MET 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.
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:
- Determine heating effects from sunshine impinging directly on equipment (Procedure I)
- 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.
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
This Compliance Today post is a follow up to last week’s post on IEC 60601-1 Edition 3.1.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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 certification. Contact us for a free quotation today.
In an effort to remain current with new medical technologies, product safety standard IEC 60601-1 underwent another revision with the 2012 publication of Amendment 1. More than 100 pages in length, Amendment 1 (Edition 3.1) introduces more than 20 new requirements and 60 modifications to existing requirements for medical devices.
For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles has been clarified, the amended standard includes new requirements regarding essential performance, mandates usability engineering evaluations, and requires the adoption of a formal development life cycle process for software. The amended standard also includes a number of new or revised technical specifications for electrical and mechanical hazards, as well as new product labeling and documentation requirements.
This Compliance Today blog post provides an overview of the new and modified requirements included in IEC 60601-1 Edition 3.1.
Risk Management (Subclause 4.2)
The description of risk management has been rewritten to clarify how ISO 14971:2007 should be applied. The rewrite clarifies that a full ISO 14971 assessment and post-production monitoring are not required for compliance.
Essential Performance (Subclause 4.3)
Amendment 1 now requires manufacturers to establish specific performance limits, and to evaluate essential performance characteristics under abnormal or fault conditions. In addition to these changes, essential performance is now a test criteria in assessing if a hazard is present after a specific test. Also, manufacturers must declare specific essential performance criteria in the product’s technical description.
Humidity (Subclause 5.7)
Humidity testing requirements from IEC 60601-1 Edition 2.0 have been reinstated.
Documentation (Clause 7)
A number of new documentation requirements for user manuals and instructions for use (IFU) have been added. In addition, electronic versions of all accompanying documentation must apply the usability engineering process as covered in the collateral standard, IEC 60601-1-6, Usability, in determining what information must be presented.
Marking and Labeling (Subclause 7.2.2)
Equipment and accessory labeling must include a unique serial number or lot batch identifier, date of manufacturer or “use-by” date, and manufacturer contact information.
Electrical Hazards (Clause 8)
There are a number of changes related to protections from potential electrical hazards, including defibrillation protection, protective earth and creepage and clearance distances. There are new limits for leakage current testing for functional earth connections. Protective earth testing with a power supply cord is required for devices equipped with appliance inlets. Permanently installed equipment must include a power lockout device if reconnection presents a potential hazard to a user.
Mechanical Hazards (Clause 9)
Testing for mechanical hazards related to instability and mobile equipment has been modified to include functional testing.
Temperature Testing (Clause 11)
For applied parts, temperature limits have been clarified. For overflow, equipment must be designed to ensure that basic safety and essential performance are maintained at all times.
Programmable Electrical Medical Systems (PEMS) (Clause 14)
Amendment 1 incorporates many of the specific requirements of IEC 62304:2006, Medical Device Software Life Cycle Processes, which are applicable to equipment and systems whose operation depends on software or any programmable element (also known as PEMS). In addition, Amendment 1 incorporates validation requirements for equipment connected to a network.
Construction (Clause 15)
For mechanical strength, “basic safety and essential performance” replaces “unacceptable risk.” Requirements for the construction of transformers have reverted to IEC 60601-1 Edition 2.0. Lithium batteries must comply with IEC 60086-4 (primary cells) and IEC 62133 (secondary cells).
The U.S. FDA has set a transition date of August 2016 for compliance with Edition 3.1. For the NRTL program, the U.S. Occupational Safety and Health Administration (OSHA) has adopted ANSI/AAMI ES60601-1: 2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. Both of these national standards are deemed the equivalent of IEC 60601-1 Edition 3.1, but they may also include national deviations that trigger additional requirements for regulatory approval. Thus, there is some uncertainty around transition dates.
In the European Union (EU), EN 60601-1:2006/A1:2013 (the EU’s equivalent of IEC 60601-1 Edition 3.1) has been published in the Official Journal (OJ) as a harmonized standard under the EU’s Medical Device Directive (93/42/EEC). So, as of Dec. 31, 2017, compliance with the provisions of EN 60601-1: 2006 (equivalent to IEC 60601-1 Edition 3.0) will no longer be accepted as evidence of conformity with the essential requirements of the Directive.
Adding another level of complexity, transition dates for equipment and systems subject to the requirements of a collateral and/or particular standard in the IEC 60601 series (designated IEC 60601-1-xx and IEC 60601-2-xx) may differ from those applicable to other types of devices.
For device manufacturers that use the IECEE’s CB Scheme, a further challenge is the requirements presented in the IECEE’s Operational Document OD-2055. Published in 2014, OD-2055 requires manufacturers seeking certification to IEC 60601-1 as amended to also comply with the usability engineering process that is detailed in IEC 62366-1:2015.
MET Labs is a leading agency for 3rd party testing and certification of medical electrical equipment to the latest edition of IEC 60601-1 for all major markets. Contact us for questions about Edition 3.1 or for a free quotation to test your device(s).
External Power Supplies Must Meet Level VI Energy Efficiency Requirements for U.S. DoE by February 2016
The global regulatory environment for external power supply energy efficiency has rapidly evolved over the past decade since the California Energy Commission (CEC) implemented the first mandatory standard in 2004. Now, external power supplies sold in the U.S. must meet updated and expanded U.S. Department of Energy (DoE) Level VI Energy Efficiency requirements by February 10, 2016.
The new DoE standard mandates more stringent energy efficiency levels for a greater number of external power supply types. The DoE estimates that these requirements will save consumers up to $3.8 billion and cut emissions by nearly 47 million metric tons of carbon dioxide over 30 years, equivalent to the annual electricity use of 6.5 million homes.
In the early 1990s, it was estimated that there were more than one billion external power supplies active in the U.S. alone. The efficiency of these power supplies could be as low as 50% and still draw power when the application was turned off or unconnected (a “no-load” condition). Experts calculated that without efforts to increase efficiencies and reduce no-load power consumption, external power supplies would account for around 30% of total energy consumption in less than 20 years.
While many countries still have voluntary programs harmonized to the international efficiency marking protocol system first established by the ENERGY STAR Program, the U.S., Canada, and European Union now have mandatory energy efficiency regulations in place for external power supplies.
Today, Level V will meet or exceed the requirements of any governing body around the globe. Power supply manufacturers indicate compliance by placing a Roman Numeral V on the power supply label as specified by the International Efficiency Marking Protocol for External Power Supplies Version 3.0, updated in September 2013.
The internationally approved test method for determining efficiency has been published by the IEC as AS/NZS 4665 Part 1 and Part 2. The approach taken to establish an efficiency level is to measure the input and output power at 4 defined points: 25%, 50%, 75% and 100% of rated power output. Data for all 4 points are separately reported as well as an arithmetic average active efficiency across all 4 points.
Power supply manufactures are already preparing for the coming transition in February 2016 to the more stringent Level VI standards. Along with tightened regulations for existing adapters, the new standard expands the range of products that fall under the standard to now include:
- Multiple-voltage external power supplies
- Products with power levels >250 watts
Direct Vs Indirect Operation
The new standard also defines power supplies as direct or indirect operation products. A direct operation product functions without the assistance of a battery. An indirect operation supply is not a battery charger but cannot operate the end product without the assistance of a battery. The new standard only applies to direct operation external power supplies. Indirect operation models will still be governed by the limits as defined by EISA2007.
The Level VI mandate also includes these exemptions:
- A device that requires Federal Food and Drug Administration AS/NZS 4665 listing and approval as a medical device in accordance with section 360c of title 21
- A direct operation, AC-DC supply with output voltage less than 3 volts and output current ≥1,000 milliamps that charges the battery of a product that is fully or primarily motor-operated.
The DoE Level VI requirement date is February 10, 2016, but it is important to note that compliance with the new standard will be regulated from the date of manufacture, so legacy products can still be shipped as long as the manufacture date is prior to the transition date. Labeling requirements will be required to meet the same International Efficiency Marking Protocol for External Power Supplies Version 3.0 as the current Level V standard.
Globally, it is expected that other nations will soon follow suit with this standard. In the EU, the mandatory European Ecodesign Directive for external power supplies is currently undergoing revision discussions and it is expected to harmonize with most, if not all, of the U.S. standards. Countries with existing efficiency regulations in line with the U.S., including Canada and Australia, are expected to harmonize with the new standard as well.
In addition to testing for the Department of Energy, MET is your one-stop-shop for energy efficiency testing and certification for ENERGY STAR, EU Ecodesign Directive, Natural Resources Canada, and the California Energy Commission.
Major changes to the Electrical Appliances Safety Control Act include:
- The validity period of self-regulatory safety confirmation registration has been changed from 5 years to as much as 10 years, depending on the risk level assessed.
- Products with rated voltage not exceeding 30V AC and 42V DC are now excluded from KC marking unless hazardous effects remain.
- The scope of rated voltage of each product regulated has been modified to exclude industrial and specific purpose products.
- For cables and cords, switches, and circuit breakers, products for use with AC voltage are only subject to KC mark.
- Clarification of product names subject to KC mark. For example, electrical stove is now classified into “pellet stove” and “electrical stove.”
- Revision of particular scopes for batteries, with the intention of improving battery safety.
MET Labs maintains an office in Seoul, Korea that stays abreast of changes to Korea KC mark regulations. Contact MET Korea directly at 82-31-697-8202 or firstname.lastname@example.org . For U.S.-based manufacturers, contact MET here.
Due to Europe’s New Legislative Framework, the ATEX Directive 94/9/EC will be replaced by ATEX Directive 2014/34/EU in 2016, for the testing and certification of certain equipment intended for potentially explosive atmospheres in the EU.
From the manufacturer perspective, the changes are not significant, as there are no changes to the Essential Health and Safety Requirements in Annex II of the new directive. Therefore the directive does not affect the standards that are used, and there are no significant changes in the remainder of the Annexes regarding the conformity assessment procedures for manufacturers.
Here are the most important changes for manufacturers:
- The EC declaration of conformity must be replaced by an EU declaration of conformity.
- The EC type examination certificate must be replaced by an EU type examination certificate.
- Importers are required to put their names and addresses on the products.
- Manufacturer’s, importer’s and distributor’s responsibilities for traceability and market surveillance are more precisely defined.
Here is what stays the same:
- CE and ATEX marking requirements.
- The scope of the directive and its essential health and safety requirements.
- The conformity assessment procedures.
- The classification of groups and categories of equipment.
Here is the transition date: On April 19, 2016 Directive 94/9/EC will be abrogated. It remains applicable until this date. From April 20, 2016 the new 2014/34/EU directive will come into force.
Certificates issued according to 94/9/EC remain valid until changes are made affecting the product. In the case of modification, a new certificate with a new number, under Directive 2014/34/EU, must be issued.
When it comes to aircraft safety, the stakes are high. There are tons of components on a commercial airliner. One malfunction for any reason can be catastrophic. That’s why equipment testing is crucial to ensure hardware meets quality and safety standards.
Here’s a summary of some of the most frequently performed aircraft equipment tests.
DO-160 is a standard maintained by the Radio Technical Commission for Aeronautics (RTCA) for testing avionics hardware. It applies to equipment in helicopters, general aviation aircraft and commercial airplanes. DO-160 testing covers most everything that might cause an avionics component to falter or fail. The most current version is DO-160G, which was approved in December 2010.
DO-160 applies to the United States, and there’s an identical set of standards for Europe, known as EUROCAE ED-14. (EUROCAE is the non-profit European Organisation for Civil Aviation Equipment.)
Electromagnetic Compatibility (EMC)
There are thousands of components in today’s jetliners. Each of these components must be resilient to electrostatic discharge, irregular voltage, magnetic fields and other unpredictable changes.
The RTCA/DO-160 standard covers these EMC test procedures:
Section 15 – Magnetic Effect
Section 16 – Power Input
Section 17 – Voltage Spike
Section 18 – Audio Frequency Conducted Susceptibility – Power Inputs
Section 19 – Induced Signal Susceptibility
Section 20 – Radio Frequency Susceptibility (Radiated and Conducted)
Section 22 – Lightning Induced Transient Susceptibility
Section 23 – Lightning Direct Effects
Section 25 – Electrostatic Discharge (ESD)
To do these tests, MET Labs utilizes three state-of-the-art RF anechoic EMC chambers with 1/3-phase 400Hz RF power filters with Power Factor Correction Coils (PFCCs) and RF filtered DC power.
Lightning strikes are a routine part of every commercial airplane’s experience. The Federal Aviation Administration (FAA) estimates that every airliner in the U.S. is hit by lightning once per year on average. A single bolt of lightning may send a current of 200,000 amps through the airplane, and avionics electronics must be able to withstand the effects of this strike. That’s why RTCA/DO-160 has a lightning requirement, and now the latest version of MIL-STD-461 (Revision G) has it too.
Deepening the impact of lightning strikes is the increasing use of lighter composite materials in airframe construction, including that used in the Boeing 787 Dreamliner and Airbus A380. Many composites don’t conduct lightning currents the way metal airframes do, leading to the possibility of higher voltages and currents affecting aircraft equipment.
MET performs Section 22 lightning testing up to level V, and has the unique capability to perform this testing at 3rd party sites, utilizing a portable Lightning Test System.
High intensity radiated fields (HIRF) testing is a form of EMC/EMI testing applicable to equipment that is subject to extreme electromagnetic environments.
Utilizing a 20,000 V/m Reverberation Chamber, MET performs HIRF testing to satisfy RTCA requirements, as well as FAA HIRF Rule & Advisory Circular 20-158.
Airplanes operate in all sorts of environmental conditions: searing heat, driving rain and dust, shearing winds, and with a regular risk of icing. They also have to withstand UV and solar radiation.
RTCA/DO-160 covers these environmental simulation test procedures:
Section 4 – Temperature and Altitude
Section 5 – Temperature Variation
Section 6 – Humidity
Section 7 – Operational Shocks and Crash Safety
Section 8 – Vibration
Section 9 – Explosion Proofness
Section 10 – Water Proofness
Section 11 – Fluids Susceptibility
Section 12 – Sand and Dust
Section 13 – Fungus Resistance
Section 14 – Salt Spray
Section 24 – Icing
From high school physics, we remember that acceleration is how fast your velocity is changing. G-forces stress an airframe and many of its components, especially during take-off and landing.
There’s a variety of acceleration tests that are conducted on airframes and their components, including the use of machinery that spins components in a centrifuge. MET’s new Centrifugal Static Acceleration Tester delivers 150 g’s for test equipment up to 35 pounds, or 40 g’s up to 200 pounds.
Modern aircraft operate at altitudes between 30,000 and 40,000 feet, and the air pressure at these altitudes is very low relative to the air pressure at sea level.
Airframes are pressurized to provide oxygen to the crew and passengers, but there is the potential for an “explosive decompression,” should the airframe fail. Aircraft components need to withstand this rapid transition to outside air pressure.
MET can test avionics equipment from sea level to 100,000 feet, with various simulated atmospheric conditions, including pressure, temperature and humidity.
Airplane equipment has to undergo rigorous vibration stress testing to make certain it won’t fall apart in flight. One of the main sources of vibration in an airframe is turbulence, and that places random vibrations forces on the aircraft. But airplane components must meet standards for both random and sine-wave vibration.
With a new Unholtz-Dickie K-Series Shaker, MET’s shock & vibe capacity is:
- 17,000 lbf Sine
- 16,000 lbf Random
- 34,000 lbf Shock
- 3 Inch pk-pk Stroke
At MET, we have the experience and equipment to perform DO-160 testing, as well as special test programs for commercial aircraft manufacturers like Boeing and Airbus, plus for satellite manufacturers. Contact us for a free quote today.
In June, MET Labs Product Safety Lab Director Rick Cooper gave a presentation in Oslo, Norway on Household Product Certification in the United States.
For those who missed it, here is a basic summary:
In the United States, UL 60335-1 covers the General Requirements for electrical/electronic household products. This harmonized standard is part of the U.S. NRTL program. The U.S. participates in the HOUS category of the international IECEE CB Scheme for IEC 60335-1.
The fifth edition of UL 60335-1 is part of a tri-national standard, along with CAN/CSA-C22.2 No. 60335-1-11, 1st edition (Canada) and NMX-J-521/1-ANCE, 1st edition (Mexico). The tri-national standard was published October 31, 2011 and is based on IEC 60335-1, Edition 4.2:2006.
In regards to Part 2 particular standards, the U.S. only recognizes IEC 60335-2-3, 5th edition (Electric Irons) for the CB Scheme. There is a U.S. version of this standard: UL 60335-2-3. There are a number of other published -2s, but they need to be harmonized before they are suitable for the CB Scheme. These include UL 30335-2-8 (Shavers & Hair Clippers), UL 30335-2-34 (Motor-Compressors), and UL 30335-2-40 (Heat Pumps, A/Cs, and Dehumidifiers).
The lack of harmonized Part 2 standards is primarily due to:
- Different materials, insulation requirements, and voltages between the U.S. and other countries
- Off-the-shelf universal power supplies that are suitable for this product category are unavailable
Unlike the OFF industry, where off-the-shelf universal supplies are abundant, two versions of HOUS products need to be built, so there is not a lot of interest in developing Part 2s by the relevant industries.
Putting the international CB Scheme aside, OSHA today recognizes 38 household product standards for the NRTL Program, including many legacy standards. See the full list of all category standards recognized by OSHA here.
Over 25 years ago, MET Labs became the first NRTL, and today is accredited by OSHA for over 180 UL standards. MET is also a recognized member of the IECEE CB Scheme, for product safety approval in over 50 countries.
Contact us today for a free quote to test your household products, or any other electrical/electronic equipment.