In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems.
The complete standard is recognized with the following exception:
In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced by RF fields” (4th Row) is not recognized.
Starting on April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007 or ANSI/AAMI/IEC 60601-1-2:2007. This recognition affects all electrical medical devices, except for active implanted devices.
However, a new FDA publication “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now (not 2017!) to cover test levels which may not be properly addressed in the 3rd edition.
Some of the changes to the 4th edition from the 3rd edition of IEC 60601-1-2 are:
- With regards to electromagnetic environments, the “life supporting equipment” category has been removed
- CISPR 15 has been removed as an option for lighting features, replaced by CISPR 11
- ESD test levels were increased for both air and contact type discharges
- RF susceptibility test levels are now specified based on the intended use environment
- Transient tests on DC input power ports in accordance with ISO 7637-2 have been added
- New conducted RF disturbances requirements are based on location of intended use
- Test levels for power frequency magnetic fields increased tenfold, to 30 A/m
- Testing is now at multiple phase angles for the half-cycle, 100% voltage dip
There are many other changes in the 4th edition, contact MET Labs to schedule a new product discovery or existing product ‘gap analysis.’
MET is a leading independent test lab for medical equipment approvals for product safety, EMC and performance. Learn more about Medical Compliance Testing.
Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews.
- IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes
- EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation of Lab, Test & Measurement Equipment
- EN55032 Replacing EN55022 and Others for CE Marking of Multimedia Equipment
- New Radio Equipment Directive Adopted by EU, Awaits Publication in OJ
- CE Marking Directives Recast to Align with New Legislative Framework
- IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets
- Some Electronic Devices Are Exempt from FCC EMC Testing
- Top 20 Non-Compliance Findings for Panel & Motor-Operated Equipment
- EMI/EMC Testing Best Practices – Before & During Your Lab Visit
- Radio Equipment Directive (RED) Replacing R&TTE Directive, is Published in OJ
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Want more in-depth information on one of these topics? Check to see if we are planning a seminar or webinar on it.
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In the first half of 2014, the European Union’s EMC Administrative Cooperation Working Group (EMC ADCO) performed a cross-border EMC market surveillance campaign to assess the compliance of grid-connected solar panel inverters (and optimisers) intended to be used by consumers. Inverters allow electricity generated by solar photovoltaic (PV) modules to be fed into the mains electrical supply of a building, or directly into the public electricity grid.
The primary purpose of the campaign was to assess the compliance of inverter samples randomly taken from the market, with the provisions of the EMC Directive (EMCD). EMC ADCO is not a regulatory body, so there were no penalties assessed as a result of non-compliance.
Fifty-five products were assessed between January 1, 2014 and the 30th June 2014. In general, the level of compliance with the administrative and technical requirements was considered very low. Overall, only 9% of the Equipment Under Test (EUT) were assessed as compliant.
The results of the assessment of EUT showed:
- Approximately a third (38%) were administratively compliant (related to CE mark use and Declarations of Conformity)
- A third (33%) were technically compliant with an applicable harmonized standard
For emissions, 38% were compliant to EN 55011 Table 8 limits at mains terminals in the frequency range 9 kHz-150 kHz. For the DC side (optional), 43% were compliant to EN 61000-6-3 emission requirements to the DC power port. Immunity aspects were not assessed.
Fourteen European countries participated in the campaign. The majority of EUT – 58 % – were of EU/EFTA origin.
EMC ADCO concluded: “The EUT represented a large sample of the products available on the market and it is clear that much remains to be done by manufacturers in terms of compliance.”
MET Labs is a leading 3rd party evaluator of inverters for Europe, North America, and Asia. Contact us today for a free quote for inverter testing and certification for product safety and/or electromagnetic compatibility (including anti-islanding).
On October 16, 2014 the FCC published 726920 D01 Confidentiality Request Procedures, a new document that details the steps required to ensure proprietary information about your device will be held confidential.
To be granted confidentiality, your application must include a reference to 0.457(d) and 0.459 of the FCC Rules, the reason why the information should be held from the public, specific confidential information by exhibit type, name, and description, an indication if the information is a “trade secret,” a signature, and the type of confidentiality requested. Confidentiality Letters must specifically reference the documents you wish to withhold from the public.
The two types of confidentiality are long term and short term.
Under long term confidentiality, the following exhibits are held private without filing a request:
- Software defined radio, cognitive radio attachments submitted into the SDR software, security info exhibit type
- Scanning receiver information included in one of the exhibits noted as “commonly held confidential” and scanning receiver internal photos
Under long term confidentiality, the following exhibits can be held private upon request:
- Block diagrams
- Operational descriptions
- Parts list/tune up info
Under short term confidentiality, exhibits held private are the same as long term confidentiality, plus:
- External photos
- Test set up photos
- Internal photos
- User manuals
Short term confidentiality can only last up to 180 days. If you request short term confidentiality but market your device before the 180 day period is over, you must notify your Telecommunication Certification Body (TCB) so your confidentiality request can be removed.
If you are seeking confidentiality for an exhibit not listed above, you are able to petition the FCC and all approvals are made on a case-by-case basis.
Read about how Some Electronic Devices Are Exempt from FCC EMC Testing.
Most electrical/electronic designs today are subject to electromagnetic interference/electromagnetic compatibility (EMI/EMC) testing.
The first step is to write a test plan. If you are working in the defense industry, a military test plan is usually a contract requirement. If not, you’ll still want one. If you don’t know enough to create one, ask your lab to do it, or to recommend an independent consultant who can help.
A good test plan includes:
- A configuration, mode of operation, and monitoring method, which represents a worst case scenario from an EMC perspective
- Special software, test fixtures, and supporting equipment may be needed to exercise the equipment under test
- A description of hardware to be tested, including peripherals & I/O configurations
- An indication of which external power and data I/O ports need to be tested for each test method
- Required tests
- A definition of failure criteria
- How to monitor, recognize & report failures
- Special needs: Software, power, cooling, etc.
Then, get pricing and scheduling from a leading 3rd party test lab, like MET Labs.
You’ll have to determine what the lab will supply versus what you will supply. You will need:
- Equipment under test (EUT) & spares
- Cables & connectors
- Test fixture (for some programs)
- Tool kit
- EMI suppression supplies – ferrites, copper tape, etc.
- The equipment’s design or compliance engineer or someone else familiar with the product to witness testing
In the Lab
Preliminary testing (pre-testing) is always a good idea. Shortened versions of each test method can be performed to identify failures. Design modifications can be made before final testing is scheduled. A radiated emissions pre-test, often referred to as a pre-scan, is the most common pre-test performed. Even if there is no plan to perform pre-testing for the other test methods, a radiated emissions pre-scan can identify failures and allow for design modifications, which will likely cause the equipment under test to perform better for the other test methods as well.
Then run the full program as specified in the test plan. If you pass the first time, congratulations! If not, don’t take it personally – it’s not unusual, especially with early-stage pre-compliance testing. And practically anything can be overcome.
If you fail a test, do some quick troubleshooting – you may be able to fix the problem right away. Do the easy things first:
- Verify that the EUT is still working properly. This is particularly important with immunity tests that might cause damage.
- Unplug external cables to see if it improves results. External cables, although not designed to do so, act as antennas to radiate emissions and receive RF interference.
- Add ferrites to cables
- Clean mating, conductive surfaces of paint and other materials.
- Add an RF filter module at the power input to the equipment under test to limit RF emissions and protect from continuous conducted disturbances.
- Add a MOVs or other transient limiting device at the power input to protect from transient disturbances.
- To limit leakage, wrap the EUT in aluminum foil
For immunity, back off the test levels to determine the actual failure levels. If you are close, maybe a ferrite will fix things. If not, that’s good information to have – it will help you narrow the possible failure mechanisms.
Don’t be afraid to ask for suggestions. Test engineers at an experienced lab like MET will have seen hundreds if not thousands of products, and know many debug and quick-fix solutions.
MET Labs is a full-service EMC testing lab with multiple convenient locations. Contact us for a free quick-response quotation.
Most electronic devices destined for sale in the U.S. fall under Part 15 (CFR 47) of the Federal Communications Commission (FCC) rules for limits to the unintentional and intentional emission of radiation. However, there are some exemptions that you may be able to take advantage of, depending on the nature of your product. You can find the bulk of this information in Section 15.103 of the rules.
The FCC says it is “strongly recommended” that you still attempt to comply with the rules, regardless of your product type. They have the power to halt sales of your device if the device has been found to cause harmful interference, so proceed with caution.
Here is a simplified description of product types that are FCC exempt from digital emissions testing:
- A digital device utilized exclusively in any transportation vehicle including motor vehicles and aircraft. Note: wireless devices are subject to other FCC rules.
- A digital device used exclusively as an electronic control or power system utilized by a public utility or in an industrial plant.
- A digital device used exclusively as industrial, commercial, or medical test equipment.
- A digital device utilized exclusively in an appliance, e.g., microwave oven, dishwasher, clothes dryer, air conditioner, etc.
- Specialized medical digital devices (generally used under the supervision of a licensed health care practitioner) whether used in a patient’s home or a health care facility.
- Digital devices that have a power consumption not exceeding 6 nW.
- Joystick controllers or similar devices, such as a mouse, used with digital devices but which contain only non-digital circuitry or a simple circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital conversion).
- Digital devices in which both the highest frequency generated and the highest frequency used are less than 1.705 MHz and which do not operate from the AC power lines. Digital devices that include battery eliminators, AC adaptors or battery chargers which permit operation while charging or that connect to the AC power lines indirectly do not fall under this exemption.
Although not noted in section 15.103, equipment authorization is also not required for:
- Personal use home-built devices (not kit-constructed) that are assembled in quantities of five or less
- Low-frequency devices that don’t generate timing signals or pulses at a rate in excess of 9,000 pulses (cycles) per second (i.e., 9 kHz)
Note that equipment is not exempt unless all of the devices in the equipment meet the criteria for exemption. For example, if you have a specialized medical digital device with a wireless transmitter, the wireless transmitter still has to be tested.
Please confirm with MET Labs whether you are indeed exempt as there are some caveats to this information.
And, of course, FCC-exempt devices might be required to undergo other types of testing, like product safety certification for U.S. OSHA compliance or EMC testing for CE marking in Europe. Contact MET for a full evaluation of your product line and its intended markets.
In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements.
For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition). The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance.
Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016. It’s typically 3 years before accepted standards are required for new submittals.
In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe. There is no grandfathering in Europe.
Following are some of the key changes in the 4th edition.
Use environments are split into three areas:
- Professional Healthcare Facility Environment
- Home Healthcare Environment
- Special Environment (test levels specified in Annex E)
Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker. The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.
For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.
For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.
Immunity test levels increase:
- The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
- Magnetic immunity at 30A/m
- Conducted immunity at 6V in ISM bands
- ESD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
- Voltage dips and interruptions at additional phase angles
In addition to these Immunity changes:
- Immunity levels (Table 9) are harmonized with IEC 60601-1-11
- Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
- Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
- There is a procedure for continuing to test a product that is damaged by an immunity test signal
And Risk Management is expanded:
- Manufacturers will be required to submit a test plan and the risk analysis document before testing
- Operating modes are based on risk analysis
- Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
- The risk management process is used to determine whether subsystem testing is allowed
- The minimum separation distance are considered in the risk management process
- Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file
Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.
To sell most types of electrical or electronic products in the European Union (EU), electromagnetic compatibility compliance with EMC Directive 2004/108/EC is required.
To meet the essential requirements of the EMC Directive, testing to a particular standard or standards is voluntary, although recommended, as they can provide a presumption of conformity. Harmonized standards are featured in The Official Journal of the European Union (OJ). Each standard governs a particular type of equipment, such as laboratory, IT, or household. The standards determine the strength and the limits for tests used to evaluate the product. Engineers should use generic standards only when there is no family standard covering the product.
If a product is redesigned or if the standard expires, manufacturers can perform a gap analysis to see if the product needs to be re-tested. If not, the manufacturer can prepare documentation with justifications, explaining why re-testing is not necessary.
The directive requires all possible product configurations be included in the EMC assessment, although a worst case representative model may be sufficient to cover simpler versions. If the difference is not design-related, such as a product color or shape, this model can be excluded from the list.
A company needs to prepare technical documentation or declaration of conformity (DoC) in accordance with Annex IV. The file should include a general description, environments where it can be used, warnings, manuals, and test reports.
The following standards are a good reference on how to prepare a DoC: EN ISO/IEC 17050-1:2005 and EN ISO/IEC 17050-2:2005. CENELEC has also published a specific guide for the DoC: CENELEC Guide 16.
The directive requires manufacturers or their authorized representatives to hold the technical documentation for at least 10 years after the last manufacturing date.
To ensure that products are tested to the correct standards and are in full compliance, manufacturers might want to submit their technical file and EMC report to a Notified Body (NB) for review. If everything is in order and complete, it issues a statement of opinion to be included in the technical file.
MET Labs has been designated a Conformity Assessment Body (CAB) in accordance with the US-EU mutual recognition agreement. For the EMC and R&TTE Directives, MET can prepare Technical Construction Files and perform other Notified and Competent Body functions.
If a manufacturer tries to place a non-compliant product on the EU market, it could face penalties that range from removing the product from the market to liability for a fine and/or imprisonment.
Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical
devices. The guidance is recommended, but not mandatory.
FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.
The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).
The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said.
FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.
FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.
IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.
EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).
FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.
MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference. Find out more about the Program.
MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU. Register here.
China is fast becoming the largest consumer market in the world, and for many products, China Compulsory Certification (CCC) is necessary for manufacturers to tap this market.
There are three main certification bodies (CBs) for electronic equipment:
- China Quality Certification Center (CQC) – issues all electronic equipment CCC certificates
- China Information Security Certification Center (ISCCC) – issues ITE CCC certificates
- China Electronics Standardization Institute (CESI) – issues A/V CCC certificates
An application is submitted to one of the certification bodies mentioned above. Once the application is accepted, the manufacturer has samples tested at an accredited lab in China. When the product passes, the test report is issued by the test lab and reviewed by the certification body. If the CB is satisfied with the test report and the manufacturer passes an initial factory inspection, the report will be approved and the CCC certificate will be released.
The CCC certificate is generally valid for five years and requires follow-up inspections that verify quality control and product consistency.
CCC certification is to Chinese national standards called Guobiao or GB standards. Usually the GB standard is harmonized to an IEC standard. For example for ITE, GB4943 is harmonized to IEC60950 for product safety; GB17625 (updated to GB17625.1-2012 on July 1, 2013) is harmonized to IEC61000-3-2 and GB9254 is harmonized to IEC/CISPR 22 for electromagnetic compatibility. There are some minor national deviations like ratings, altitude or tropical zone requirements. (Read more about recent changes to GB8898 Audio, Video and Similar Electronic Apparatus – Safety Requirements and GB4943.1 Safety of Information Technology Equipment.)
Generally, if you can pass the IEC standard, you should be OK to pass the CCC test. Manufacturers can save time and reduce cost by transferring a CB report to a CCC report.
MET Labs has experience helping manufacturers obtain CCC certification. MET’s China operations are based in Shenzhen, Guangdong Province. Contact MET China or MET U.S. for more information about CCC certification.