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On July 11, 2014, the FCC published 784748 D02 e labelling v01, providing guidance on FCC e-labeling.   The document explains how devices with an integrated display screen can present the required label information electronically (e-label) in lieu of a physical label or nameplate. E-labeling is applicable to all devices which have an integral (non-removable) display screen and are currently subject to certification or DoC requirements. These include devices that have an integrated display or devices that are subject to rules for software-defined radios or modular transmitters and are used in a host device that has an integrated display.  

Please contact Rhein Tech directly if you have additional questions or require testing and certification assistance.  703.689.0368

Kenya's Communications Commission of Kenya (CCK) has recently been renamed Communications Authority of Kenya. Our local agent does not anticipate any impact on the existing regulatory Type Approval process. Telecommunications equipment must be type approved in Kenya, but existing test reports may be leveraged and there are no labeling requirements in place.
Please contact Rhein Tech directly if you have additional questions or require testing and certification assistance. 703.689.0368
 
 

Medical Device Data Systems (MDDS), used to support digital health technologies, are no longer subject to FDA regulation per a new FDA guidance. Specific MDDS devices include:

  • MDDS falling under 21 CFR 880.6310
  • Medical image storage devices under 21 CFT 892.2010
  • Medical image communications devices under 21 CFR 892.2020

The FDA does not intend to enforce compliance for devices subject to the three regulations listed above in terms of registration and listing, premarket review, post-market reporting and FDA Good Manufacturing Practice quality system requirements.
The new FDA draft guidance also changes the agency's approach to regulating mobile medical apps and technologies where MDDS is concerned. Sections V-A-1 and V-B as well as Appendices B, C and D of the FDA's Mobile Medical Applications guidance have been amended to exclude MDDS, medical image storage and medical image communication devices from the scope of the agency's regulatory remit.

Please contact Rhein Tech directly if you have additional questions or require testing and certification assistance.  703.689.0368

On June 12, 2014, Argentina's Comisión Nacional de Comunicaciones (CNC), released NOTCNCANEH N° 8/2014 confirming that all devices using FHSS modulation and submitted for Type Approval before July 8, 2013 must now be retested at the time of renewal. This requirement falls under the latest technical standard - Protocolo para Equipos de Espectro Ensanchado por Salto en Frecuencia V13.1 (Protocol for Frequency Hopping Spread Spectrum devices V13.1) and also includes UHF RFID technology and all versions of Bluetooth. Devices submitted for approval after July 8, 2013 are not affected.

 

Please contact Rhein Tech directly if you have additional questions or require testing & certification assistance. 703.689.0368

On June 6, 2014, the FCC published 789033 D02 General UNII Test Procedures New Rules v01, additionnal guidance under "New Rules" for U-NII devices operating under Part 15 Subpart E.

The FCC is allowing a transition period to allow for devices to continue to be approved under the 'Old Rules' 789033 D03 Part 15 E) as follows:

  • New device will be permitted to be approved until June 1, 2015 under the 'Old Rules'.
  • Starting June 2, 2016, permissive changes will not be permitted for devices approved under the 'Old Rules', unless they meet the requirements of the 'New Rules'.
  • All devices approved partially or completely under the 'Old Rules' cannot be marketed starting June 2, 2016 unless they meet the requirements of the 'New Rules' in all the bands of operation.
  • New and permissive change applications for devices based on the 'Old Rules' must use the guidance 789033 D01 General UNII Test Procedures Old Rules; or .
  • Applications for new devices and permissive change applications for devices for approval under the 'New Rules' must apply all the appropriate test procedures for such devices as described in 789033 D02 General UNII Test Procedures, including software security requirements in KDB Publication 594280 D02 U-NII Device Security and the appropriate procedures from KDB Publication 905462.

Please contact Rhein Tech directly if you have additional questions or require testing & certification assistance.  703.689.0368

 

On June 5, 2014, the FCC published 558074 D01 DTS Meas Guidance v03r02, Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS). Changes to v03r01 to v03r02 are as follows:

  • Added a footnote to indicate that equipment operating in the 5725-5850 MHz band will no longer be certified under the §15.247 rules after July 2, 2015 but instead must apply under the revised §15.407 (U-NII) rules
  • Removed the unnecessary requirement that the number of measurement points ≥ span/RBW from 11.3.
  • Removed the procedures for performing integrated peak power measurements (9.1.2 and 13.3.1) because they do not produce accurate and repeatable results when applied to a random variable such as the peak power of a noise-like (i.e., digitally-modulated) signal.
  • Clarified the "Band Edge" measurement guidance provided in 13.0 to reflect that only the marker-delta method is subject to the limitation that it can only be applied to emissions that are within 2 MHz of the authorized band edge (i.e. the integration method is not subject to the same limitation).

Please contact Rhein Tech directly if you have additional questions or require testing and certification assistance.  703.689.0368

On June 2, 2014, the FCC published 594280 D01 Configuration Control v02 providing guidance on permissible options and restrictions on configuration controls for devices not approved as Software Defined Radios.

Additionally, the FCC revised (FCC 14-30, ET Docket No. 13-39) the rules (effective June 2, 2014) for U-NII devices operating under Part 15 rules to require such devices to implement software security to ensure that the devices operate as authorized and cannot be modified.  (594280 D02 U-NII Device Security v01 provides guidance on the information that must be provided in the application filing to show that proper security is implemented in the device).

The FCC has established the following transition plan:

  • New devices will be permitted to be approved under the old rules for until June 1, 2015.
  • Starting June 2, 2016, permissive changes will not be permitted for devices approved under the old rules, unless they meet the requirements of the new rules.
  • All devices partially or completely approved under the old rules cannot be marketed starting June 2, 2016 unless they meet the requirements of the new rules in all the bands of operation.
  • Applications for devices for approval under the new rules must apply all of the applicable test procedures for such devices and provide software security documentation as discussed in the guidance 594280 D02 U-NII Device Security v01. This also applies to all applications for new devices and applications for permissive changes of previously approved devices.

Also, please note that effective January 1, 2015 equipment authorization applications for all new Wi-Fi Client devices capable of operating on Channels 12 and 13 (in 2.4 GHz band under Part 15 rules) must demonstrate compliance with the guidance in 594280 D01 Configuration Control v02. Wi-Fi Client devices capable of operating on Channels 12 and 13 approved prior to that date and otherwise relying on passive scanning modes may be marketed without modification after that date.

Please contact Rhein Tech directly if you have additional questions or require testing and certification assistance.  703.689.0368

During late May 2014, the Environmental Protection Agency (EPA) published ENERGY STAR Program Requirements for Computers, Draft Test Method version 6.1 which now includes Slate/Tablet devices and Two-In-One Computers with notable additions below:

  •  Provided guidance that Slates/Tablets or Two-In-One Computers shall be configured in a manner identical to Notebooks unless otherwise specified.
  • Provided clarification to luminance requirement to load three vertical bar video signal with default application for a Slate/Tablet or Two-In-One Computer.
  • Added luminance requirements to test Slates/Tablets at a 200 cd/m2 minimum. Additionally, Two- In-One Computers shall be tested similar to Notebooks at 90 cd/m2.
  • Added requirement for Slates/Tablets or Two-In-One Computers to configure the ENERGY STAR test image with a default image display application.
  • Added additional reporting test, specifying that Notebook Computers and Two-In-One Computers repeat the Short Idle test with the display brightness set to the closest setting that is at least 200 cd/m2. Additionally, Slates/Tablets shall repeat the Short Idle test with the display brightness set to the closest setting that is at least 90 cd/m2.
  • Added additional requirement to disable cellular function for testing and added clarifying language to leave Bluetooth as shipped.

 

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

Recently, Health Canada published a public consultation notice including its draft Safety Code 6 guidelines (2014). Industry Canada is reminding manufacturers of their obligations to meet Health Canada's Safety Code 6 limits adopted in Industry Canada's RSS-102 and additional points below made at the April 2014 TCB Workshop:

  • Industry Canada recommends that manufacturers take the draft limits into consideration during the design and testing phases of their devices, including compliance distance in their user manual.
  • Industry Canada will incorporate official Safety Code 6 limits (2014) in RSS-102 Issue 5.
  • Industry Canada will immediately use RSS-102 Issue 5 for the purposes of certifying new equipment.
  • RSS-102 Issue 5 will take full effect 120 days from the date of publication for equipment certified prior to Issue 5.
  • After the transition period, all devices manufactured, imported or sold in Canada must be in compliance with the revised standard no matter when they were originally certified.

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

In April 2014, the European Union Association of Notified Bodies (EUANB) issued Technical Guidance Note 32 (TGN 32), on the Requirement for Detailed Results in Test Reports. The EUANB has noticed that test reports do not always contain test results and often times report only a "pass" or "fail" statement with no actual test results. The EUANB agreed that test reports must contain the actual test results, not just a pass or fail statement and full test data is an essential part of the test report which allows manufacturer to sign their Declaration of Conformity.


To find out more, please contact Rhein Tech Laboratories, Inc. at sales@rheintech.com or call us at 703.689.0368

On May 16, 2014, the FCC published 388624 D02 Permit But Ask List v15r01 which replaces 388624 D02 Permit But Ask List v15. Fixed devices in the U-NII-1 band were added.

 

 

The FCC has scheduled a Communications Security, Reliability, and Interoperability Council (CSRIC) meeting for Wednesday June 18, 2014, beginning at 1:00 p.m., in the Commission Meeting Room at FCC Headquarters, located at 445 12th Street, SW, Room TW-C305, Washington, DC 20554.

The CSRIC is a federal advisory committee that provides recommendations to the FCC regarding best practices and actions the FCC can take to help ensure security, reliability, and interoperability of commercial and public safety communications systems, including: the reliability and security of communications systems and infrastructure; 911, Enhanced 911 (E911), and Next Generation 911; and emergency alerting.  This is the fourth meeting of the CSRIC and each working group will provide a progress report at the meeting. Votes are scheduled on reports for Working Group (WG) 1on Next Generation 911; WG 2 on Wireless Emergency Alerts; WG 3 on Emergency Alerting; WG 9 on Infrastructure Sharing During Emergencies, and WG 10 on CPE Powering. Each of the ten CSRIC Working Groups is described in more detail at http://www.fcc.gov/encyclopedia/communications-security-reliability-and-interoperability-council-iv

Members of the general public may attend the meeting. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The FCC will also provide audio and/or video coverage of the meeting over the Internet from the FCC's web page at www.fcc.gov/live.

 

 

 

On May 22, 2014, the Radio Equipment Directive 2014/53/EU (RED) was published in the Official Journal of the European Union. The RED will replace the R&TTE Directive 1999/5/EC on June 13, 2016 - after a two year transition period allowing manufacturers time to comply with the new Directive. The following are some key highlights of the new Directive:

  • The RED brings the Directive into line with the New Legislative Framework (NLF) which has replaced the 20 year old New Approach.
  • The RED introduces obligations for importers and distributors of radio equipment as well as manufacturers.
  • The RED scope includes broadcast receivers.
  • Telecommunications Terminal Equipment, with no radio interface, are no longer within the Directive's scope, but instead will be within the scope of the Low Voltage Directive (LVD) 2014/35/EU and the Electromagnetic Compatibility (EMC) Directive 2014/30/EU.

Please contact Rhein Tech directly if you have additional questions or require testing and/or certification assistance.  703.689.0368

Previously, we announced Vietnam's Ministry of Information and Communications (MIC) publishing of regulation No. 05/2014/TT-BTTTT requiring WIFI equipment operating in frequency bands of 2.4GHz and/or 5GHz to meet the additional compliance requirements of QCVN18:2010 (equivalent to EN 300 339:1998) with an effective date of May 5, 2014.  We were recently advised by our local agent that existing  Type Approvals do not need to be updated under the new QCVN 18:2010/BTTTT regulation and products approved before May 5, 2014do not need to be re-approved or updated under QCVN 18:2010/BTTTT; thsoe certificates will be valid until their expiration date.

 

Please contact Rhein Tech directly if you have additional questions or require testing and/or certification assistance.  703.689.0368

On May 16, 2014, the FCC published a series of questions and answers relating to the new U-NII rules which go into effect on June 2, 2014 and the U-NII transition plan. The questions are as follows and answers can be found at this link:

  1. What are the effective dates for the U-NII rules adopted by the Commission in ET Docket No. 13-49 (FCC 14-30)?
  2. What is the transition period during which "Old Rules" can be used to show compliance?
  3. How long can the devices approved, under the "Old Rules", be marketed without a new application?
  4. Can a Class II permissive change application be filed for a non-SDR device under the "New Rules" in one U-NII sub-band while operating under the old U-NII rules in another sub-band?
  5. Can a permissive change application be filed for an SDR device under the "New Rules" in one U-NII sub-band while operating under the old U-NII rules in another sub-band?
  6. Are there different test compliance procedures under the "Old Rules" and the "New Rules"?
  7. What are the filing requirements for presently approved U-NII-1 devices to operate outdoors under the "New Rules"?
  8. Can a device currently approved under the "Old Rules" (§ 15.247 or § 15.407) for operation in U-NII-3 band be approved under permissive change procedures to operate under the "New Rules" for U-NII-1 band and outdoor fixed operation?
  9. Can a U-NII-2A and 2C device presently approved under the interim procedure (KDB Publication 443999) be authorized to operate in the TDWR band? Is there a requirement for permissive change?
  10. Can a device presently approved under the "Old Rules" in § 15.247 (equipment class DTS) operate under the "New Rules" for U-NII-3 devices with equipment class NII?
  11. How long will devices continue to be approved under the "Old Rules"?
  12. Do we have to update filings for all operating devices?
  13. If a device has been previously certified in only one U-NII sub-band, can it be approved for additional U-NII sub-bands? Can the manufacturer file this change as a permissive change?
  14. Is it possible for a device approved under the "Old Rules" in the U-NII-3 band to be approved for operation in the additional 25 MHz recently added to the U-NII-3 band?
  15. Is there a grant condition or comment to show the device is approved under the "New Rules"?
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