Source: http://www.hfytxx.com/multipoint-newsletter-april-2014
Timestamp: 2020-02-22 22:26:00
Document Index: 401986100

Matched Legal Cases: ['art 18', 'art 18', 'art 18', 'art 18', 'art 2', 'art 18', 'art 18', 'art 18', '§18', 'art 18', 'art 15', 'art 1', 'art 11', 'art 14', 'art 27', 'art 3', 'art 5', 'art 1', 'art 6', 'art 9', 'art 1', 'art 2', 'art 3', 'art 29', 'art 201', 'art 5', 'art 2', 'art 1', 'art 2', 'art 3', 'art 23', 'art 5', 'art 1', 'art 15']

﻿ MultiPoint Newsletter - April 2014
EU MDR and IVDR Preparation Conference this February
Does your company manufacture or market medical devices in the European Union? Then you’re probably aware of the upcoming implementation…
Ajit Pai Comments on Deployment of C-V2X in 5.9 GHz Band
On January 22, 2020, Audi, Qualcomm, and the Virginia Department of Transportation announced the deployment of a new C-V2X (Cellular…
FCC Issues Notice of Proposed Rule-Making for Shared Use in 3.1 - 3.55 GHz Band
On January 22, 2020, the FCC issued a Notice of Proposed Rulemaking: Facilitating Shared Use in the 3.1 - 3.55…
MultiPoint Newsletter - April 2014
Measurement Procedure for Non-Consumer ISM Device Testing
Question: We are testing a non-consumer Industrial Scientific Medical (ISM) device in accordance with of the FCC rules and regulations using ANSI C63.4: 2009. Is this correct?
Answer: No, it is not. In accordance with , when testing FCC Part 18 ISM devices, it is advisable to use the same measurement procedure to test your device that the FCC will use to determine compliance if they were testing the device. ANSI C63.4: 2009 is not the measurement procedure they would use. The required measurement procedure is MP-5, “Methods of Measurements of Radio Noise Emissions from ISM equipment".
斗地主达人Furthermore, please note that the field strength limits in are product-specific with respect to operating frequency, power and measurement distance.
FCC Label Requirements for Part 18 Devices
Question: We are about to start marketing our vendor’s FCC Part 18 devices. What are the labelling requirements for Part 18 devices?
Answer:斗地主达人 Equipment that intentionally generates radio frequency energy for non-telecommunications functions for industrial, scientific, medical (ISM) or other purposes must be authorized and labelled according to the procedures outlined in Part 2 Subpart J, and .
Non-consumer ISM equipment is authorized under the verification procedure。 Consumer ISM equipment is authorized under either the Declaration of Conformity or certification procedure, except for consumer ultrasonic equipment generating less than 500 watts and operating below 90 kHz, which is subject to the verification procedure。
Devices subject to verification must be permanently labelled with a unique identifier () to facilitate positive identification of the device. This identification should not be confused with the FCC ID used on devices subject to certification.
Devices subject to Part 18 certification must be permanently labelled with an FCC ID as described in .
Devices subject to Part 18 Declaration of Conformity must be permanently labelled with the Part 18 logo (FCC logo) in accordance with 47CFR§18。209b, in addition to a unique identifier to facilitate positive identification。 This identification should not be confused with the FCC ID used on devices subject to certification。
Please note that the FCC also has specific requirements for information to the user for Part 18 devices. These requirements can be found in 斗地主达人KDB 784748 D01 Labelling Part 15 &18 Guidelines v07.
Log Average Detector in Intentional Radiator Testing
Question: We are testing our intentional radiator using a log average detector. Is this type of detector allowed by the FCC?
Answer: The FCC does not allow log average detectors for compliance measurement in any rule part. There are three types of average detection that are commonly available in most modern spectrum analyzers:
Power averaging (also known as RMS), in which averaging is performed on the voltage-squared;
Voltage averaging (also known as linear averaging), in which averaging is performed on the absolute value of the voltage;
Log averaging (also known as dB averaging), in which averaging is performed on the log of the power, or log of the absolute value of voltage (i.e., averaging of decibels).
The language in the relevant rules and measurement procedures should determine which average detection method is utilized. For example, if a rule specifies a limit on average power or on average power spectral density, power averaging is required.
If a rule specifies average detection of the field strength, voltage averaging is required because field strengths are proportional to the voltage induced in the measurement antenna (for example, for measurements above 1000 MHz). In cases where voltage averaging is required, procedures may also permit the use of power averaging, because power averaging produces a measurement result that is equal to or greater than that of voltage averaging when the measurement results are converted to the same units.
R&TTE Compliance Association Guidance on CE Test Reports
Question: What guidance, if any, exists for the type of information that should be included in R&TTE CE test reports?
Answer: The R&TTE Compliance Association (R&TTECA) issued a guidance note last year, “Technical Guidance Note no. 18 on the Requirement for Real Results in Test Reports”. The guidance provided by the R&TTECA states that test reports must show actual test results and not just indicate pass/fail. It also lists the many reasons why the actual test results are necessary for manufacturers, Notified Bodies and market surveillance authorities to properly assess and maintain compliance with the R&TTE standards.
斗地主达人It is worth mentioning here that when performing Telecommunications Terminal Equipment (TTE) compliance testing, as would be done for mobile phones for example, Protocol Implementation Conformance Statement/Protocol Implementation Conformance Extra Information for Testing (PICS/PIXIT) files are automatically generated. These files contain a list of test configuration cases that are then automatically performed by the TTE test systems. Since the PICS/PIXIT files denote the exact test configuration cases used during the mobile phone testing, it is important that they be included in the test report for the Notified Body’s review.
EU: New CENELEC Standards Recently Released
This is a shortened list of the CENELEC standards published or made available during the past month:
- 3/21/2014 - Basic standard for the in-situ measurement of electromagnetic field strength related to human exposure in the vicinity of base stations
- 3/21/2014 - Environmental testing - Part 1: General and guidance
- 3/21/2014 - Fire hazard testing - Part 11-2: Test flames - 1 kW nominal pre-mixed flame: Apparatus, confirmatory test arrangement and guidance
- 3/28/2014 - Explosive atmospheres - Part 14: Electrical installations design, selection and erection
- 3/28/2014 - Measuring relays and protection equipment - Part 27: Product safety requirements
- 3/28/2014 - Coupling capacitors and capacitor dividers - Part 3: AC or DC coupling capacitors for harmonic-filters applications
- 3/28/2014 - Mechanical structures for electronic equipment - Tests for IEC 60917 and IEC 60297 - Part 5: Seismic tests for chassis, subracks and plug-in units
- 3/28/2014 - Measurement of DC magnetic, AC magnetic and AC electric fields from 1 Hz to 100 kHz with regard to exposure of human beings - Part 1: Requirements for measuring instruments
- 4/11/2014 - Low-voltage switchgear and controlgear - Part 6-1: Multiple function equipment - Transfer switching equipment
- 4/18/2014 - Fire hazard testing - Part 9-2: Surface spread of flame - Summary and relevance of test methods
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:
- March 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Additional ElectroMagnetic Compatibility (EMC) requirements and resistibility requirements for telecommunications equipment for enhanced availability of service in specific applications
- March 2014 - Reconfigurable Radio Systems (RRS) ; Use Cases for dynamic equipment reconfiguration
- March 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference document (SRdoc); Technical characteristics for pan European harmonized communications equipment operating in the 5,855 GHz to 5,925 GHz range intended for road safety and traffic management, and for non-safety related ITS applications
- March 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Definition of radio parameters
- April 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Land Mobile Service; Multichannel transmitter specification for the PMR Service; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
- April 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive; Part 1: Requirements for Generic UWB applications
- April 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive; Part 2: Requirements for UWB location tracking
- April 2014 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive; Part 3: Requirements for UWB devices for road and rail vehicles
EU: New IEC Standards Recently Released
This is a shortened list of the new IEC standards published during the past month:
- (3/27/2014) - Explosive atmospheres - Part 29-3: Gas detectors - Guidance on functional safety of fixed gas detection systems
- (3/27/2014) - High-voltage switchgear and controlgear - ALL PARTS
- (3/27/2014) - High-voltage switchgear and controlgear - Part 201: AC solid-insulation enclosed switchgear and controlgear for rated voltages above 1 kV and up to and including 52 kV
- (4/1/2014) - Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 5: Competence requirements for auditing and certification of asset management systems
- (4/10/2014) - Home control systems - Guidelines relating to safety
- (4/10/2014) - Safety of transformers, reactors, power supply units and combinations thereof - Part 2-10: Particular requirements and tests for separating transformers with high insulation level and separating transformers with output voltages exceeding 1 000 V
- (4/10/2014) - Discharge lamps (excluding fluorescent lamps) - Safety specifications
- (4/10/2014) - Railway applications - Procedure to determine the performance requirements for radio systems applied to radio-based train control systems
- (4/10/2014) - Alarm and electronic security systems - Social alarm systems - Part 1: System requirements
- (4/10/2014) - Alarm and electronic security systems - Social alarm systems - Part 2: Trigger devices
- (4/10/2014) - Alarm and electronic security systems - Social alarm systems - Part 3: Local unit and controller
- (4/8/2014) - Wind turbine generator systems - ALL PARTS
- (4/8/2014) - Wind turbines - Part 23: Full-scale structural testing of rotor blades
- (4/10/2014) - Alarm and electronic security systems - Social alarm systems - Part 5: Interconnections and communications
- (4/15/2014) - Wind turbines - Part 1: Design requirements
FCC - "Permit But Ask" List and Procedures Revised
On April 9, 2014, the FCC published which replaces 388624 D02 Permit But Ask List v14r01. This new version adds items from the TCB Exclusion List, and includes changes made to implant transmitters, Doppler radar, CMRS industrial boosters, and LTE Rel. 8. Additionally, the FCC published 388624 D01 Permit But Ask Procedures v10 which replaces 388624 D01 Permit But Ask Procedure v09r03. PBA categories have been added to address the addition of items formerly on the TCB Exclusion List.
FCC - 5 GHz Spectrum Open for Unlicensed Devices
On March 31, 2014, the FCC adopted Revision of Part 15 of the FCC's rules to Permit Unlicensed National Information Infrastructure (U-NII) Devices in the 5 GHz Band, which modified the rules for operations of Unlicensed National Information Infrastructure (U-NII) devices in the 5 GHz band. FCC 14-30 opens up 25 MHz of new spectrum for 5 GHz unlicensed devices, allows outdoor operation of U-NII devices on spectrum where indoor-only operation was previously allowed, and harmonizes rules across the U-NII bands, allowing increased power in some bands.
US - FCC Proposal to Enable Broadband in MSS System
斗地主达人The FCC recently published a . The FCC proposed to modify its rules for operation of the Ancillary Terrestrial Component (ATC) of the single Mobile-Satellite Service (MSS) system operating in the 2483.5-2495 MHz band. The proposed rule changes would allow the MSS operator to deploy a low-power terrestrial broadband network that would operate in both Globalstar's licensed spectrum at 2483.5-2495 GHz, and, with the same equipment, spectrum in the adjacent 2473-2483.5 MHz band used by unlicensed devices.
Manufacturer Impact / Challenges: This action could potentially increase the amount of spectrum available for broadband access in the United States。 The FCC seeks comments on the potential impacts this proposal could have on unlicensed devices which operate in the 2400-2483。5 MHz band, on licensed Broadcast Auxiliary Service (BAS) stations which operate in the 2483。5-2500 MHz band, and on licensed Broadband Radio Service/Educational Broadband Service (BRS/EBS) stations which operate in the 2496-2690 MHz band, along with the costs and benefits of the proposed approach。
EU - Medical Devices Covered by RoHS 2 Directive
Beginning July 22, 2014, medical devices will be included within the scope of the RoHS Directive (2011/65/EC)。 Since 2003 the EU has restricted the use of hazardous substances in electrical and electronic equipment and this will now be expanded to include medical devices。
Medical device manufacturers will be required to demonstrate compliance with the RoHS Directive which sets maximum levels for materials such as heavy metals (lead, mercury, hexavalent chromium and cadmium) as well as for brominated flame retardants (PBB and PBDE). In this context, a medical device is any instrument, piece of apparatus, etc. designed to be used for diagnostic or therapeutic purposes. However, implanted products which remain in the patient's body are excluded. Laboratory equipment for in vitro diagnosis will be included in the scope starting July 22, 2016 (two years later than the other devices listed).
Some of the devices covered by the new RoHS requirements are:
Pulmonary Ventilators
Fertilization Tests
Other appliances for detecting, preventing, monitoring, treating, alleviating illness, injury or disability
Additional information can be found .
EU –Technical Guidance Note on EMF Requirements (TGN 17)
During February 2014, the European Union Association of Notified Bodies (EUANB) issued (TGN 17) on EMF requirements for products under the R&TTE Directive, and - mobile phones for young children. TGN 17 provides guidance for demonstrating compliance to EMF requirements under article 3.1a of the R&TTE 1999/5/EC Directive. The health requirement applies to electrical and radio electrical, and home and industrial appliances covered as well by the Low Voltage Directive.
斗地主达人The EMF generic standard EN 62311, which is harmonized under both LVD and R&TTE Directives, provides presumption of conformity against EMF requirements. However, there are many standards which also provide presumption of conformity, considering that the need for SAR measurement (head and body or limbs) may depend on the intended use of the equipment. In some cases it is possible just to measure the Electro Magnetic field (to determine a safe distance) and/or induced current in the body, or even demonstrate conformity by calculating the reference input consumed power or maximum radiated output power.
The application of product standards takes precedence over the generic standards. In cases where the applied standard is not harmonized, a Notified Body should be involved in the conformity assessment process before placing that equipment on the market.
Annex A to TGN 17, Notification Belgium prohibits mobile phones designed specifically for young children from being placed on the Belgian market.
EU - Revised CE Marking Directives
On March 29, 2014, the European Commission (EU) published eight revised CE marking directives which are aligned with the rules and responsibilities for CE marking that were published in Decision 768/2008/EU earlier this year. These new directives are in effect as of 4/19/2014 and member states have until 4/20/2016, when the old directives will be repealed, to change and/or amend their national legislation. Please note these eight directives have the following new directive numbers:
(previously 2004/108/EC): Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to electromagnetic compatibility
(previously 2006/95/EC): Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to the making available on the market of electrical equipment designed for use within certain voltage limits
(previously 94/9/EC): Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to equipment and protective systems intended for use in potentially explosive atmospheres
(previously 93/15/EC): Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to the making available on the market and supervision of explosives for civil uses
(previously 2009/105/EC): Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to the making available on the market of simple pressure vessels
: Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to the making available on the market of non-automatic weighing instruments
: Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to the making available on the market of measuring instruments
: Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member states relating to lifts and safety components for lifts
China - Modular Approval Now Allowed
On January 2, 2014, China's Ministry of Industry and Information Technology (CMIIT) published the official notification [2014] No. 1 regarding type approval of non-independently operating wireless transmitting modules. Based on this notification, began to accept applications for modular approval and issue Type Approval certificates with a 5 year validity.
If the module is a "Full module" and complies with 5 criteria, it should be type approved and labelled with a CMIIT ID No.. On the product label or in the user manual for the end device in which such a module is installed, it is mandatory to print the following statement: "This equipment contains wireless transmitting module with CMIIT ID: XXXXYYZZZZ". For this type of modular approval, the manufacturer can use this approved module in an end product without having to retest or recertify the end product.
If the module is a "Limited module”, it can be type approved with a CMIIT ID No。, including the mark "M"。 End products such as laptops, PCs, printers, and household appliances, in which such a module is installed, still need to be type approved again with additional testing。 A new CMIIT ID No。 will be issued to the approved end product system。
Argentina - Host-level Approval Required for Devices with RF Modules
On February 18, 2014, Argentina's Communications Authority, Nacional de Comunicaciones (CNC), released Norma which states that host level approval is now required for devices containing RF modules. Approval of RF modules is still permitted but the host device must be approved as well. Approval of RF modules is now only advantageous in cases where the module is imported on its own and intended for integration into products once in Argentina.
This regulation applies to low power RF devices tested in accordance with CNC-Q2-60.14 V12.1 only and covers devices such as:
Alarms and Motion Detectors
Wireless audio devices, including Microphones
Additionally, these RF devices operate in the following frequencies:
57.5 kHz - 67.5 kHz
105 kHz - 135 kHz
3.155 MHz - 3.400 MHz
10.6 MHz
13.553 MHz - 13.567 MHz
88 MHz - 108 MHz
138.20 MHz - 138.45 MHz
216 MHz - 217 MHz
310 MHz - 314 MHz
402 MHz - 405 MHz
433.075 MHz - 434.775 MHz
902 MHz - 928 MHz
Vietnam – New EMC Requirement for 2.4 GHz and 5 GHz Wi-Fi Devices
On March 19, 2014, Vietnam's Ministry of Information and Communications (MIC) published regulation No。 requiring Wi-Fi equipment operating in the frequency bands 2。4 GHz and/or 5 GHz to meet the additional compliance requirements of QCVN18:2010 (equivalent to EN 300 339:1998)。 This new regulation comes into effect on May 5, 2014。
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