Wireless & Telecom Regulatory Compliance for Top 5 African Economies

by on Nov.23, 2015, under Wireless

This africa-flag-mappost is an overview of the wireless and telecom compliance requirements for the 5 largest population countries in Africa.  As with any electrical product compliance issue, regulations can change rapidly, so check in with MET’s Global Market Access Group for the latest requirements.

The most populous country in Africa, Nigeria accepts EU R&TTE Directive reports and CE Declarations of Conformity (DoCs) as proof of compliance.

  • Required: Local company representative, regulatory marking
  • Not required: Product test samples

Certificates have no expiration date, but they must be updated if the approved product is modified.

The Nigerian Communications Commission (NCC) website is available in English.  It lists what categories of telecom and wireless technologies are affected.

The 2nd most populous country in Africa, Ethiopia accepts FCC grants and test reports or EU R&TTE Directive reports and CE DoCs as proof of compliance.

  • Not required: Product test samples, local company representative, and regulatory marking

Certificates have no expiration date, but they must be updated if the approved product is modified.

The Ministry of Communication and Information Technology (MCIT) website is available in English.  It lists what categories of telecom and wireless technologies are affected.

The 3rd most populous country in Africa, Egypt has compliance requirements for EMC, health and safety, wireless, and telecom.  The National Telecommunication Regulatory Authority (NTRA) accepts EU R&TTE Directive reports as proof of compliance.

  • Required: Product test samples (telecom only)
  • Not required: Local company representative

Certificates have no expiration date, but they must be updated if the approved product’s critical components are modified.

The NTRA website is available in English.  It includes information on type approvals and categories of products covered.

Democratic Republic of the Congo (DRC)
The 4th most populous country in Africa, DRC accepts FCC grants and test reports or EU R&TTE Directive reports as proof of compliance.

  • Required: Local company representative
  • Not required: Product test samples, regulatory marking

Certificates are valid for 10 years, assuming no change to the product.

The Congolese Post and Telecommunications Agency website is in French only and has limited information.

Note: The U.S. government places some restrictions on certain ‘dual-use’ (military and non-military application) technologies for export to DRC.

South Africa
The 5th most populous country in Africa, South Africa accepts FCC grants and test reports or EU R&TTE Directive reports and CE DoCs as proof of compliance.

  • Required: Local company representative, regulatory marking
  • Not required: Product test samples

Certificates have no expiration date, but they must be updated if the approved product is modified.

The Independent Commissions Authority of South Africa (ICASA) website is available in English.  It provides information on relevant regulations and certification programs.

Our dedicated Homologations Team and extensive network of international labs can help you get your products certified in over 65 countries.  Contact Us today for a free quotation or to ask a question.

To learn more about gaining approvals to sell your product around the world, register for a free webinar on Global Market Access.

1 Comment :, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , more...

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

by on Nov.18, 2015, under EMC, Medical

The U.S. me-300x240Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device, as well as the use of appropriate FDA-recognized standards.

EMC as defined by FDA includes immunity to electromagnetic disturbance (interference), and being free of excessive electromagnetic disturbances (emissions) that might interfere with other devices.

In premarket submissions, manufacturers of electrically-powered medical devices typically reference IEC 60601-1-2 (read about the new 4th edition here) or the equivalent U.S. version. In addition, there are device-specific consensus standards, or “particular” standards (e.g., IEC 60601-2-X, where X denotes a particular device standard). These particular standards may augment or supersede the requirements in the IEC 60601-1-2 standard. There are also other consensus standards for electrically-powered medical devices that include information on EMC (e.g., ISO 147083 for active implantable devices).

According to FDA’s guidance, a claim of EMC for a device should be accompanied by this information:

  • Summary of the testing that was performed to support EMC
  • The specifications of the standard that were met
  • The device-specific pass/fail criteria used
  • The specific functions of the device that were tested (including essential performance) and how these functions were monitored
  • The performance of the device during each test
  • An identification of and a justification for any of the standard’s allowances that were used
  • A description of and justification for any deviations from the specifications of the referenced standard
  • The device labeling and evidence of compliance with the reference standard’s labeling specifications
  • A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests.

FDA will accept written or electronic comments and suggestions on this draft through mid-December.  Submit electronic comments to http://www.regulations.gov

FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Have questions about this guidance, or any other electro-medical device regulatory issue?  Ask Pat, our compliance expert.  Pat (and MET) have been skillfully performing medical product testing and certification for decades.

Leave a Comment :, , , , , , , , , , , , , , , more...

Inductive Wireless Charging Products Must Comply with These Emissions & SAR Requirements

by on Nov.11, 2015, under Wireless

power.480Manufacturers of new technologies often struggle to determine what electrical compliance regulations apply to their products.  Here is a basic guide for inductive wireless power products, like the wireless mobile phone chargers that are gaining more market penetration.

This post is derived from an Intel Corporation presentation given at the recent FCC TCB Council Workshop in Baltimore, MD.  As a leading FCC TCB, MET Labs attends this workshop annually.

With the merger last week of the Alliance for Wireless Power and the Power Matters Alliance into the new AirFuel Alliance, the inductive wireless power product industry has been reduced to two competing technologies. (Wireless Power Consortium, owner of the Qi wireless standard, controls the other one).  These two technologies sometimes vary in their compliance requirements, as noted below.

Emissions: 6.78 MHz Emissions: 100-400 KHz RF Exposure (SAR)
United States FCC Part 18 FCC Part 15C or Part 18 FCC Part 1.1310
Canada RSS 216 RSS 216, RSS gen or RSS 210 RSS 102
Europe EN 55011 EN 300 330 or EN 55011 1999/519/EC, ICNIRP
China MIIT No. 423, Type C MIIT No. 423, Type A or D No
Korea RRA Notice 2013-9 RRA Notice 2013-9 FCC Part 1.1310
Japan In development In development ICNIRP


In many of these markets, standards and regulations are in transition, so contact MET to determine the latest requirements.

Leave a Comment :, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , more...

Global Electricity Meter Sales Will Accelerate in 2016

by on Oct.29, 2015, under Meters

Global electricity meter sales (excluding China) will exceed 173 million units in 2015, accelerate in 2016 and hit a 22% increase by 2020, according to a report by UK-based research firm Statplan.

According to the company, 99% of global electricity meter stocks were electromechanical in 1985, declining to 66% this year.  By 2020, it is expected to decrease to 44%, as utilities replace legacy meters with prepayment and smart metering systems.

The report forecasts an increase in the global sales of low
DSC_0097-voltage (LV) smart meters from the current 35.4% to 45.7% in 2020.

Prepayment meter sales – for use where electricity theft is common – will rise from 11.2% in 2015 to 14.9% in 2020

According to a September Market Forecast report from Northeast Group, smart meter sales are growing especially fast in Mexico.  The country has recently issued a number of tenders for installation of smart meters, with vendors being shortlisted for the supply of 30.2 million smart meters from 2015-2025.

In parallel with this activity, recent Mexico CFE meter standards revisions have transitioned toward general harmonization with IEC requirements:

  • CFE G0100-05 (April 2015) – Advanced Metering Infrastructure System (AMI)
  • CFE GWH00-09 (January 2015) – Interactive System Infrastructure and Measuring Electricity

The Mexican movement toward IEC requirements is a drift away from U.S. standards, which rely on ANSI C12.1 and C12.20.

Meter manufacturers rely on MET Labs for the meter approvals they need to sell in different markets around the world, including Mexico and the U.S.

Utilities rely on MET Labs for an objective independent assessment of meter failures in the field, or meters they are considering for purchase.

To find out more about MET’s #1 meter certification program, contact us today.

Leave a Comment :, , , , , , , , , , , , , , , , , , , , , more...

Top 3 Standards for Lithium Battery Safety Testing

by on Oct.19, 2015, under Battery

For small liLi_ion_laptop_batterythium batteries, there are three standards that our Battery Lab tests to most often:

  • UN/DOT 38.3 5th Edition, Amendment 1 – Recommendations on the Transport of Dangerous Goods
  • IEC 62133 2nd Edition – Rechargeable Cell/Battery Safety
  • UL 2054 2nd Edition – Household and Commercial Batteries

Following is a quick overview of each one.

UN/DOT 38.3
Want to ship a lithium battery almost anywhere in the world by air, vessel, rail, or truck?  Unless you want to be extremely restricted in your options for transporting your batteries (ground transport as Class 9 Hazardous Goods), you will need to certify that your batteries have passed UN/DOT 38.3.

Found in many countries’ shipment of dangerous goods regulations, this standard is relevant for the transportation safety of all lithium metal and lithium ion cells and batteries

UN/DOT 38.3 is a self-certify standard but because of potential liability issues, most companies choose to use a third party test lab like MET Labs.

UN 38.3 presents a combination of significant environmental, mechanical, and electrical stresses, in sequence (T1-T5):

  • T1 – Altitude Simulation (Primary and Secondary Cells and Batteries)
  • T2 – Thermal Test (Primary and Secondary Cells and Batteries)
  • T3 – Vibration (Primary and Secondary Cells and Batteries)
  • T4 – Shock (Primary and Secondary Cells and Batteries)
  • T5 – External Short Circuit (Primary and Secondary Cells and Batteries)
  • T6 – Impact (Primary and Secondary Cells)
  • T7 – Overcharge (Secondary Batteries)
  • T8 – Forced Discharge (Primary and Secondary Cells)

Some tests are easier to pass than others.  The altitude test is the easiest. The vibration test, on the other hand, is intense and long-running: 3 hours in each of the three cardinal planes.  And the T1-T5 sequence typically has a negative cumulative effect.

IEC 62133
Mandated by many IEC end-device standards, IEC 62133 is the de facto standard for international compliance.  UN 38.3 transportation testing (see previous section) is an integral requirement, but does not need to be repeated.

The standard includes four tests:

  • 2.2 Molded Case Stress
  • 3.2 External Short Circuit
  • 3.3 Free Fall
  • 3.6 Overcharging of Battery

Compared to the requirements of UN 38.3, these tests are relatively easy to pass.

UL 2054
Compliance with the requirements of UL 2054 is mandated by a number of U.S. end device standards. It is a challenging standard involving roughly double the number of tests found in the UN or IEC requirements:

  • 7 electrical tests
  • 4 mechanical tests
  • 4 battery enclosure tests
  • 1 fire exposure test
  • 2 environmental tests

With the inclusion of single faults and worst-case operation, the electrical tests are the most challenging.  The abusive overcharge test is the most difficult given the overvoltage conditions applied to the faulted pack.  Abnormal charge, forced discharge, and two short circuit tests also involve significant risk of failure.

For lithium batteries, UL 2054 defers all component cell level testing to UL 1642.  Warning: Not all labs will accept another NRTL’s test results. For example, when testing a battery to UL 2054, MET Labs will accept another NRTL’s cell level UL 1642 test data and apply it to the UL 2054 testing. This saves the client time and money. We recommend avoiding NRTLs that don’t follow this client-friendly practice.

The future of UL 2054 is cloudy. UL has released the first edition of UL 62133, which is fully harmonized with IEC 62133, 2nd Edition. UL 2054 and UL 62133 essentially compete for the same test space although their requirements are quite different. The timing of UL 62133 adoption is still unfolding, but it is expected to have an impact on the future role of UL 2054 as an important U.S. compliance standard.

In addition to these three standards, MET is increasingly seeing a demand for testing to IEEE 1625 and 1725 for CTIA battery certification.  MET is a CTIA Authorized Test Lab that offers full scope CTIA-accredited battery testing and certification services for these standards.

Not sure what standard applies to your batteries?  Contact us for quick and easy answers.

Leave a Comment :, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , more...

U.S. EPA Announces Criteria for ENERGY STAR Most Efficient 2016

by on Oct.12, 2015, under ENERGY STAR

energy-star-appliancesThe U.S. Environmental Protection Agency (EPA) has announced final recognition criteria for ENERGY STAR Most Efficient 2016.

The ENERGY STAR Most Efficient designation is eligible in 12 product categories:

  • Air Source Heat Pumps and Central Air Conditioners
  • Boilers
  • Ceiling Fans
  • Clothes Washers
  • Dishwashers
  • Computer Monitors
  • Furnaces
  • Geothermal Heat Pumps
  • Refrigerator Freezers
  • Televisions
  • Ventilation Fans
  • Residential Windows

Products that meet the 2016 criteria will deliver significant savings over a conventional product as detailed here.  Final criteria for ENERGY STAR Most Efficient 2016 are summarized in this same PDF.

In addition to meeting these performance requirements, products must be certified as ENERGY STAR by an EPA-recognized certification body, like MET Laboratories.

The ENERGY STAR Most Efficient designation was created to recognize and advance the most efficient products among those that qualify for ENERGY STAR. The goal of this effort is to encourage new, more energy-efficient products into the market more quickly by targeting early adopters.

In addition to the EPA ENERGY STAR recognition and experience, MET performs a full range of energy efficiency testing for global markets, including NRCan, CEC, U.S. DoE, and EU CE marking.

Contact us for a fast and free energy efficiency testing quotation.


Leave a Comment :, , , , , , , , , , , , , , , , , , , , , , , , more...

ENERGY STAR Certification Program is Growing to Include LNE & Other Product Categories

by on Sep.30, 2015, under ENERGY STAR

LNEMET Labs was fortunate to have the opportunity recently to host U.S. Environmental Protection Agency ENERGY STAR Product Manager Verena Radulovic, who gave a talk on the ENERGY STAR Product Certification Scheme.

Here are a few key points from her presentation:

The ENERGY STAR program is a big success.  87% of households recognize the ENERGY STAR label.  And the reduction in the average power consumption of products in ENERGY STAR categories is significant (see the accompanying TV example).

About 6% of ENERGY STAR qualified products fail verification testing.  In 2014, 2,070 products were verification tested, and 122 products were disqualified.  The most common disqualifications were CFLs (33), luminaires (30), and ventilating fans (23).

The ENERGY STAR program is growing.  New product categories being introduced in 2015 and 2016 include:

  • Commercial coffee makers
  • Large network equipment (LNE)
  • Lab-grade refrigerators
  • Medical imaging
  • Electric vehicle supply equipment
  • Medium voltage distribution transformers

MET is hosting a complimentary Large Network Equipment Talk & Reception in Santa Clara, California next week.  If you or a colleague are interested in learning about new testing requirements for LNE and similar equipment, register for free here.

Leave a Comment :, , , , , , , , , , , , , , more...

Most Popular Solar UV Tests Include MIL-STD-810G Method 505.5 and ASTM Standards

by on Sep.16, 2015, under Military

Cuvmain_1c7d3a6c-c84b-4aac-a90f-bee5561e45f9all it what you want: solar radiation, UV exposure, accelerated weathering.  When is this testing necessary or advisable and which test should be used?

When is easy: You should perform solar testing if your product will be exposed to sunlight.

Which test is more difficult to answer.  There are several different types of solar tests.

One of the more popular ones is MIL-STD-810G, Method 505.5.  At 15 pages with an additional 15 pages of annexes (3 of them), the specification is detailed.  This section of the standard serves two purposes:

  1. Determine heating effects from sunshine impinging directly on equipment (Procedure I)
  2. Identify material degradation from sunshine (Procedure II)

Procedure 1 is primarily a heating effect test and is usually performed with halogen lamps following a diurnal cycle profile.  The potential impact of solar radiation heating effects include:

  • Jamming or loosening of moving parts
  • Changes in strength and elasticity
  • Loss of seal integrity
  • Changes in electrical or electronic components
  • Premature actuation of electrical contacts
  • Changes in characteristics of elastomers and polymers
  • Blistering, peeling, and de-lamination of paints, composites, and surface laminates
  • Softening of potting compounds
  • Weakening of solder joints and glued parts

Procedure 2 is a combination actinic and heating effects test using full spectrum lamps.  Material effects of solar radiation, primarily from UV exposure, include:

  • Fading of fabric and plastic color
  • Break down and fading of paints
  • Deterioration of natural and synthetic elastomers and polymers through photochemical reactions initiated by shorter wavelength radiation (especially acute for high strength polymers such as Kevlar)

As with other 810G Methods, 505.5 is a general outline and it is left to the end user to create a test plan to align the test with the anticipated environment.

Following are additional popular solar testing standards, both of which MET Laboratories is accredited for:

ASTM G154 – This test consists of exposing samples to 42 cycles of 8 hours of UVA-340 ultraviolet light at 60°C, followed by 4 hours of condensation (mimicking dew) at 50°C. Overall, this test involves 21 days of exposure.

ASTM G155 – In this test, xenon arc lamps simulate full-spectrum sunlight within a controlled test chamber.  Because xenon arc light is most similar to natural sunlight, this standard is often used for outdoor weatherization testing.

MET Labs performs fully-accredited MIL-STD-810 Method 505.5 solar testing along with ASTM G154 and ASTM G155 testing. We also work with customers to develop custom test plans to meet special requirements.

Work with the leader in environmental simulation testingcontact us today.

Leave a Comment :, , , , , , , , , , , , , , , , , , , , , , , , more...

Gulf Countries Introduce GCC Certification for Safety & EMC of Low Voltage Electrical Equipment

by on Sep.10, 2015, under EMC, Product Safety

GCC markThe Gulf Cooperation Council (GCC) Standardization Organization (GSO) has introduced a common Technical Regulation for low voltage electrical products, effective July 1, 2016.

This Technical Regulation (BD-142004-01) covers safety and electromagnetic compatibility and will affect seven GCC member states: Saudi Arabia, UAE, Kuwait, Bahrain, Qatar, Oman and Yemen.  It follows a similar existing regulation for toys.

Most covered product categories are subject to the manufacturer’s/importer’s self declaration of conformity (DoC).  As in Europe, test reports showing compliance with the national/regional standards give a ‘presumption of conformity’ with the general safety requirements. IECEE/CB Test Certificates/Reports are specifically mentioned as acceptable documentation.

The are 13 types of electrical household appliances (List 2) which are not subject to self-certification; these require approval by a Notified Body.

Products complying with the requirements must carry the special G-marking (pictured) before being placed on the market.

Some specialized equipment is not covered by this regulation, including:

  • Electrical equipment for use in an explosive atmosphere
  • Electrical equipment for radiology and medical purposes
  • Electrical parts for goods and passenger lifts
  • Electricity meters
  • Electric fence controllers
  • Radio-electrical interference
  • Some specialized electrical equipment for use on ships, aircraft or railways

Our dedicated Homologations Team and extensive network of international labs can help you get your products certified in over 65 countriesContact Us today for a free quotation or to ask a question.


1 Comment :, , , , , , , , , , , , , , , , , , , , , , , more...

Top 7 Questions about IEC 60601-1-2 4th Edition for EMC Testing of Medical Devices

by on Aug.31, 2015, under Medical


This Compliance Today post is a follow up to last week’s post on IEC 60601-1 Edition 3.1.

  1. Are there safety benefits to the 3rd edition of IEC 60601-1-2 compared to the 2nd?

The test levels required by both the 2nd and 3rd editions of IEC 60601-1-2 are the same.  The main change was in clause 4, where 3rd edition implements a risk management process.

So while the test levels are the same, the objective of the testing and what is being monitored may be different in a 2nd and 3rd edition test report.  If it can be shown that the 2nd edition testing covered all aspects of basic safety and essential performance identified in the 3rd edition risk management file, then the 2nd edition report can be used to show compliance with the 3rd edition requirements on that basis.

  1. What does the term “Essential Performance” mean?

Essential Performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.

As an example, a patient hoist has 2 performance functions: Raising the patient and lowering the patient. Through risk analysis it would demonstrate that not being able to lift the patient is an acceptable risk, but not being able to lower the patient is an unacceptable risk.  So, only lowering the patient is considered Essential Performance 

  1. For devices approved previously with 60601-1, do we have to test for Rev. 3 in the U.S. for FDA and in other places like Europe?

In the U.S., devices approved prior to the transition dates are grandfathered in and do not require further testing to the updated requirements unless they are changed in a way which requires a follow up submission to the FDA.

In Europe, devices placed on the market after the transition dates must meet the new requirements.  Currently the 3rd edition of EN 60601-1-2 applies in the EU. After December 31, 2018, EN 60601-1-2 4th edition will be required.

  1. Is the EU accepting the 4th edition now? 

The EU has not explicitly harmonized the 4th edition yet, however it should be possible to justify the use of the 4th edition to a Notified Body reviewer.

  1. What if your device is meant to generate and receive signals that violate EMC limits?

Radios contained within the device must meet the applicable radio requirements.  Intentional emitters that are not radios are covered by CISPR 11 Group 2.

  1. Are there any examples available of typical EMC test plans?

Annex G contains detailed guidance and an itemized list of what should be in an EMC test plan.

  1. Given the FDA’s Guidance on Wireless, and now this 4th edition update for RF Immunity, is it expected that this will address those FDA requirements? 

There is currently no plan to replace FDA wireless requirements with the 4th edition proximity RF testing, however this opinion may change over time as the intent and scope of the two requirements are similar.

Searching for an independent test lab for the quick and hassle-free testing and certification of your medical electrical equipment?  Look no further!  MET Labs is the U.S.’s first Nationally Recognized Testing Laboratory, and is the responsive alternative for EMC and product safety certificationContact us for a free quotation today.

Leave a Comment :, , , , , , , , , , , , , , , , , , , more...

Looking for something?

Use the form below to search the site:

Still not finding what you're looking for? Drop a comment on a post or contact us so we can take care of it!