EMCI Completes CBTL Audit
Manufacturers of medical products will be pleased to hear that EMCI completed its initial CBTL audit on March 4th, and we anticipate receiving our CBTL certificate within 4 to 8 weeks, making EMCI one of the few CB Testing Laboratories (CBTLs) for EMC in the United States. EMCI has long been a leader of EMC testing for medical products for CE, FDA and JFDA compliance. Becoming a CBTL opens EMCI up to the prospect of doing CB Scheme testing for medical products for world-wide compliance, as our scope includes 2nd, 3rd and 4th editions of IEC 60601-1-2.
The CB Scheme is an internationally accepted approach to compliance for electrical and electronic equipment. It is operated by the IEC System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE). While it is well-established for product safety, the EMC part of the CB Scheme is only recently gaining traction, particularly for medical equipment. The concept is that a product can be tested once, and the CB reports (one for EMC and one for product safety) will allow sale of the product into any CB member country, provided all the national deviations are observed.
4th Edition of IEC 60601-1-2 Published
In February of this year, IEC 60601-1-2, 4th Edition (2014-02) was published. Although this document has yet to be harmonized (i.e., recognized by the EU as an EN document), it is anticipated that when this happens, the new requirements will become effective sometime in 2017. While the emission standards remain essentially unchanged, there have been some dramatic changes made to the immunity requirements.
Two areas which will impact most designs are electrostatic discharge and radiated RF immunity. Both requirements now have significantly higher test levels. For RF immunity, higher levels are coupled with new modulation schemes which could make compliance for analog circuitry considerabley more challenging. In addition, it is possible that ESD may now be applied to connector pins on patient-connected ports. In the event this testing is applicable, the test level would be +/-15 kV! Not only does this break new ground for commercial ESD testing, it does so at what could be a very destructive test level.
EMC Integrity has the equipment to perform testing to the newer, more stringent levels. We can also craft a test matrix which will cover both 3rd and 4th editions, thus saving you time and money.
In the event of a product failure, we have the design expertise to help clients meet these requirements with manufacturable, cost-effective solutions.
Please contact EMCI for more information about how the new EMC requirements for medical devices might impact your product design.
A Trusted Leader Since 1994
Centrally located between Denver, Boulder and Ft. Collins, EMC Integrity, Inc. has been serving the EMC community since 1994. In 2006, EMCI relocated to a new state-of-the-art, custom facility where we are able to offer full-compliance emissions and immunity test services under one roof. Choose EMC Integrity, Inc. for all your emissions and immunity testing needs. We offer:
- A Cost-Effective Solution. Our two fully-accredited 10-meter chambers provide fast, accurate emissions testing, as well as an excellent environment for clients to trouble-shoot their emission problems.
- Advanced Testing Equipment. Our complete and accredited emissions and immunity lab performs all the necessary testing required for FCC, IC, CE, C-tick, VCCI, BSMI, MSIP, and MIC.
- World-Wide Access. EMCI has passed out CBTL audit and are currently awaiting our CBTL certificate. Once we have received this, we will be able to perform CBTL testing for EMC for medical products to IEC 60601-1-2, 2nd, 3rd and 4th editions. Also, as a Nemko partner lab, EMCI can help clients obtain legitimate and legal product certification for nearly any country in the world.
- Industry Know-How. The EMCI MIL-STD/Aerospace lab has been independently audited by several major corporations and is approved to test components which have been used in C-17 aircraft, the space shuttle, the international space station, and more.
- Leading-Edge Expertise. Clients benefit from our thorough understanding of both domestic and international standards, which helps us optimize test matrices for their products.
- A Convenient Location. Our lab is based in Longmont, Colorado on the eastern slope of the Rocky Mountains. It's easily accessible to all of our clients, including those flying into Denver International Airport (DIA).
Please call us at 1-888-423-6275 to arrange a tour of our facility and meet our staff. We look forward to working with you.
EMCI Expands Capability to Intentional Transmitters
EMC Integrity is pleased to announce that it is finally official: we're now testing intentional transmitters. Our in-house test capability includes FCC (Federal Communication Commission for the US), IC (Industry Canada for Canada) and CE testing (Conformite European for the European Union). However, EMCI also offers world-wide access through our partner-lab relationship with Nemko.
It seems nearly everyone is using the 2.4 GHz band these days, but requirements can vary depending on whether or not a product is a frequency hopping spread spectrum (FHSS) device, Bluetooth Legacy, Bluetooth Low Energy, Zigbee, etc. EMCI has direct access to decades of intentional transmitter expertise and is happy to assist and educate our clients. Contact us and we will take the time to meet with you, discuss your project requirements, give your a tour of our facilities, as we offer first-hand access to our expertise. Whether it's 2.4 GHz, 5.8 GHz, 902 to 928 MHz or a different band entirely, EMCI will be happy to assist.
EN 61326-1: 2013 Harmonized
After seven years, the harmonized standard for test, measurement and laboratory equipment has been updated. The new version is EN 61326-1: 2013. Many people who qualify their products under the generic standards aren't even aware of the existence of this standard, but EN 61326-1 is the product family standard for electrical equipment for measurement, control and laboratory use. In other words, this standard defines the EMC emissions and immunity requirements for compliance with these product types for shipment into the European Union (EU). Now that the 2013 version has been harmonized (i.e., published in the Official Journal of the EU), it will become mandatory on August 15th of 2015. The implication is that on that date, data, DoCs, etc. referencing the 2006 version will no longer be valid.
Recall that the hierarchy for EU standards is product specific, then product family and then generic. If a product specific standard exists for your product, you should test to it. If not, you should qualify your product by testing to a product family standard. If neither product specific nor product family standards exist for your product, you should qualify your product by testing to the generic standards.
For emission requirements, EN 61326-1 simply references CISPR 11/EN 55011 (the product family emissions standard for industrial, scientific and medical equipment). However, for immunity, it defines three different types of environments: basic, industrial and controlled electromagnetic. In addition, Annex A defines a limited subset of immunity requirements for portable test and measurement equipment which is battery powered. (An example of a product type covered under Annex A would be a battery-powered digital multi-meter.)
To view a white paper which summarizes the changes in this document, click here.
Thursdays at EMCI are Officially "Bodacious"!
Every Thursday, the Bodacious Eats food truck sets up in the vacant lot just west of EMCI, serving excellent hot soups, sandwiches and burgers from 11:30 am to 1:00 pm. Their delicious food is a welcome addition to Vista Commercial Center, providing convenient take out dining for EMCI employees, clients and the entire park. Their menu changes from week to week, but you can always count on great food and friendly service.