interpreting corporate compliance with environmental laws like RoHS.  We have studied the RoHS law extensively and the requirement for medical device compliance. Almost all of the medical devices we manufacture must meet RoHS compliance by July 22, 2014. I was alarmed when Dr. Coleman pointed out that there was some lack of understanding here about this.” Toynbee said.

After Toynbee spoke, it was agreed that the St. Paul team would work with Patty and Pete to resurrect the RoHS initiative that had been developed some time ago. Patty let out a deep sigh of relief.

Just as it appeared that the meeting was over, one of the younger engineers asked, “Are we still going to have Mr. Lindsay perform the analysis he suggested. It seems to me that there may be some benefit in getting this type of data.”

There appeared to be some murmuring of agreement. Hal Lindsay brightened, as it appeared that his proposed work might still be accepted.

Patty sat by watching this with incredulity. She remembered the Professor telling her that sometimes people will be too polite and not say what needs to be said. This was not going to be one of those times.

“You have got to be kidding me!” she shouted.  “There is no way we are going to continue any of this useless work!” she said even louder.

At this, Hal Lindsay’s  face turned beet red and he charged over to where Patty and Pete were. Out of the corner of her eye, Patty could see the Vick’s VapoRub gleaming under Pete’s nose.

Patty was now standing up and Lindsay had advanced to within five feet of her.

All of the sudden Lindsay came up to within a foot of Patty.

“It’s tree-huggers like you that that allowed this RoHS crap to happen in the first place,” he screamed into her face.

Patty was not prepared for this olfactory assault. Worse yet, some of Lindsay’s spittle ended up on her face. A natural gag reflex took over and she started having trouble breathing. Those in the meeting were horrified as they watched Patty crumble and slump to the floor.

Pete jumped up and instinctively and firmly pushed Lindsay back away from Patty. His Vick’s VapoRub doing its job. Sparkel’s  second-in-command, Jennifer Halliday, gently escorted Lindsay from the building, before any fisticuffs ensued.

Sparkel  and one of the female engineers helped Patty as she tried to get up. Within a few moments Patty was herself again. Everyone knew what happened, but when Patty said she probably should have eaten more for breakfast, everyone murmured in agreement.  Sparkel asked if just he, Patty, and Pete could wrap things up. Patty agreed, but asked to go to the ladies room first.

When she returned, Patty again reiterated that medical devices have to obey the “per homogeneous material” requirement and that the only way this was possible was to change to a lead-free solder. Patty and Pete confirmed their agreement to stay on for a few days to work with Sparkel’s team, to resurrect the plan to be RoHS-compliant by June 2014, a month early.

With two days of hard work, the plan was redeveloped, and Patty and Pete were confident the St. Paul team was on the right track. Jeff Sparkel apologized to Patty about 10 times.

Within no time Patty and Pete were back on the plane, heading home.

“Hey kiddo! You should receive hazardous duty pay for this one,” Pete teased.

“No kidding,” Patty responded.

“When you said you needed to go to the ladies room, I was a little worried,”  Pete said. “I thought maybe some permanent damage was done,” he went on.

“It was worse than that. I had to wash Lindsay’s spit off my face,” Patty groaned.

“Definitely Purple Heart material,”  Pete teased.

They both chuckled.



Dr. Ron


The New RoHS

In RoHS news, the real news is that the RoHS2 is really just RoHS.  We still hear people talking about “RoHS2” and “RoHS Recast”  — and there is simply no such thing:  there is just RoHS.  Yes, there were significant updates to the EU Directive that Restricts Hazardous Substances.  That process occurred over the past year.  Amendments to RoHS have been incorporated into RoHS itself.  So the terms “RoHS recast” and “RoHS2” have no meaning.

RoHS right now. Over the past year, the ban on heavy metals and other dangerous chemicals in electrical and electronic equipment has been extended to a much wider range of products. The changes apply to electronic products such as thermostats, medical devices and control panels.

European Member States have until the end of 2012 to transpose the new rules.  This means most will wait until the last minute (and beyond), but some will not, and to an American mind the order and timing will seem somewhat random.  Since there is no orderly way to hedge your bets here, getting to RoHS compliance in Q1 2012 or (Q2 at the latest) is the path of least risk.

The RoHS Directive will continue to ban lead, mercury, cadmium, hexavalent chromium and the flame retardants Polybrominated biphenyls (PBB) and Polybrominated diphenyl ethers (PBDE). The previous RoHS Directive covered several categories of electrical and electronic equipment including household appliances, IT and consumer equipment, but RoHS has now been extended to all electronic equipment, cables and spare parts.  Exemptions can still be granted in cases where no satisfactory alternative is available.

Updates to RoHS.

  •  A gradual extension of the rules to all electrical and electronic equipment (EEE), cables and spare parts, with a view to full compliance by 2019
  •  A review of the list of banned substances by July 2014, and periodically thereafter
  •  Clearer and more transparent rules for granting exemptions from the substance ban
  •  Improved coherence with the REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals
  •  Clarification of important definitions
  •  CE marking denoting compliance with European norms reserved for electronic products that also respect RoHS requirements

In view of the significant extension of the scope, the new Directive introduces transition periods of up to 8 years for the new products affected by the rules.

Photovoltaic panels are exempted from the new Directive in an effort to help the EU reach its objectives for renewable energy and energy efficiency.  Also included in the new RoHS is a mechanism to make it easier for the Commission to monitor compliance.

RoHS2 background. The revision was launched in 2008. Agreement between the European Parliament and the Council was reached in 2010 and the Directive was adopted in June 2011. Member States have 18 months to transpose the Directive. Until then, RoHS I continues to apply.

Detailed information can be found in the directive here.  See also the site on waste and RoHS.

RoHS is a directive, not a regulation:  A directive is about results, not process.  With RoHS for example, the required result is the restricted use of certain toxic metals in electronics manufacturing & in related disposal and waste.  A regulation, on the other hand, delineates how to get the result, a good example being the REACH regulation, which contains a detailed process for substance registration, use, and data sharing.

This blog is hesitant to recommend specific consultants for RoHS compliance.  However, some software for RoHS compliance such as Material Disclosure from Actio Corp., is worth looking at for RoHS compliance.