Test Methods of Electromagnetic Compatibility In-situ for Large Medical Equipment or System 【ON-SITE (IN-SITU) EMC TESTING】
Electromagnetic compatibility testing of medical equipment in my country has been mandatory. Large medical equipment or systems often have characteristics such as large size, inconvenient transportation, relatively fixed installation, and large rated power supply current (here specifically refers to each phase current greater than 16 A), such as MRI, DR , cascade biochemical analyzers, high-power sterilizers, hyperbaric oxygen chambers, etc.
This type of equipment is more complex than conventional medical equipment in terms of test layout and cable connections. Due to the special requirements of the installation environment and usage environment, some equipment or systems are often inconvenient to conduct electromagnetic compatibility testing in a laboratory environment, and the equipment needs to be tested and evaluated at the installation site.
Similarly, there are large industrial equipment systems (for example, various large energy storage cabinets, charging stations, heavy industry equipment, large frequency converter cabinets, drying ovens, high-power motors, etc.), etc. due to fixed installation, large size, and inconvenient transportation. , large rated power supply current, and even some require separate other auxiliary support systems, etc., it is often impossible to complete electromagnetic compatibility testing in the laboratory. At this time, EMC on-site testing needs to be performed at the customer’s product site.
GZSA can provide one-stop technical services such as on-site EMC testing, non-conformity EMC debug, standard technical consultation, and registered inspection reports in China and across the country.
Mr Zeng specializes in the field of electromagnetic compatibility, providing customers with professional EMC testing, safety testing, withstand voltage testing, leakage current testing, grounding resistance testing, high and low temperature testing, reliability testing, and various certifications, providing one-stop service , more can contact Mr Zeng 139 2899 3907 (same number on WeChat).
Contact Mr Zeng for EMC debug of medical surgical robot
In the medical device industry, surgical robots usually belong to the third category of medical treatment. The National Medical Products Administration (abbreviated as NMPA) usually carefully reviews such devices. Therefore, we need to take seriously the technical data, product specifications, document specifications and corresponding test reports. Among them, it is believed that many of these surgical robot enterprises will face some technical difficulties, for example, the core components such as mechanical arms and consoles are purchased from foreign countries or other suppliers. These foreign manufacturers or domestic suppliers will not provide more information or better cooperation. In particular, when the surgical robot fails to pass the electromagnetic compatibility test, safety regulation test, withstand voltage test, leakage current test and grounding resistance test, it will be helpless. It makes enterprises face great difficulties in the process of registration to listing, and brings great frustration to corresponding enterprises, registered engineers, and even some professional teachers responsible for registration.
Surgical robot
The biggest problem encountered by surgical robots in the process of medical device registration, the determination of corresponding technical parameters, and clinical trials. Then, it is the safety test of the corresponding EMC electromagnetic compatibility and safety regulations. These two pieces need very professional engineers with relevant industry experience and corresponding laboratories, so as to effectively predict the EMC problems and safety problems of surgical robots in advance. Even when the project is put on file and the project is reviewed, the safety regulations and electromagnetic compatibility should be evaluated in advance. Instead, it is risky to buy all the parts and key parts, and then do the test in reverse.
Common classification of medical surgical robots
Medical robots refer to the robots used for medical treatment or auxiliary medical treatment in hospitals and clinics; It is a kind of intelligent service robot, which can independently prepare operation plans, determine action programs according to the actual situation, and then turn the action into the motion of the operating mechanism.
According to different purposes, medical robots can be divided into hospital distribution robots, mobile patient robots, clinical medical robots, rehabilitation robots, nursing robots, medical teaching robots, etc.
Clinical medical robot
Clinical medical robots include surgical robots, diagnosis and treatment robots, which can perform precise surgical operations or diagnosis, such as Japan’s WAPRU-4 chest tumor diagnosis robot; The American surgical robot “Da Vinci system” is the top priority of medical robots.
The first robot assisted surgery was performed in 1985. At that time, industrial robots were used to stabilize the patient’s head, so as to facilitate neurosurgery drilling and inserting tissue sampling needles into designated positions.
The “Da Vinci” robot is the most famous in the industry, and its success is partly due to its FDA approval for clinical use; The domestic Tianzhihang Company has also obtained the registration license of surgical robot medical devices issued by the National Medical Products Administration (abbreviated as NMPA, Formerly called CFDA) , becoming the only orthopedic robot system capable of carrying out traumatic orthopedic and spinal surgery in the world.
Ophthalmic surgery robot
Orthopedic surgical robot
Dental assistant robot
Gastroscope robot
Common components of medical surgical robots
It mainly consists of a console and an operating arm. The console consists of a computer system, a surgical operation monitor, a robot control monitor, an operating handle, an input/output device, etc. During the operation, the surgeon can sit in front of the console far away from the operating table, lean his head on the field frame, receive complete images from different cameras with both eyes, and jointly synthesize the three-dimensional stereogram of the surgical field. The doctor controls the operating lever with both hands, and the hand movement is transmitted to the tip of the mechanical arm to complete the surgical operation, thus increasing the accuracy and stability of the operation. This is a new master slave remote operation mode.
Generally, surgical robots are composed of the following major technical systems
Surgical navigation and positioning technology (infrared optical positioning and other technologies)
Surgical robot structure and mechanical arm
Image processing system of surgical robot
Difficulties in EMC debug(rectification) of surgical robot
Surgical robot enterprises will face some technical difficulties. For example, core components such as mechanical arms and consoles are purchased from foreign countries or other suppliers. In this way, it will be very difficult to test and rectify your own compliance and compliance with the corresponding standards.
The mechanical arm and other moving parts of the surgical robot use all kinds of stepping motors, which are usually driven by pulses. In this way, the voltage and current change rate of dv/dt and di/dt is very large, and the same interference is very large, which brings challenges to EMC design and rectification.
The console of the surgical robot usually includes high-speed DSP, CPU and other processors. Because of the need for high-speed and high-precision computing and positioning, high frequency image processing, high-speed transmission of gigabit networks, 5G networks, and the need to display real-time images of the surgical scene through high-speed displays, it will involve a lot of digital interference of high-speed data processing chips.
Console, mechanical arm, navigation and monitoring of surgical robot often need physical cable connection to form a complete system, so that all kinds of cables will form a very large equivalent transmission antenna, making it easier to transmit interference through these cables. Therefore, these cables need special treatment.
Similarly, because of the existence of positioning and navigation, some use various laser, ultrasonic and other technology radar and other positioning technologies. These signals and their echoes, their PCB circuits often bring very big interference, and these intentionally emitted interference is relatively difficult to deal with.
Finally, a more important thing is the power supply system. Some of them also come with UPS, which should meet the medical standard requirements of IEC 60601-1 IEC 60601-1-2, including the design margin requirements. This type selection is very important.
YY 0505 – 2012 – YY 9706.102 GB 4824 Radiation Test – V
YY 0505 – 2012 – YY 9706.102 GB 4824 Radiation Test – H
YY 0505 – 2012 – YY 9706.102 GB 4824 Conduction Test – L
YY 0505 – 2012 – YY 9706.102 GB 4824 Conduction Test – N
Who can the surgical robot find to EMC debug(rectify), and what are its advantages?
EMC testing of medical devices
We have experience in EMC design and rectification of surgical robots at home and abroad, including successful inspection, testing and reporting in the National Medical Device Testing Institute, which can provide customers with more mature experience.
With a professional CNAS national recognized laboratory, it can provide customers with accurate test data and reliable precautions in the inspection process, reduce the uncertainty of test data, and improve the confidence of the national laboratory for final inspection.
We have a professional technical team. We are not alone in technical research, but a team with more than 10 years of experience. Before the release of YY 0505 – 2012 in China, we were engaged in the safety regulation and electromagnetic compatibility testing, rectification and design of European medical devices in EN/IEC 60601-1 – 2.
The team with professional service quality can provide enterprises with accelerated and urgent processing, and can cooperate with overtime processing. The laboratory is located near the National Inspection Institute, which can facilitate data comparison, confirm the data of the national laboratory, and ensure the consistency of the predicted rectification data, so that the national inspection center can better pass at once.
It can provide YY 9706-102-2021 YY 0505 – 2012 GB 9706.1-2020 and other standard analysis, standard answers and standard training, which can enable enterprises to better understand standards and product compliance.
We not only provide inspection, rectification and design to the certification stage, but also help enterprises to introduce production and normalize the mass production of products, so that we can truly absorb the experience in the registration and inspection process, so as to minimize the risk of national medical flight inspection.
ECE R10 is one of the regulations published by The United Nations Economic Commission for Europe (UNECE) for automotive industry. UNECE has 56 member states as of 18 February 2020. ECE R10 is defining Electromagnetic Compatibility requirements of the vehicles and electronic sub assemblies (ESAs) used in automotive. It explains both EMC tests and type approval of the product.
WHICH PRODUCTS ARE UNDER THE SCOPE OF ECE R10?
As given on the scope of ECE R10, the regulation applies to:
1.1. Vehicles of categories L, M, N O, T, R and S1 with regard to electromagnetic compatibility;
1.2. Components and separate technical units intended to be fitted in these vehicles with the limitation given in paragraph 3.2.1. with regard to electromagnetic compatibility.
1.3. It covers: (a) Requirements regarding the immunity to radiated and conducted disturbances for functions related to direct control of the vehicle, related to driver, passenger and other road users’ protection, related to disturbances, which would cause confusion to the driver or other road users, related to vehicle data bus functionality, related to disturbances, which would affect vehicle statutory data; (b) Requirements regarding the control of unwanted radiated and conducted emissions to protect the intended use of electrical or electronic equipment at own or adjacent vehicles or nearby, and the control of disturbances from accessories that may be retrofitted to the vehicle; (c) Additional requirements for vehicles and ESAs providing coupling systems for charging the REESS regarding the control of emissions and immunity from this connection between vehicle and power grid.
WHICH VERSIONS OF ECE R10 ARE PUBLISHED?
Version of ECE R10 is mentioned as ECE R10Rev.6, ECE R10Rev.5 or ECE R10Rev.4. The latest version is Revision 6 and it has been officially published by UN ECE. On 30 October 2020, United Nations published an amendment for ECE R10 Rev.6. ECE R10 regulations and its amendments are free documents, you can download them by visiting official website of UN ECE. However, you can not reach test standards mentioned in the regulation since most of the test standards are not free of charge. If you need to check the details of standards you have to purchase them from web store of the standard publisher. Alternatively, you can ask Testups any technical questions about the tests.
WHAT ARE THE OTHER REGULATIONS PUBLISHED BY UN ECE?
ECE R10 is not the only regulation published by UN ECE. There are 160 regulations published by UN ECE. Each regulation specify requirements of the different types of vehicles or components that will be used on that vehicles.
DIFFERENT LANGUAGE VERSIONS OF ECE R10
There are three language options for ECE R10 regulation published by The United Nations Economic Commission for Europe (UNECE). You can click below links to reach English, French or Russian.
ECE R10 Rev 6 English
ECE R10 Rev 6 French
ECE R10 Rev 6 Russian
ECE R10 Rev 6 Deutsch is not available. However, you can get some general information about ECE regulations in German by clicking here.
ECE R10 TESTING
UN ECE R10 explains how to perform EMC tests and there are various test standards that are applied. Each test and test setup is explained in detail. UN ECE R10 EMC Tests can be categorized into two groups: emission and immunity. Emission and immunity tests are performed according to referred test standards. The standards referred to UN ECE R10 Revision 6 are listed below:
CISPR 12, CISPR 16-1-4, CISPR 25, ISO 7637-2, ISO-EN 17025, ISO 11451, ISO 11451-1, ISO 11451-2, ISO 11451-4, ISO 11452, ISO 11452-1, ISO 11452-2, ISO 11452-3, ISO 11452-4, ISO 11452-5, ITU Radio Regulations, edition 2008, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-3-11, IEC 61000-3-12, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-6-3, CISPR 16–2–1, CISPR 22, CISPR 16-1-2, IEC 61851-1 and CISPR 32.
What are immunity related functions?
ECE R10 mentions immunity related functions of the vehicle. This defines the test plan since products with immunity related functions need much more testing. “Immunity related functions” are listed as six function categories. This list is not exhaustive and shall be adapted to the technical evolution of vehicle or technology.
1) Functions related to the direct control of the vehicle:
By degradation or change in: e.g. engine, gear, brake, suspension, active steering, speed limitation devices;
By affecting drivers position: e.g. seat or steering wheel positioning;
By affecting driver’s visibility: e.g. dipped beam, windscreen wiper, indirect vision systems, blind spot systems.
2) Functions related to driver, passenger and other road user protection:
E.g. airbag and safety restraint systems, emergency calling systems;
3) Functions which, when disturbed, cause confusion to the driver or other road users:
Optical disturbances: incorrect operation of e.g. direction indicators, stop lamps, end outline marker lamps, rear position lamp, light bars for emergency system, wrong information from warning indicators, lamps or displays related to functions in subparagraphs (a) or (b) which might be observed in the direct view of the driver;
Acoustical disturbances: incorrect operation of e.g. anti-theft alarm, horn.
4) Functions related to vehicle data bus functionality:
By blocking data transmission on vehicle data bus-systems, which are used to transmit data, required to ensure the correct functioning of other immunity related functions.
5) Functions which when disturbed affect vehicle statutory data: e.g. tachograph, odometer;
6) Function related to charging mode when coupled to the power grid:
For vehicle test: by leading to unexpected vehicle motion;
For ESA test: by leading to an incorrect charging condition (e.g. over-current, over-voltage).
How to apply ECE R10 tests?
EMC tests are performed according to relevant clauses of ECE R10 regulation at EMC testing laboratories. EMC testing laboratories which are able to perform ECE R10 tests, are equipped with IEC, ISO or CISPR compliant EMC test chambers and equipments. Test experts check the product features and functions and make a test plan according to applicable ECE R10 EMC tests. Emission and immunity tests are performed. As Testups offers, ECE R10 tests can be finished in 4 weeks, if the product passes all product-specific EMC tests listed on the regulation and referred standards. After passing all applicable ECE R10 tests, test report is issued for the product (vehicle or ESA). This test report shows the ECE R10 test results of the product and it is required if the product also needs ”E-mark” or type approval according to UN ECE R10.
ECE R10 TYPE APPROVAL OR HOMOLOGATION
After ECE R10 tests are done and PASS test report issued, Type Approval or Homologation (E-marking) can be also issued for the product. In this step, ECE R10 test report, technical documents of the product and quality documents (like valid ISO 9001 certificate) of the manufacturing or/and distributor company are checked by a third party and authorized agency. They are also called designated technical service. If all product and company documents are submitted properly, E mark including a unique number can be affixed or labeled on the product.
Examples of approval marks
The below approval mark affixed to a vehicle or ESA shows that the vehicle type concerned has, with regard to electromagnetic compatibility, been approved in the Netherlands (E 4) pursuant to Regulation No. 10 under approval No. 05 2439. The approval number indicates that the approval was granted according to the requirements of Regulation No. 10 as amended by the 06 series of amendments.
Which countries are covered by ECE R10?
There are 57 countries which are under the scope of UN ECE Regulation 10. Each country has a ECE symbol and designated type approval authority. For instance for Ireland, ECE symbol is E24 and designated type approval authority is NSAI. For whole list of ECE R10 countries visit this page: ECE R10 Countries
COSTS FOR EMC TESTING AND TYPE APPROVAL
There are two cost item for ECE R10 compliance: testing and type approval.
What are the costs for ECE R10 EMC testing?
EMC testing costs depend on the features of the product, test plan, and location of test laboratory. If your product is a simple electronic sub assembly which has no immunity related function, reduced EMC tests are allowed. This will make costs lower. For such a simple product operating at a single voltage and with a single operation mode, ECE R10 testing costs will change in this range: 2.500 – 3.000 EUR.
What are the costs for ECE R10 Type Approval?
Type approval costs depend on the agency or country issuing the type approval. Although E1(Germany) and E24(Ireland) marks are technically identical, E1 marking takes some much more time and a bit expensive than E24 due to authorized agency costs. ECE R10 type approval (E marking) costs will change in this range: 1.500 – 2.000 EUR.
How to reduce ECE R10 testing costs ?
If you are suffering from the costs for ECE R10 testing and type approval, take into account suggestions listed below:
Check ECE R10 EMC tests during the design stage of your products. Early testing would save you time and money since you would have opportunity to get test results before serial production.
Use same or similar electronic components when designing your products. Using similar electronic components would increase the probability of the PASS ratio of test results. If you use various types of electronic components, ensure that they have been EMC tested or certified.
Group similar products in terms of electromagnetic compatibility and reduce number of model names with product family names. ECE R10 allows product grouping if technically applicable. When defining your product model names, try to group them under a product family model names.
Start testing with pre-compliance EMC tests during design validation stage of your products, this would save time and cost during ECE R10 certification. If an electronic product or vehicle never tested before, it would probably fail at one of ECE R10 tests. Pre-compliance testing would save you time and money even it seems causing extra costs.
Try to perform some EMC tests in house by having EMC test equipments (if you regularly need ECE R10 testing or type approval service). Work on investing on some of the EMC test instruments and prepare test setups which are most essential for your product. By in house testing, you would get opportunity to design your product more comfortable and to check your product’s EMC performance during its pilot or serial production.
Build a UN ECE R10 compliant EMC test laboratory (if you have various products that need ECE R10 testing or type approval service). UN ECE R10 compliant test laborotory needs some expert staff like test engineers and technicians. If your team can handle these laboratory operations, building a new test laboratory would make you much more comfortable in terms of electromagnetic compatibility of your products. If you would like go further, have accreditation or authorisation for your laboratory to show your lab’s independency and satisfy your customers.
Regulation No 10 of the Economic Commission for Europe of the United Nations (UN/ECE) — Uniform provisions concerning the approval of vehicles with regard to electromagnetic compatibility
ECE Regulation R10 of the Economic Commission for Europe of the United Nations (UN/ECE), the body responsible for implementing global trade agreements within Europe, addresses electromagnetic compatibility (EMC) issues and applying to vehicles of categories L, M, N O, T, R and S. The regulation requires manufacturers to gain type approval for all vehicles, electronic sub-assemblies, components and separate technical units.
ECE Regulation R10 covers the requirements regarding the immunity to radiated and conducted disturbances related to direct control of the vehicle, the driver, passenger and other road users’ protection. The regulation addresses disturbances which would cause confusion to the driver or other road users, related to vehicle data bus functionality. ECE Regulation R10 also addresses requirements regarding the control of unwanted radiated and conducted emissions to protect the intended use of electrical or electronic equipment from nearby or adjacent vehicles and the control of disturbances from accessories that may be retrofitted to the vehicle.
This page contains a list of European Commission decisions taken on the basis of formal objections raised against publication of the references of harmonised standards in the Official Journal of the European Union (OJEU).
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.
The references of harmonised standards must be published in the Official Journal of the European Union. The purpose of this website is to provide access to the latest lists of references of harmonised standards and other European standards published in the Official Journal of the European Union (OJEU).
References of harmonised standards and of other European standards published in the OJEU
Accessibility
Websites and mobile applications of public sector bodiesSearch for available translations of the preceding
Chemicals
Chemical substances (REACH)Search for available translations of the preceding
Explosives for civil usesSearch for available translations of the preceding
Pyrotechnic articlesSearch for available translations of the preceding
Conformity assessment and management systems
New Legislative Framework (NLF) and Eco-Management and Audit Scheme (EMAS)Search for available translations of the preceding
Construction
Construction products (CPD/CPR)Search for available translations of the preceding
Consumers and workers protection
Cosmetics productsSearch for available translations of the preceding
General product safetySearch for available translations of the preceding
Personal protective equipment (PPE)Search for available translations of the preceding
Toys safetySearch for available translations of the preceding
Energy efficiency
Ecodesign and energy labellingSearch for available translations of the preceding
Electric and electronic engineering
Electromagnetic compatibility (EMC)Search for available translations of the preceding
Equipment for explosive atmospheres (ATEX)Search for available translations of the preceding
Low Voltage (LVD)Search for available translations of the preceding
Radio Equipment (RED)Search for available translations of the preceding
Restriction of the use of certain hazardous substances (RoHS)Search for available translations of the preceding
Healthcare engineering
In vitro diagnostic medical devices (Regulation 2017/746)Search for available translations of the preceding
Medical devices (Regulation 2017/745)Search for available translations of the preceding
Active implantable medical devices (Directive 90/385/EEC)Search for available translations of the preceding
In vitro diagnostic medical devices (Directive 98/79/EC)Search for available translations of the preceding
Medical devices (Directive 93/42/EEC)Search for available translations of the preceding
Measuring technology
Measuring instruments (MID)Search for available translations of the preceding
Non-automatic weighing instruments (NAWI)Search for available translations of the preceding
Mechanical engineering and means of transport
Cableway installations designed to carry personsSearch for available translations of the preceding
Equipment for explosive atmospheres (ATEX)Search for available translations of the preceding
Gas appliances (GAR)Search for available translations of the preceding
Inspection of pesticide application equipmentSearch for available translations of the preceding
LiftsSearch for available translations of the preceding
Machinery (MD)Search for available translations of the preceding
Pressure equipment (PED)Search for available translations of the preceding
Rail system: interoperabilitySearch for available translations of the preceding
Recreational craft and personal watercraftSearch for available translations of the preceding
Simple Pressure Vessels (SPVD)Search for available translations of the preceding
Unmanned aircraft systems (UAS)Search for available translations of the preceding
Services
Community postal servicesSearch for available translations of the preceding
Sustainability
Packaging and packaging wasteSearch for available translations of the preceding
Use of harmonised standards
The use of these standards remains voluntary. Manufacturers, other economic operators, or conformity assessment bodiesSearch for available translations of the preceding linkEN••• are free to choose another technical solution to demonstrate compliance with the mandatory legal requirements.
Within the context of some directives or regulations, voluntary European standards supporting the implementation of legal requirements are not called “harmonised standards”. This legislation is also included in this information service if:
legislation foresees a need for a Commission standardisation request to European Standards Organisations;
publication of references in the Official Journal of the European Union is foreseen as a precondition for presumption of conformity or for other legal effect.
Official website ： https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
The Chinese national standard GB/T 17743-2021 was released and officially implemented in July 2022
On December 31, 2021, the National Standards Administration of the State Administration for Market Regulation issued the 2021 China National Standards Announcement No. 17. This announcement contains the recommended national standard GB/T 17743-2021 “Limits and Measurement Methods of Radio Disturbance Characteristics of Electrical Lighting and Similar Equipment”, which will be formally implemented on July 1, 2022.
Electric lighting and similar equipment involve a wide range in life and develop very rapidly, affecting the daily lives of thousands of households, city night lighting, entertainment stage lighting, and so on. GB/T 17743-2021 is equivalent to the IEC international standard CISPR 15:2018, which is an important test basis for electrical lighting and similar equipment in terms of emission harassment. The release of this standard marks that my country’s standardization work in this field is further in line with international standards, reduces trade barriers caused by technological differences, and will help enhance the competitiveness of my country’s related products in the international market.
You are welcome to consult us, please contact David Zeng info@emc.wiki or 1513888718@qq.com , We can provide one-stop testing, EMC debug and certification services.
信息技术设备、多媒体设备和接收机 电磁兼容 第2部分：抗扰度要求 Information technology equipment, multimedia equipment and receivers—Electromagnetic compatibility—Part 2: Immunity requirements
The national standard plan “Electromagnetic Compatibility of Information Technology Equipment, Multimedia Equipment and Receivers Part 2: Immunity Requirements” is reported under the jurisdiction of TC79 (National Radio Interference Standardization Technical Committee), TC79SC7 (National Radio Interference Standardization Technical Committee Information Technology Equipment, Multimedia Equipment and Receiver Electromagnetic Compatibility Branch), the competent authority is the National Standardization Management Committee. Proposed implementation date: officially implemented 6 months after the release.
The revision of this standard adopts the IEC international standard: CISPR 35:2016. Adopting standard Chinese name: electromagnetic compatibility and immunity requirements for multimedia equipment.
You are welcome to consult us, please contact David Zeng info@emc.wiki or 1513888718@qq.com , We can provide one-stop testing, EMC debug and certification services.
The United States FCC SDOC refers to Supplier’s Declaration of Conformity, or Supplier’s Declaration of Conformity, or SDoC for short. The equipment supplier (note: the supplier must be a local company in the United States) will test the equipment that meets the specified standards or requirements, and the equipment that meets the regulations must provide relevant documents (such as SDoC declaration documents) to provide proof to the public. The SDoC policy simplifies the previously complicated FCC certification requirements and further reduces the burden on enterprises.
FCC SDOC
SDOC certification means that all electronic and electrical products going to the United States need to comply with FCC PART 15B of the United States, that is, all previous electronic and electrical products that comply with FCC VoC and FCC DoC.
FCC SDoC changes
There are clear requirements for the person in charge of the product, and the contact information of the U.S. company needs to be provided. The responsible party can be the importer or consignee or customs broker. At the same time, after November 2, 2018, the FCC DOC and FCC VOC will be invalid;
All SDoC products can independently choose whether to mark the FCC Logo;
The authentication methods of our common equipment have undergone major changes. Except for wireless transmission products/scanning receivers/power line broadband access/radar detection products, FCC ID must be made, and all other products can choose FCC ID or SDOC.
SDoC product range
In applying for FCC certification, FCC SDoC applies to ordinary products without wireless functions, such as displays, ordinary household appliances, lamps, etc. Including personal computers and peripheral equipment; household appliances; electric tools; audio and video products; lamps; toys; security products, etc. Such as monitors, mice, refrigerators, electric kettles, hair dryers, LED lamps, electronic toys, ordinary access control and other products.
FCC Class A or B
§ 15.3 Definitions.
(h) Class A digital device. A digital device that is marketed for use in a commercial,industrial or business environment,exclusive of a device which is marketed for use by the general publicor is intended to be used in the home.
(i) Class B digital device. A digital device that is marketed for use in a residential environment notwithstanding use in commercial, business and industrial environments. Examples of such devices include, but are not limited to, personal computers, calculators, and similar electronic devices that are marketed for use by the general public.
NOTE: The responsible party may also qualify a device intended to be marketed in a commercial, business or industrial environment as a Class B device, and in fact is encouraged to do so, provided the device complies with the technical specifications for a Class B digital device. In the event that a particular type of device has been found to repeatedly cause harmful interference to radio communications, the Commission may classify such a digital device as a Class B digital device, regardless of its intended use.
FCC SDOC conducted emission limit
§15.107 Conducted limits.
(a) Except for Class A digital devices, for equipment that is designed to be connected to the public utility (AC) power line, the radio frequency voltage that is conducted back onto the AC power line on any frequency or frequencies within the band 150 kHz to 30 MHz shall not exceed the limits in the following table, as measured using a 50 μH/50 ohms line impedance stabilization network (LISN). Compliance with the provisions of this paragraph shall be based on the measurement of the radio frequency voltage between each power line and ground at the power terminal. The lower limit applies at the band edges.
Frequency of emission (MHz)
Conducted limit (dBμV)
Conducted limit (dBμV)
Quasi-peak
Average
0.15-0.5
66 to 56*
56 to 46*
0.5-5
56
46
5-30
60
50
(b) For a Class A digital device that is designed to be connected to the public utility (AC) power line, the radio frequency voltage that is conducted back onto the AC power line on any frequency or frequencies within the band 150 kHz to 30 MHz shall not exceed the limits in the following table, as measured using a 50 μH/50 ohms LISN. Compliance with the provisions of this paragraph shall be based on the measurement of the radio frequency voltage between each power line and ground at the power terminal. The lower limit applies at the boundary between the frequency ranges.
Frequency of emission (MHz)
Conducted limit (dBμV)
Conducted limit (dBμV)
Quasi-peak
Average
0.15-0.5
79
66
0.5-30
73
60
FCC SDOC Radiation Test Limit Request
§15.109 Radiated emission limits.
(a) Except for Class A digital devices, the field strength of radiated emissions from unintentional radiators at a distance of 3 meters shall not exceed the following values:
Frequency of emission (MHz)
Field strength (microvolts/meter)
30-88
100
88-216
150
216-960
200
Above 960
500
(b) The field strength of radiated emissions from a Class A digital device, as determined at a distance of 10 meters, shall not exceed the following:
Frequency of emission (MHz)
Field strength (microvolts/meter)
30-88
90
88-216
150
216-960
210
Above 960
300
Typical question and answer
Should the lighting products be grade A or grade B? Answer: According to the standard lamps, if they are installed in the home, they must meet the B-level limit requirements. If they are installed in outdoor or industrial environments, they can use the A-level limit requirements.
Is FCC Part 15 Grade B easy to pass, or is FCC Part 15 Grade A easy to pass? Answer: According to the limits stipulated in the standard, the limit of Class A is significantly higher than the limit of Class B, which means that Class A is easier to pass in the case of the same sample.
Can FCC test data of A and B levels be interchangeable? If the data is tested to level B, if level B does not meet the requirements, can it be replaced with level A? Answer: Of course, it can be interchanged. The data will not change. Only the limit value is changed. Generally, the test software can easily exchange the A-level and B-level limits. Please confirm and communicate with the test engineer. For example, if you are taller than Yao Ming and taller than Zhangwei, your height remains the same, and what you change is just a reference.
You are welcome to consult us, please contact David Zeng info@emc.wiki or 1513888718@qq.com , We can provide one-stop testing, EMC debug and certification services.
FCC ID refers to the FCC wireless certification in the United States. After passing the certification, a string of numbers will appear, commonly known as FCC ID certification.
FCC ID products include
Wireless radio frequency products, such as BT, Wifi, Zigbee, 2.4GHz, 5GHz, mobile phone products, various remote controls and other intentional launch products, all need to comply with the US FCC PART 15C standard limit.
Verification method
The product needs to pass the FCC approved test lab with the test is completed and the test report is obtained.
Organize product technical information, including: product details photos, block diagrams, circuit schematics, operational description, user manuals, etc.
Then the NVLAP & A2LA test laboratory approved by the FCC will submit it to the FCC TCB test room to confirm that all the information is correct (or directly find the TCB), and issue a certificate.
FCC ID standard
FCC ID 47 CFR PART 15 Subpart C: 2019 section 15.247 (not 5g wifi)
ANSI C63.10: 2013
Coverage frequency
FCC Rules and Regulations Part 15 Subpart C Section 15.247-2.4G WIFI / BT
FCC Rules and Regulations Part 15 Subpart C Section 15.407-5.2G WiFi
FCC Rules and Regulations Part 15 Subpart C Section 15.407-5.8G WiFi
For MIMO system of 802.11n/ac, total power is calculated by combining the output power of each antenna according to KDB662911
North America 2.4G BT
2402-2480 MHz
GFSK, π/4-DQPSK, 8DPSK for Bluetooth (DSS)
GFSK for Bluetooth (DTS)
79 channels for Bluetooth (DSS)
40 channels for Bluetooth (DTS)
North America2.4G WIFI
2412MHz ~ 2462MHz
802.11b: DSSS; 802.11g/n: OFDM
11 Channel for 20MHz bandwidth(2412~2462MHz)
7 channels for 40MHz bandwidth(2422~2452MHz)
North America 5G WIFI frequency band
5150 MHz ~ 5250 MHz
5725 MHz ~ 5850MHz
FCC Part 15.407: Unlicensed National Information Infrastructure (U-NII)
North America 5.2G WIFI
FCC Rules and Regulations Part 15 Subpart C Section 15.407
ANSI C63.10: 2013
4 channels for 5180 MHz ~ 5240 MHz (802.11a/n/ac-HT20);
2 channels for 5190 MHz ~ 5230 MHz (802.11n/ac-HT40);
1 channel for 5210 MHz (802.11ac-HT80);
North America 5.8G WIFI
FCC Rules and Regulations Part 15 Subpart C Section 15.407 ANSI C63.10: 2013
5 channels for 5745 MHz ~ 5825 MHz (802.11a/n/ac-HT20);
2 channels for 5755 MHz ~ 5795 MHz (802.11n/ac-HT40);
1 channel for 5775 MHz (802.11ac-HT80);
North American DFS Band
If you have a device that supports WIFI 802.11a, you need to evaluate DFS, which includes Master active such as a router, and Slave passive such as a mobile phone.
5.250–5.350 GHz, whether it is used indoors or outdoors, should be operated according to dynamic frequency selection (DFS or avoid radar). The regulations allow users to install antennas with a power limit of 250 mW.
5.470-5.725 GHz, whether it is used indoors or outdoors, should be operated according to dynamic frequency selection (DFS or avoid radar).
FCC ID certification sample preparation
Provide at least 1~2 prototypes required to apply for FCC ID, one complete and ordinary similar shipment sample, and one RF fixed-frequency prototype.
You are welcome to consult us, please contact David Zeng info@emc.wiki or 1513888718@qq.com , We can provide one-stop testing, rectification and certification services.
We can provide customers with CE certification for various electronic and electrical products.
Not limited to Electromagnetic compatibility (EMC) DIRECTIVE 2014/30/EU, Radio Equipment (RED) Directive 2014/53/EU，Low Voltage (LVD) Directive 2014/35/EU，Restriction of the use of certain hazardous substances (RoHS) Directive 2011/65/EU.
EN IEC 61000-3-2:2019 EN 61000-3-3:2013/A1:2019 EN 55032:2015/A11:2020 EN 55035:2017 or EN 55024:2010/A1:2015
Home appliances EMC standards
EN IEC 61000-3-2:2019 EN 61000-3-3:2013/A1:2019 EN 55014-1:2017 EN 55014-2-2015
Lamps EMC standard
EN IEC 61000-3-2:2019 EN 61000-3-3:2013/A1:2019 EN 55015:2013+A1:2015 EN 61547:2009
RED – Radio Equipment – Directive 2014/53/EU
For Bluetooth wireless products, what standards are required for European wireless RED certification?
RF (intentionally radiated radio frequency part)
EN 300328 V2.2.2
EN 301489-1 V2.2.3
EN 301489-17 V3.2.2
EMC (Unintentional emission part, according to different products, different product standards are used, the following is an example of Bluetooth speakers)
EN IEC 61000-3-2:2019
EN 61000-3-3:2013/A1:2019
EN 55032:2015/A11:2020
EN 55035:2017 or EN 55024:2010/A1:2015
LVD (Low Voltage Directive, choose one of the following two)
EN 62368-1:2014+A11:2017
or
EN 60950
EMF
EN 62479：2010
European WIFI test standard
RED Radio Frequency RF Standard
EN 300328 V2.2.2(For 2.4GHz)
ETSI EN 301 893 V2.1.1(For 5GHz)
EN 301489-1 V2.2.3
EN 301489-17 V3.2.2
If it is embedded in a certain type of product, it needs to meet the corresponding product standards. For example, multimedia products need to meet:
EMC standards
EN IEC 61000-3-2:2019
EN 61000-3-3:2013/A1:2019
EN 55032:2015/A11:2020
EN 55035:2017 or EN 55024:2010/A1:2015
There are also safety standards corresponding to the LVD directive. For example, multimedia products need to meet: EN 62368-1
LVD (Low Voltage Directive, choose one of the following two)
EN 62368-1:2014+A11:2017
EN 60950
EMF
EN IEC 62311:2020
You are welcome to consult us, please contact David Zeng info@emc.wiki or 1513888718@qq.com , We can provide one-stop testing, rectification and certification services.
We can provide customers with EMC of various electronic and electrical products debug services.
For example, the product radiated emission exceeds the standard limit, the conducted emission exceeds the standard limit, the ESD anti-interference does not meet the standard requirements, the RS radiation anti-interference does not meet the standard requirements, the surge immunity does not meet the standard requirements, and the CS conduction immunity does not meet the standard requirements. Meet the standard requirements, etc. We can all help customers to debug, for example, add lc filtering on pcb, change capacitance, inductance parameter value, pcb trace for wire cutting and jumper, cable shielding, adding EMI magnetic ring, etc.
EMI debugEMC debugEMI and EMS DebugMeeting to study EMC issues
You are welcome to consult us, please contact David Zeng info@emc.wiki or 1513888718@qq.com , We can provide one-stop testing, EMC debug and certification services.
