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MultiPoint Newsletter - December 2017

Biomedical Telemetry Device Certification

Question: We have a biomedical telemetry device that operates using VHF and UHF television broadcast bands and we would like to certify it. Which FCC rules and regulations govern such a device?

Answer: The FCC allows biomedical telemetry devices to operate per the following rules:

  • Part 95 Subpart H Channel 37 band (608-614 MHz). Part 95 Subpart H - Wireless Medical Telemetry Service (WMTS) is a licensed service requiring a registration process prior to operation as stated in Section 95.2309. WMTS operation is also permitted in the 1395-1400 MHz band, and in portions of the 1427-1432 MHz band, where the available frequencies vary by geographic location.
  • Section 15.241 within the band 174-216 MHz (TV channels 7 to 13) and limited to Biomedical Telemetry Devices confined to an emission bandwidth of 200 kHz within the 176-216 MHz band.
  • Section 15.242 in TV channel bands 7 to 46 (174-216 MHz and 470-688 MHz) and limited to Biomedical Telemetry Devices employed within health care facilities and limited to operate within a single 6 MHz bandwidth TV channel as defined in Part 73.

Please note that equipment authorizations per Sections 15。241 and 15。242 have not been permitted since October 2002, per Section 15。37(b)。 Legacy operations are permitted however。

In all cases, Biomedical Telemetry and WMTS devices intended for operation must be certified under the equipment authorization provisions of Part 2 Subpart J. Biomedical Telemetry Devices must not cause harmful interference to licensed TV broadcast stations, or to other authorized radio services, and the operator of a device must accept whatever interference is received.

The recent broadcast television spectrum incentive auction has resulted in the repurposing of TV channels 38-51 for licensed wireless services, and some TV stations that remain on the air will be required to change their channels of operation. These changes may create interference to existing medical telemetry devices or result in harmful interference to authorized services, requiring alteration of the operating channel for some devices.

Channel 37 (608-614 MHz) is not assigned to any television broadcaster, and is a coordinated, shared channel for WMTS devices under Section 95。2309 generally, and the National Astronomy and Observatory Centers (NRAO) under Section 95。2309(f)。

Subpart H of Part 95 describes the requirements for transmitters operating in the WMTS. WMTS devices in the 608-614 MHz band must have the capability to operate in one or more of the 1.5 MHz channel(s) specified in Section 95.2363(b). Spread spectrum devices that operate in the WMTS bands under Part 95 Subpart H require the 1.5 MHz channel mode in the event there are frequency coordination issues as specified in Section 95.2325.

Certification applications should have specific test data for the 1。5 MHz channel mode at the supported Section 95。2363(b) frequencies, along with test data for other operating modes if supported by a device。

In addition, there should be multiple Form 731 line entries (one for each transmit mode) and grant conditions stating that there is a 1。5 MHz channel mode, to support frequency coordination if the spread spectrum mode causes frequency coordination issues。

This information can also be found 。

Other general information on medical telemetry devices can be found on the FCC webpage: .

斗地主达人A listing of the current DTV channel assignments can be found .

Other information on medical telemetry operations is available from the US Food and Drug Administration (FDA): 。

Multiple Rule Part Transmitters

Question: Will the FCC restrict us from certifying our device if it operates under multiple rule parts?

Answer: FCC Section 2.1033(e) permits certification of transmitting devices that are subject to multiple rule parts. At a minimum, the device must comply with the technical requirements for each applicable rule part; multi-rule applications must clearly demonstrate compliance with all technical requirements in each separate rule part.

The FCC published KDB 149672 D01 Xmit Certified Mult Rule Parts v02斗地主达人 on December 8, 2017, updating the previous version, in order to provide guidance on radio transmitters operating under multiple rule parts, including the requirements for composite devices with multiple transmitters per FCC Section 2.947(f). All combination devices must meet the radio parameter and RF exposure requirements. There may also be additional requirements or restrictions per the Wireless Telecommunications Bureau (WTB).

MedRadio Transmitter Testing

Question:斗地主达人 Is it acceptable to use the torso simulator and tissue-equivalent material previously specified in Part 95 rules for testing of MedRadio transmitters in cardiac pacemaker and defibrillator implants?

Answer: provides a detailed response as follows:

Testing of transmitters used for medical implant devices authorized under the MedRadio rules is required to determine compliance with radiated emission and EIRP limits (see Sections 95。2567, 95。2569, and 95。2579)。 The MedRadio rules in the present Section 95。2569(c) (numbered as Section 95。627(g)(3)(i) when originally adopted by the Commission on March 19, 2009) require that a "Commission-approved human body simulator and test technique" be used for testing 401-406 MHz implant transmitters。

The FCC will continue to accept devices tested to the procedures in place before 2009, as described below.

Medical implant transmitters shall be tested for emissions and EIRP limit compliance while submersed in a medium that simulates human body tissue with the required dielectric properties. For a transmitter intended to be implanted in a human body, a test set-up as described in the following paragraph must be used to simulate operation of the implant under actual operating conditions. Simple saline solutions do not meet the above criteria.

  • For measurement purposes, and to determine compliance with emission limits, the radiating characteristics of a MedRadio implant transmitter placed in a test fixture should approximate those of an implant transmitter placed in a human body.
  • An appropriate human torso simulator (phantom) for testing medical implant transmitters should consist of a cylindrical Plexiglas container, measuring 30 cm in diameter and 76 cm long, with a sidewall thickness of 0.635 cm.
  • The human torso simulator must be completely filled with a tissue-equivalent material that is sufficiently fluidic and flows around the implant without any voids.
  • The permittivity and conductivity of the tissue-equivalent material must match the dielectric parameters of the body tissue-equivalent properties in KDB Publication 865664 at 403.5 MHz. Example tissue mixture recipes are available in IEEE Std 1528-2013. The dielectric parameters must be measured and must satisfy the required target values.
  • All emission measurements shall be made using the above specification at a nominal tissue-equivalent material temperature of 20°C to 25°C.
  • A low-loss mounting grid for the implant inside the container that permits the radiating element or elements of the implant to be positioned vertically and horizontally must be used. The mounting grid shall not perturb the emission results and must also support in a fixed repeatable manner any additional implant leads associated with the therapeutic function.
  • The implant must be mounted 6 cm from the sidewall and centered vertically within the container.
  • The aforementioned liquid-filled phantom with mounting grid shall be placed on a turntable such that the implant transmitter is located at a nominal 1.5 m height above ground and at a 3 m distance from the measurement antenna. Radiated emissions measurements shall then be performed to ensure compliance with the applicable technical specifications.

Radio Equipment Directive Compliance Association

Question: Does the EU have an organization to disseminate information on conformity assessment in the EU, similar to the TCBC and the FCC?

Answer: The EU has the REDCA (Radio Equipment Directive Compliance Association) for conformity assessment procedures, to ensure consistent application by all parties in order to achieve an open and competitive market throughout Europe.

The REDCA also contributes to the effective implementation of relevant legislation in cooperation with the Committee set up under the Directive (i。e。 TCAM), and facilitates the convergence of conformity assessment practices in the regulatory sphere。 The REDCA interfaces with relevant organizations such as ETSI, ECC and ADCO RED。

The REDCA issues information sheets, called Technical Guidance Notes (TGNs) that are developed to assist the notified bodies in their tasks. The TGNs may also contain valuable background information for manufacturers.

Standards Updates

EU: New CENELEC Standards Recently Released

This is a shortened list of the CENELEC standards published or made available during the past month:

  • - 12/13/2017 - Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017)
  • - 12/13/2017 - General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017)
  • - 12/15/2017 - Investigation Results on Electromagnetic Interference in the Frequency Range below 150 kHz

See for additional information.

EU: New ETSI Standards Recently Released

This is a shortened list of the new ETSI standards published during the past month:

  • - (December 2017) - Satellite Earth Stations and Systems (SES); Harmonised Standard for fixed and in-motion Earth Stations communicating with non-geostationary satellite systems (NEST) in the 11 GHz to 14 GHz frequency bands covering essential requirements of article 3.2 of Directive 2014/53/EU

See for additional information.

EU: New IEC Standards Recently Released

This is a shortened list of the new IEC standards published during the past month:

  • - (12/13/2017) - Electrical energy storage (EES) systems - Part 2-1: Unit parameters and testing methods - General specification
  • - (12/13/2017) - Explosive atmospheres - Part 0: Equipment - General requirements
  • - (12/14/2017) - Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data
  • - (12/13/2017) - Semiconductor devices - Mechanical and climatic test methods - Part 12: Vibration, variable frequency
  • - (12/13/2017) - Semiconductor devices - Semiconductor interface for automotive vehicles - Part 1: General requirements of power interface for automotive vehicle sensors

See for additional information.

Vietnam – New RF Standard

Vietnam’s Ministry of Communications (MIC) recently released Circular No。 18/2017/BTTTT introducing the new EMC RF standard QCVN 112:2017/BTTTT。

This new standard dated Sep. 11, 2017, for Broadband Radio Transmission Equipment and data transmission equipment, will go into effect July 1, 2018. This new standard, together with QCVN 18: 2014/BTTTT, designates the requirements for electromagnetic compatibility (EMC) for wireless broadband transmitters listed below:

  • Radio communication equipment using spread spectrum modulation techniques in the 2.4 GHz band;
  • Radio access equipment operating in the frequency band 5150 MHz to 5350 MHz, 5470 MHz to 5725 MHz and 5725 MHz to 5850 MHz;
  • High-speed radio access equipment from 57 GHz to 66 GHz; and BWA/WiMAX broadband radio access equipment in both TDD and FDD modes.

斗地主达人Currently, not all of the local test laboratory accreditations are updated for this new standard, and the test labs cannot test and issue test reports until getting accreditation and guidance from the Vietnam MIC. Upon the effective date, the MRA lab’s Vietnam standard scope will need to include this new standard.

Valid and existing certificates do not need to be updated to the new standard. Only new and renewal applications after July 1, 2018 will need to be tested to the new standard.

EU – New RED Harmonized Standards Published

On December 15, 2017, the following new RED Harmonized standards were published in Official Journal of the European Union:

  • EN 300 698 V2.2.1: Radio telephone transmitters and receivers for the maritime mobile service operating in the VHF bands used on inland waterways; Harmonized Standard covering the essential requirements of articles 3.2 and 3.3(g) of Directive 2014/53/EU
  • EN 302 054 V2.1.1: Meteorological Aids (Met Aids); Radio sondes to be used in the 400,15 MHz to 406 MHz frequency range with power levels ranging up to 200 mW; Harmonized Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
  • EN 302 454 V2.1.1: Meteorological Aids (Met Aids); Radio sondes to be used in the 1 668,4 MHz to 1 690 MHz frequency range; Harmonized Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
  • EN 303 276 V1.1.1: Maritime Broadband Radiolink operating within the bands 5 852 MHz to 5 872 MHz and/or 5 880 MHz to 5 900 MHz for ships and off-shore installations engaged in coordinated activities; Harmonized Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
  • EN 303 413 V1.1.1: Satellite Earth Stations and Systems (SES); Global Navigation Satellite System (GNSS) receivers; Radio equipment operating in the 1 164 MHz to 1 300 MHz and 1 559 MHz to 1 610 MHz frequency bands; Harmonized Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU

Reference link .

Indonesia – Paperwork-Only Type Approval Process

We have recently learned that Indonesia’s Authority, Direktorat Jenderal Sumber Daya dan Perangkat Pos dan Informatika (SDPPI), is considering introducing a new policy in 2018 whereby a paperwork-only Type Approval process will be permitted for all Product Categories. At this time in Indonesia, the paperwork-only Type Approval process is only permitted for cellular phones, handheld computers, and computer tablets.

Malaysia – New Requirement for Type Approval

On November 23, 2017, Malaysia’s Authority, SIRIM, announced all accompanying test reports submitted as support for product Type Approval must have a valid International Accreditation certificate/document with relevant work scope clauses included. All accreditations must be registered with SIRIM in their online system. This is a one-time process, unless the laboratory accreditation changes. This new requirement and registration process may cause delays to some Type Approval applications.

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