Medical Silicon Conference Logo

What the world needs now is an ISO RoHS

The Ministry of Information Industry Order 39 went into effect March 1. It's China's RoHS (Reduction of Hazardous Substances) regulation, and like most state issued edicts, it is ambiguous, unclear, and incomplete. But get ready to memorize every bit of it if you want to sell electronic information products, as Order 39 calls them, in China.

The Order is a good news/bad news story. “The good news is that it is similar to the E.U. RoHS directives. The same six materials are targeted for reduction — lead, mercury, cadmium, and three others — and to the same levels,” says Steven Schultz, director of strategic planning at Avnet, a distributor of electronic components in Phoenix.

The bad news is that, besides being ambiguous and incomplete, the Order has no official translation. You can download a version from aeanet.org/govermentaffairs but its first line says it's unofficial. Understandably this has left a lot of companies in a quandary.

Your big question should be “Does the Order cover our medical device?” You'll find the answer in a catalog referenced by the Order, when they get around to issuing it. Article 3 however, does vaguely refer to a few covered items in generic terms. For one, it mentions specialized electronic products. So far, there are no exemptions.

It's likely that the exemptions will also be unclear. For instance, says Schultz, suppose medical devices are exempt, and one happens to rely on a separate PC for control. Is the computer exempt?

The Order also ignores the E.U. concept of self declaring. That is, by marketing products in the E.U., firms declare their wares meet RoHS regulations. Not so in China.

In fact, the Chinese government takes the opposite stance. A product listed in the forthcoming catalog must be tested by a spelled-out method and in a Chinese approved lab, according to Schultz. That means your product will be closely examined and possibly dissected before it goes on sale.

In other words, a country with difficulty protecting intellectual property wants to open your equipment for a closer look. To add to this anxiety-provoking situation, Schultz suspects too few labs will be assigned to handle the flood of products.

The flawed standard almost makes China look like it's itching for a trade war. “But I don't think you can say the Chinese are being exclusionary for wanting to do things their way,” says Schultz. An optimistic interpretation might be that the government is running hard to catch up with Western standards, and it's tripping over its effort.

But don't sit still waiting for clarifications, suggests Schultz. Electronic component suppliers can help their cause by posting RoHS required material declarations on their Web sites. “Make them readily available to anyone,” he says.

And unfortunately, other countries and even some states such as California are considering their own versions of RoHS. So what world commerce needs now is one ISO RoHS. Is that too much to ask?

Want to use this article? Click here for options!
© 2012 Penton Media Inc.


         Subscribe in NewsGator Online   Subscribe in Bloglines

Acceptable Use Policy
blog comments powered by Disqus

Back to Top

Social Media

Blog

Like us on

Follow us on

Browse Back Issues

December 2011

December 2011

November 2011

November 2011

October 2011

October 2011

Medical Design Sept. 2011 cover

September 2011

July/August 2011

July/August 2011

June 2011

June 2011

May 2011

May 2011

Medical Edge Newsletters

View Sample Newsletters