The European Commission Has Finally Issued New Guidance For The EMC Directive (2014/30/EU)

Follow this link direct to the new guidance document, or simply click below;

https://ec.europa.eu/docsroom/documents/28323

Company Fined for Omissions in Product Manuals

In light of the state of the economy, regulatory agencies seem to be stepping up their activities. Some argue they are using this as a method to generate revenue to make up for government cutbacks.  We are definitely starting to see more fines being levied.........

http://www.incompliancemag.com/index.php?option=com_content&view=article&id=841:company-fined-for-omissions-in-product-manuals-&catid=1:latest-news&Itemid=19

CCC Mark for Mixed Systems Using Products Not Subject to Compulsory Certification

One of the questions that always comes up, and is a frequent topic for discussion when dealing with CCC, is the topic of ITE peripherals as part of a larger "system". How does CCC apply to ITE peripherals imported as part of a non-CCC regulated device, such as a large medical laboratory device?

Well, the answer is - CCC is not applicable - to a degree. The importer will still need to apply for an exemption approval for the ITE devices when clearing the goods in customs. No (external to China) agency can provide exemption approval. This needs to be done by the importer when clearing customs.

This problem is exacerbated by the possible need to later send a replacement ITE device for the larger system. At that time, the device will likely not be allowed to enter since it has no CCC certification. Manufacturers and inporters have resorted to locally sourcing replacement ITE devices to circumvent this problem.

Bottom line, specifiy CCC compliance from your OEM ITE equipment provider. Yes, it may be more expensive, but it will certainly allow for a smoother process going into China.

For more on China the China CCC mark, see earlier post, Guidance on CCC Marking for China.

UL | IEC UL 61010 International Activities Blog

UL has set up a blog to discuss and provide updates on the activities surrounding the upcomming 3rd edition of the 61010 standard. Follow this link and sign up:

UL IEC UL 61010 International Activities Blog

Laser Safety Micro Course

This may by called a "micro-course", but it is anything but that.  It's a good laser introductory course that exposes you (yes, pun intended) to laser basics through labeling requirements.

Laser Safety Micro-Course
Based on the Laser-Professionals, Inc. (LPI) Free Mirco-Course

The CB Scheme and Manufacturer Compliance Test Programs

As we move ever closer to a global economy, it becomes increasingly important for manufacturers to ensure that their product compliance programs address wordwide requirements in an ever increasingly efficient manner.

One program, implemented by IECEE (IEC System for Conformity testing and Certification of Electrotechnical Equipment and Components), known as the CB Scheme, may be of primary importance to manufacturers.  The Scheme is intended to reduce obstacles to international trade which arise from having to meet different national certification or approval criteria.

However, if a manufacturer participates in some form of supervised testing program under the auspices of an NCB, there are some countries which, although they are full participants in the Scheme, have certain levels of acceptance which may be unkown to manufacturers who are fully expectant of un-impeeded entries into participating countries.  Follw the link below for a breakdown, by country, of the different levels of acceptance;

Acceptance of Manufacturer's Testing Laboratories programs under the CB Scheme

Interlocks

Part 1 - What Do Those Categories Really Mean?

Part 2 - Category 1