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

by on Aug.31, 2015, under Medical

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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.

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IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

by on Aug.24, 2015, under Medical, Product Safety

EN-60601-monitorIn 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).

Transition Dates
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).

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External Power Supplies Must Meet Level VI Energy Efficiency Requirements for U.S. DoE by February 2016

by on Aug.11, 2015, under ENERGY STAR

Tdt100-che 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.

History
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.

Global Requirements
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.

Performance Specs
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.

Level VI
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.

Exemptions
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

OR

  • 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.

Legacy Products
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.

Looking Forward
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.

MET Labs is geared up to provide independent test reports to verify your compliance with the new Level VI standard for external power supplies.  Contact us for a free quote today.

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.

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Korea Changes Electrical Appliances Safety Control Regulation for KC Mark

by on Aug.03, 2015, under Product Safety

Tkc markhe Korean Electrical Appliances Safety Control Regulation for KC marking has recently been amended; the new regulation took effect August 1, 2015.

Major changes to the Electrical Appliances Safety Control Act include:

  1. 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.
  2. Products with rated voltage not exceeding 30V AC and 42V DC are now excluded from KC marking unless hazardous effects remain.
  3. The scope of rated voltage of each product regulated has been modified to exclude industrial and specific purpose products.
  4. For cables and cords, switches, and circuit breakers, products for use with AC voltage are only subject to KC mark.
  5. Clarification of product names subject to KC mark.  For example, electrical stove is now classified into “pellet stove” and “electrical stove.”
  6. 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 metkorea@metlabs.com .  For U.S.-based manufacturers, contact MET here.

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ATEX Directive 2014/34/EU Replaces 94/9/EC for Explosive Atmosphere Equipment in EU

by on Jul.27, 2015, under Product Safety, Uncategorized

interior scene of large refineryDue 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.

MET Labs is the rare agency that offers hazardous location approvals for ATEX (Europe), NRTL & SCC (U.S. & Canada), IECEx (International) and specialty programs for MSHA and the U.S. Coast Guard.

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Avionics RTCA DO-160 Testing Includes EMC and Environmental Components

by on Jul.21, 2015, under EMC, RTCA

aircraftWhen 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.

RTCA/DO-160
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
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.

HIRF

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.

Environmental Simulation
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

Acceleration
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.

Altitude
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.

Vibration
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.

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UL 60335-1 is Part of Tri-National Standard for Product Safety of Household Products

by on Jul.02, 2015, under Product Safety

appliance product safetyIn 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.

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EV & EVSE Safety Testing and Certification Becoming More Frequent

by on Jun.22, 2015, under Battery, Product Safety

teslaWith the growth of electric vehicles and their associated technology ecosystem, MET Labs is seeing higher levels of testing and certification in this industry.  Following is a summary of the standards that apply to electric vehicles (EVs) and electric vehicle supply equipment (EVSE).

EV UL Safety Standards:

UL 2202 EV Charging System Equipment
UL 2251 Standard for Plugs, Receptacles, and Couplers for Electric Vehicles
UL 2231-1 and UL 2231-2 Personnel Protection Systems for EV Supply Circuits
UL Subject 2580 Batteries for Use In Electric Vehicles
UL Subject 2594 EV Supply Equipment

EV International (IEC) Standards: 

IEC 61851 Electric Vehicle Conductive Charging System
IEC 61982 Secondary Batteries for the Propulsion of Electric Road Vehicles – Performance and Endurance Tests
IEC 62133
Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes – Safety Requirements
IEC 62196 Plugs, Socket-Outlets, Vehicle Connectors and Inlets – Conductive Charging of EVs

EV SAE Standards: 

SAE J1772 Electric Vehicle and Plug in Hybrid Electric Vehicle Conductive Charge Coupler
SAE J2293
Energy Transfer System for Electric Vehicles
SAE J2464 Electric and Hybrid Electric Vehicle Rechargeable Energy Storage System (RESS) Safety and Abuse Testing
SAE J2894 Power Quality Requirements for Plug-In Electric Vehicle Chargers
SAE J2929 Electric and Hybrid Vehicle Propulsion Battery System Safety Standard – Lithium-based Rechargeable Cells

The Authority Having Jurisdiction (AHJ) – often electrical code inspectors – have final say in the acceptance of equipment and electrical installations in the United States.  The U.S. National Electric Code (NEC) informs the AHJ that a piece of equipment is acceptable if it has the listing mark of an approved Nationally Recognized Testing Laboratory (NRTL).  In the case of EV charging systems, Article 625 indicates that all electrical materials, devices, fittings and associated equipment shall be listed or labeled.

Over 25 years ago, MET Labs became the first NRTL, and today is capable of performing testing to all major EV and EVSE standards.

Contact us today for a free quote to test your EV equipment, or your non-EV products in hundreds of other categories.

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R&TTE to RED Transition Period Changes for Radio Equipment CE Marking

by on Jun.15, 2015, under EMC, Wireless

RED
Notified Bodies for the R&TTE Directive (R&TTE Compliance Association – to be renamed RED Compliance Association) met on June 1-2, 2015 in Goteborg, Sweden to discuss issues related to the R&TTE to RED transition for European radio equipment regulations.

Following are highlights of the discussions held there.

Transition Change
The Commission announced an important new interpretation about the transition period from the R&TTED to the RED. During the transition period to the new RED (June 13, 2016 to June 13, 2017), manufacturers can introduce new products using either the R&TTE Directive or the new RED Directive.

Therefore, the Commission will need to maintain the existing list of harmonized standards for the R&TTE Directive until June 2017.

Directive Scope Changes
The scope of the RED requires that broadcast receivers and transmitters under 9 Khz move from the EMC Directive to the RED. As such, these products fall under the one year RED transition period. For the two month period of April 20, 2016 (EMC Directive effective date) to June 13, 2016, these products would technically have to be in compliance with the new EMCD and LVD – but the Commission has been asked to identify a practical approach to this issue so that manufacturers of these products do not need to update the DoC twice in a short period.

ETSI Standards Development
Michael Sharpe presented a summary of ETSI’s updated standards development program in response to the changes to the Radio Equipment Directive.  See the November meeting information, below, for more information about ETSI standards development.

Technical Guidance Note Transfers
The Chairman will review all existing TGNs to propose which R&TTE CA TGNs should be transferred to become RED CA TGNs. A list of the proposed changes will be presented at the November meeting. Removed TGNs will remain in the archived area of the RED CA website. Note that access to TGNs is being restricted. Non-members will now need to send an e-mail request to the Secretary to obtain these documents.

Next Meeting
The proposed dates for the next meetings of the EUANB and RED (RTTE) CA are November 2-3, 2015 in Nice, France. In addition, on November 4, 2015, there will be an ETSI workshop for attendees to discuss standards changes. Proposed topics (specific ETSI standards of interest) should be e-mailed to Chairman Nick Hooper by July 1, 2015 for consideration: chairman@rtteca.com.

Special thanks to NIST for providing much of the information in this post.

As a Conformity Assessment Body (CAB) in accordance with the US-EU mutual recognition agreement, MET Labs acts as a Notified Body (NB) to generate tests suites and issue NB opinions for radio equipment sold in Europe. Contact us today for a free quote to support your Declaration of Conformity (DoC) for CE marking.

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Audio and Video Equipment Must Adhere to EN 60065:2014 for Conformity with Low Voltage Directive

by on Jun.08, 2015, under Product Safety

Equipment2Starting November 17, 2017, all audio, video, and similar electronic apparatus bound for Europe must meet the safety requirements of the 8th edition of EN 60065, published in 2014.

EN 60065:2002+A1:2006 +A11:2008+A2:2010 +A12:2011 will cease to be valid as of the November 17, 2017 date of withdrawal (DOW). All existing certificates must be updated to EN 60065:2014 before that time.

The new EN 60065:2014 standard is harmonized according to the R&TTE Directive (1999/5/EC), Low Voltage Directive (2006/95/EC) and General Product Safety Directive (2001/95/EC). Audio/video products within the scope of the RTTED or LVD directives must be in compliance with the standard in order to carry the CE mark.

Products found to be out of compliance might face a sales ban or financial penalties levied by European authorities.

EN 60065:2014 applies to electronic apparatus designed to be powered from mains, supply apparatus, batteries, or remote power feeds and intended for the reception, generation, recording, or reproduction of audio, video and associated signals. This standard primarily concerns apparatus intended for household and similar general use, although professional apparatus is also covered, unless falling specifically within the scope of other standards.

The principal changes in this 8th edition as compared with the 7th edition are:

  • New requirements for coin/button cell batteries and portable secondary sealed cells and batteries (other than button)
  • Addition of requirements for LEDs
  • Requirements for creepage distances are aligned with IEC 60950-1
  • Change in optocoupler requirements
  • New requirements for wall and ceiling mounting means
  • New requirements for non-floor standing televisions likely to be used in the home and weighing over 7 kg

MET Labs is offering product safety testing according to the new standard, or for other A/V standards for all major markets.  MET is trusted by leading A/V manufacturers, including Peavey, Marshall Amplification, and Suzuki.

Contact us today for a free quotation.

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