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An Insider Blog from Leaders on EMC & Radar Engineering


On January 18, 2015, Saudi Arabia's Food & Drug Authority, SFDA, issued a guidance document on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).
 
The new guidance mainly clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation.  The key points are as follows:
  • In cases where dual-language labeling is not available or possible for lay-use devices, labeling should be provided  in Arabic
  • Electronic labeling is allowed for devices intended for professional use, but labeling for lay-use devices must be provided in paper format
  • Labeling information must include country of origin
  • A device’s SFDA Medical Device National Listing Number may be included on its label, but its inclusion is optional; no other SFDA numbers should be on the device label

Recently, Taiwan's National Communication Commission (NCC) opened 5150 - 5250 MHz for use by wireless communication equipment. Equipment operating in this band may be tested and certified for use in Taiwan, but the official Taiwan technical standard (LP0002) has not been formally published to include 5150 - 5250 MHz. Until the formal publication, NCC stated that test rules for the new band will follow FCC Part 15E.
To find out more, please contact Rhein Tech Laboratories, Inc at sales @ rheintech.com

EU - Wireless Approvals Workshop

Posted on February 19th 2015 by

American Certificate Body, ACB, is providing 4 workshops in the EU covering a comprehensive overview of compliance, testing, methods and requirements for EMC and Radio Regulations.  The workshops will cover methods of evaluation and certification requirements for equipment with demands for EMC and radio compliance, with specific focus on radio regulation compliance as follows:

  • Understand the approvals routes available in each region and you best solutions
  • The latest FCC, Industry Canada and Japanese MIC Rules and Regulations
  • Understand the requirements of the European Radio Equipment Directive
  • Understand the test requirements and applicability of test results
  • Learn about testing and reporting for the purpose of regulatory compliance
  • Discuss projects and compliance issues in a dynamic workshop environment
  • Interact and exchange with your colleagues in the industry
  • Hear from the experts on compliance processes and interpretations
  • Modular Approvals and the integration of modules into host equipment

In addition, the following important topics will be new to this year's training: 

  • The new changes to the FCC rules which affect manufacturers, test labs and TCBs
  • The new 5 GHz WLAN rules for the FCC recently introduced
  • The new certification process for Canada and the new administrative requirements
  • The changes, impact and transition process for the new Radio Equipment Directive
  • Japanese Radio and Telecommunication requirements for WLAN devices

Link

India's BIS (Bureau of Indian Standards) recently announced its decision to extend the validity period for grant of registration under its Compulsory Registration Scheme to two years, effecitve immediatly.  Also, the validity period of registration granted earlier for one year has now been amended to two years, instead of the notified one year in the letter for grant of registration. 

Please contact Rhein Tech if you have any questions or testing requirements. 703.689.0368

On December 17, 2014 the FCC adopted Report and Order (FCC 14-208) as part of an ongoing review and update of the FCC's radiofrequency (RF) equipment authorization program.  The OET Laboratory is in the process of implementing the Order and as a result of the changes, several KDB Publications will  be updated.  Just recently, the FCC published Summary of Key Changes in the Report and Order FCC 14-208.  

Please contact Rhein Tech Laboratories, Inc. for any questions and/or testing requirements. 703. 689. 0368 or email sales @ rheintech.com.

The European Commission will be adding four additional substances to the EU RoHS Directive (2011/65/EU). Four phthalate substances will be added to the RoHS substance restrictions. Phthalates are primarily used as plasticizers in plastics, particularly in PVC plastic which is commonly used for wires and cables but can also be found on some electronic components or other plastic parts. The restrictions take effect beginning on July 22, 2019 and most products will need to comply including medical devices, by July 22, 2021. 

On February 5, 2014, Industry Canada posted on its website the release of the following new documents are related to TV white space devices (WSDs) and white space databases (WSDBs):

The following new and revised documents have been developed and updated respectively, to reflect recent equipment certification requirements and licensing authorization changes regarding low-power radio apparatus (LPA), including wireless microphones and wireless cameras in the TV bands:

As this document introduces changes to existing processes, CPC‑2‑1‑11 will be provisional for six months, to allow Industry Canada to gather feedback from applicants on any necessary clarifications or improvements to the document.

  • Client Procedures Circular CPC‑2‑1‑28, Issue 1, Voluntary Licensing of Licence-Exempt Low-Power Radio Apparatus in the TV Bands, which describes the procedures and processes to be followed by the public when dealing with Industry Canada. All TV‑band low‑power wireless microphone operators should note that this new CPC‑2‑1‑28 applies to all TV‑band wireless microphones operating in the frequency bands 54- 60 MHz, 76-88 MHz, 174-216 MHz, 470-608 MHz and 614-698 MHz. CPC‑2‑1‑28 also sets out the operational requirements for TV‑band LPA (i.e. wireless microphones and cameras), including licence conditions for voluntarily licensed LPA, licensing of TV‑band LPA, and licensing and registration of roaming electronic news gathering (ENG) LPA systems.

For additional information or testing requirements, please contact Rhein Tech Laboratories, Inc. at 703. 689. 0368.

On January 15, 2015, the FCC published DA 15-61 to remind nationwide wireless service providers of their obligation to release information regarding consumer signal boosters by March 2, 2015.  For each listed Consumer Signal Booster FCC ID, wireless providers should publicly indicate whether they:

  1. consent to use of the device
  2. do not consent to use of the device; or
  3. are still considering whether or not they will consent to the use of the device.

Please contact Rhein Tech if you have additional questions or testing requirements. 703.689.0368

 

On February 5, 2015, the FCC released a Notice of Proposed Rulemaking and Reconsideration Order to authorize radar applications in the 76-81 GHz band. The FCC seeks to adopt service rules that will allow for the deployment of the various radar applications in this band, both within and outside the U.S.
In the Notice, the FCC proposed rules that will accommodate the commercial development and use of various radar technologies in the 76-81 GHz band under Part 95 of FCC Rules. The proposal includes allocation changes to the bands as well as provisions to ensure that new and incumbent operations can share the available frequencies in the band. Specifically, the FCC is seeking comment on the following 76-81 GHz band matters:

  • Expanding radar operations in the 76-81 GHz band;
  • Modifying the Table of Frequency Allocations to provide an allocation for the radiolocation service in the 77.5-78 GHz band;
  • Authorizing the expanded radar operations on a licensed basis under Part 95;
  • Shifting vehicular and other users away from the existing Part 15 unlicensed operating model; and
  • Evaluating the compatibility of incumbent operations, including that of amateur radio, with radar applications in the 77-81 GHz band.

Please contact Rhein Tech Laboratories, Inc. for any questions and/or testing requirements. 703. 689. 0368 or email sales @ rheintech.com.

Japan's Ministry of Internal Affairs and Communications (MIC) is organizing the International Workshop on Mutual Recognition Agreements (MRA) for telecommunications equipment March 4-5, 2015 in Tokyo, Japan.  This workshop is designed to promote efficient utilization of the MRA and to nurture the development of internationally respected conformity assessment bodies (CABs). The workshop program includes presentations and information exchange on updated certification systems and technical regulations for telecommunications equipment.

Participants should submit their registration form no later than 2/25/2015.  Link 

During December 2014, the R&TTE Compliance Association issued TGN 20, Version 1.0 (Technical Guidance Note for SAR Testing and Assessment Guidance) with the following guidance:

  • Guidance to manufacturers as to how their device could be assessed for SAR
  • Guidance to test labs on testing devices which require a SAR assessment
  • Guidance to Notified Body assessors on how the SAR standards may be applied to sufficiently meet the requirements of Article 3.1(a) of Directive 1999/5/EC and encourage a consistent level of assessment and requirements between Notified Bodies.    

Specifically, TGN 20 addresses the following topics:

  • Test configuration and set-up
  • Channels for testing
  • Modulation for testing
  • Modes of operation for testing
  • Output power for testing
  • Test distance
  • Bystander SAR
  • Multiple transmitters

Link to TGN 20

On December 29, 2014, Taiwan's National Communications Commission (NCC) released
Compliance Approval Regulations of Telecommunications Terminal Equipment and Compliance Approval Regulations on Controlled Telecommunications Radio-Frequency Devices. Article 10 was amended in the TTE regulation and Article 8 in the RF regulations - both amendments had slight modifications to the application requirements.
To find out more, please contact Rhein Tech Laboratories, Inc at sales @ rheintech.com

The Telecommunications Certification Body Council (TCBC) will host its April 2015 Basic Training and Workshop from April 13-16, 2015 at the Holiday Inn - Inner Harbor in Baltimore, Maryland.  The April 2015 Events will be as follows:

  • April 13, 2015 - Basic Training, geared towards entry level foundation for TCB & Certification processes
  • April 14-16, 2015 - regular 3-day Workshop

As of January 1, 2015, Congo's Agence de Regulation des Postes et des Communications Electroniques (ARPCE) requires for one sample be submitted along with each Type Approval application. In some cases, a waiver may be requested if there is a size constraint/restriction in transporting the sample.   Previously, the Type Approval process for Congo was a paperwork effort only (with appropriate test reports to EU standards) and no samples were required.

Please contact Rhein Tech directly if you have any questions or need international type approval support.  703 689 0368

FCC - Amendment to Rules

Posted on January 2nd 2015 by

On December 30, 2014, the FCC released Report and Order FCC 14-208, Amendment of Parts 0, 1, 2, and 15 of the Commission's Rules regarding Authorization of Radiofrequency Equipment and Amendment of Part 68 regarding Approval of Terminal Equipment by Telecommunications Certification Bodies.   In this Report and Order, the FCC updated it's radiofrequency (RF) equipment authorization program to build on the success realized by Telecommunications Certification Bodies (TCBs).  The FCC adopted additional rules to facilitate the rapid introduction of new and innovative products to the market while ensuring that these products do not cause harmful interference to each other or to other communications devices and services. In this Report and Order, the FCC: 

  • Discontinued FCC acceptance of applications for equipment Certification of RF equipment and instead permit TCBs to process and grant all applications for Certification;
  • Codified a pre-grant approval procedure that TCBs must currently follow when certifyingequipment based on new technology that requires consultation with the FCC;
  • Clarifired a TCB's responsibilities in performing post-market surveillance of products it has approved;
  • Specified steps for addressing instances of deficient TCB performance, including appropriate sanctions for deficiencies that do not warrant rescinding a TCB's authority to issue a grant of Certification;
  • Modified the rules to reference new standards used to accredit TCBs that approve RF equipment under Part 2 of the FCC's rules and terminal equipment under Part 68 of the FCC's rules;
  • Required accreditation of all laboratories that test equipment subject to any of the certification procedures under Part 2 of the FCCn's rules and codify a procedure through which the FCC currently recognizes new laboratory accreditation bodies;
  • Updated references to industry measurement procedures in the FCC's rules; and provided greater flexibility under the Office of Engineering and Technology's (OET) existing delegated authority to enable it to address minor technical issues that may be raised when updating to the latest versions of industry standards that are referenced in Parts 2, 5, 15, and 18 of FCC's rules.  Link to Report and Order

Please contact Rhein Tech Laboratories, Inc. for any questions and/or testing requirements. 703. 689. 0368 or email sales @ rheintech.com.

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