July 15 2010
As of April 1, 2010 Korean officials have tightened importation requirements. Now, a manufacturer must provide a KCC certificate and two photos of the product (front and label) in order to get customs clearance. Every shipment to Korea must contain these documents.
Northwest EMC can help you obtain a KCC certificate. Our U.S. laboratories are accredited to the Korean KN standards and our in-country agents make obtaining approvals fast and easy. Typically, KCC certificates are received within 5 business days after submission to Korea.
May 21 2009
On March 20, 2009 the FCC adopted rules for the creation of the Medical Device Radiocommunication Service (MedRadio). (ET Docket No. 06-135). MedRadio will replace the existing Medical Implant Communications Service (MICS) formed in 1999. It remains under Part 95I and maintains most of the technical rules of the MICS service. MedRadio keeps the spectrum previously allocated for MICS (402-405 MHz), but adds additional adjacent spectrum (401-402 MHz and 405-406 MHz).
MedRadio is based upon the existing MICS rules. It includes modified spectrum sharing requirements in the new wing bands (401-402 MHz and 405-406 MHz). Implants that are LBT-enabled can be used across the entire 401-406 MHz band. Body-worn devices that are LBT-enabled will be, with one exception, permitted to operate only in the new wing bands at 401-402 MHz and 405-406 MHz. Temporary body-worn transmitters can be used in the 402-405 MHz core band solely during a limited patient evaluation period in order to determine the suitability of a fully implanted device, provided that they fully comply with all other MedRadio rules applicable to the band.
Both implant and body-worn transmitters using non-LBT spectrum access methods (with reduced EIRP and duty cycle limits) will also be permitted in the new wing bands. In the core band, non-LBT operation will be limited to medical implant devices operating with a total channel emission bandwidth not exceeding 300 kilohertz centered at 403.65 MHz. The rules are generally harmonized with EU standards and other international requirements.
The FCC encourages the continuing use of the legacy MICS core band predominantly for life-critical applications, such as pacemakers and defibrillators. MedRadio is not a legal requirement until 90 days after publication in the Federal Register.
February 19 2009
Amendment A1:2007 to EN 55022:2006 (CISPR 22:2005/A1:2005) will be mandatory starting Oct 1, 2010. This amendment requires testing radiated emissions above 1 GHz
Also note that VCCI will require radiated emissions testing above 1 GHz starting April 1, 2010 using the same CISPR test methods and spec limits.
For new and existing products that are shipped into Europe after Sept 30, 2010, compliance to the new requirements found in A1:2007 is mandatory; otherwise customs could prevent entry into the EU. So for any of your current or future products that you plan to ship to Europe after Sept 30, 2010, you should test to the new standard and update your DoCs.
Northwest EMC is equipped with the laboratory equipment and chambers required to perform theses measurements.
Please feel free to contact us for more information: Alee Langford, Customer Service Manager. Phone Number:503-943-3122 or email at alangford@nwemc.com.
May 31 2007
Amendment A2:2005 to EN 61000-3-2:2000 will be mandatory on January 1, 2008. This requires measurements in compliance with the latest version of EN 61000-4-7. Unfortunately, the test equipment presently meeting the older versions of the standard will not meet the new requirements.
As part of our commitment to continuous improvement, we have purchased new flicker and harmonics test equipment for all of our test labs. Our brand new Voltech PM6000 units are capable of testing to the new Standards.
In order to remain in compliance, all units previously tested for harmonics that are to remain on the market will need to be re-tested by the end of 2007. Please call us at 888-364-2378 to schedule a test or determine if your units require additional testing.
NORTHWEST EMC - (888) 364-2378 - EMC & EMI Testing - Located in Oregon, Washington, Minnesota and California.
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