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Does your company manufacture or market medical devices in the European Union? Then you’re probably aware of the upcoming implementation of the EU Medical Device Regulations in May of 2020. And for IVD manufacturers, the new In Vitro Diagnostics Regulation goes into effect May of 2022. But whether you have four months or two years to prepare, you must be educated on the new regulations, which will modernize the processes by which medical devices and IVDs come to market.

On January 22, 2020, Audi, Qualcomm, and the Virginia Department of Transportation announced the deployment of a new C-V2X (Cellular Vehicle to Everything) in Northern Virginia. According to the announcement, this deployment will include warnings that alert cars to work zones as well as signal phase and timing (SPaT) to provide cars with a countdown from red to green lights. 

Chairman Ajit Pai favorably on this announcement, stating that this technology is promising, as it enables communication between cars, infrastructure, pedestrians, cyclists, and road workers. Additionally, he commented on a proposal to designate a portion of the 5.9 GHz band to this technology, stating: 

 

"Today’s C-V2X deployment announcement was only made possible through an experimental license. That’s because the current rules governing the 5.9 GHz band lock us into DSRC, a technology authorized by the FCC more than twenty years ago that has never been widely deployed. The FCC recognizes the promise of C-V2X, having voted unanimously in December on a proposal to designate 20 megahertz for its deployment in the 5.9 GHz band. If this proposal is adopted, it would be a significant step forward for automotive safety, since there is currently no spectrum designated for C-V2X. Americans on the move would be the beneficiaries—but only if the FCC takes action and leaves the failed status quo behind." 

 

C-V2X is divided into four separate communications categories: 

 

  • V2V Communication: supports safety systems with collision-avoidance capabilities 
  • V2I Communication: controls emissions, reduces congestion, and aids in other safety-related applications
  • V2P Communication: allows cars to see other people and send alerts to drivers and pedestrians via smartphone applications 
  • V2C Communication: supports cloud-based security, information, and entertainment.   

 

C-V2X is a step forward in the world of IoT, where all devices are connected, operations are more efficient, and people's safety is more effectively handled.  

On January 22, 2020, the FCC issued a Notice of Proposed Rulemaking: 。 

This notice proposes the removal of existing non-federal secondary radiolocation and amateur allocations in the 3。1 - 3。55 GHz band。 In addition, it proposes the relocation of incumbent non-federal operations out of the band。 This proposed rule would eliminate the non-federal radio location services and non-federal amateur allocations in the band。 

This NPRM seeks comment on appropriate relocation options, the process of relocation, the transition mechanism for relocation, and potential costs。 Comments are due by February 21; reply comments are due by March 23。 

DoD Announces EMS Superiority Strategy

Posted on January 22nd 2020

The Department of Defense has recently announced that a new electromagnetic spectrum (EMS) strategy—the EMS Superiority Strategy—will be released this summer. This comes following discussions in the fall and winter of 2019 regarding the United States’ EMS vulnerabilities.

ISED Releases RSS-310, Issue 5

Posted on January 14th 2020

 

On January 9, 2020, ISED released , which supersedes the 4th issue. Following are the updates:

 

  • The requirements for devices operating in the 24 – 24.25 GHz band were removed. These devices are now required to be certified under .
  • The resource regarding electronic labelling of equipment has been removed and can be found in .
  • The requirements for Category II receivers have been removed and can be found in.
  • The exemption from any requirement for infrared wireless devices has been removed.
  • The requirements for AC wire carrier current devices have been revised.

 

Notes:

 

You can refer to for the text needed for user manuals.

ISED Seeks Comment on RSS-192, Issue 4

Posted on January 7th 2020

 

On December 20, 2019, ISED released a draft consultation of RSS-192, Issue 4, "Flexible Use Broadband Equipment Operating in the Band 3450-3650 MHz。" This standard delineates the requirements for equipment certification of flexible use equipment used in fixed and/or mobile services operating in the 3450-3650 MHz band。  are due by March 6, 2020。

A transition period of six months will be given following publication. Within these six months, certification under Issue 4 or Issue 3 will be accepted. All equipment covered by this standard is classified as Category I Equipment and is subject to licensing under subsection 4(1) of the Radiocommunication Act. You can view RSS-192, Issue 4 here. 

 

On November 26, 2019, the FCC released a designating Chinese telecommunications manufacturers Huawei and ZTE as covered companies, or those who pose a risk to the national security of the United States. Following the Report and Order, U.S. operators were to remove and replace any existing equipment from these companies and were prohibited from purchasing, obtaining, maintaining, improving, modifying, or otherwise supporting any equipment or services from these companies. Huawei, claiming the FCC did not provide any evidence of its risk to the U.S., has challenged the FCC in court. The FCC is now  on whether Huawei should be designated as a covered company. Comments are due by February 3, 2020.   

According to the FCC, Huawei poses a security risk to the U.S. because "Chinese intelligence agencies have opportunities to tamper with their products in both the design and manufacturing processes." Huawei also offers services managing telecommunications equipment, which the FCC believes could be a front used to give operators access to large amounts of U.S. user data for malicious purposes. Huawei argues that the U.S. is not subject to Chinese security laws, but the FCC has cited Huawei's obligation under Chinese law to "assist with Chinese intelligence-gathering" as evidence that Huawei is required to—and could—fulfill Chinese government objectives. Huawei denies all allegations and claims the FCC lacks the authority to prohibit the use or sale of its equipment. 

 

 

In August of 2019, the Chicago Tribune published an article entitled “,” an article that sparked a wild debate between the proponents and critics of the FCC’s current RF exposure limits for cell phones. Why? Because the Chicago Tribune reported that various cell phone models tested in their experiment emitted RF levels far above the FCC’s limits.

When it comes to product design, there are many more considerations required than the way the product looks and functions. Engineers must consider electromagnetic interference, both to and from other devices; conformity to applicable standards; cost-effectiveness; and, of course, product safety. According to the United States Department of Labor, most electrical accidents are caused by unsafe equipment, installation, environment, and work practices. Workers and consumers often suffer from electric shock, exposure to arc-flash and arc-blast, and exposure to excessive light and sound energies. The last thing any product manufacturer or designer wants (or needs) is a legal battle between himself and an injured consumer—and, thankfully, most electrical injuries can be avoided. Yet, often, product designers fail to consider a product’s electrical dangers during the design process, and this is the most critical moment to consider such thoughts.

Assuming that a product is electrically safe for consumers to use is irresponsible and dangerous, and waiting until product testing to learn if your product is safe is simply a waste of time。 As with EMC testing, electrical safety testing can be cumbersome if your product fails。 Rather than waiting to see if your product passes electrical safety testing, engineers should consider electrical safety during the design cycle to reduce the amount of time and money spent as well as the chance of consumer injury。 Here, we’ll discuss our top tips on how to design for electrical safety。

ISED Publishes CPC-2-1-28, Issue 2

Posted on December 27th 2019

This month, ISED published CPC-2-1-28, Issue 2, , which supersedes Issue 1, Voluntary Licensing of Licence-Exempt Low-Power Radio Apparatus in the TV Bands (2015). 

In March of 2019, ISED released SMSE-003-19, , in order to update the regulatory framework regarding wireless microphones. Additional spectrum for wireless microphone use and new licensing eligibility requirements were presented, and as a result, the moratorium on licensing of wireless microphones was lifted in the TV broadcasting bands (54-72 MHz76-88 MHz174-216 MHz, and 470-608 MHz) as well as a portion of the 600 MHz band, specifically from 657-663 MHz.

Under this new issue, the following frequency bands for use by wireless microphones and the maximum bandwidth and power allowed for the operation of these devices are certified under RSS-210:

 

Table 1: Frequency bands for wireless microphones certified under RSS-210
Frequency band
(MHz)
Transmit e.i.r.p.
(mW)
Maximum bandwidth
(kHz)
VHF TV Band
54-72, 76-88, 174-216
50 200
UHF TV Band
470-608
250 200
600 MHz Band
614-616, 653-663
20 200

Table courtesy of ISED

 

You can view for more information。 

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