OSHA Close to Authorizing NRTL Certification to ANSI/AAMI ES60601-1 for Medical Equipment

by admin on Aug.19, 2014, under Medical, Product Safety

After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program.

In March 2014, OSHA announced through a Federal Register Final Notice its incorporation of  ANSI/AAMI ES60601-1 into the list of Appropriate NRTL Program Test Standards.  This version of the standard is the U.S. National Version of IEC 60601-1 + A1.

OSHA delayed NRTL recognition for the U.S. version of IEC 60601-1:2005 (3rd edition) due to what it saw as subjective compliance requirements, as well as statements in the standard that would have required the NRTL to accept statements from the manufacturer without the ability for the NRTL to verify the validity of these statements.

The changes in language introduced in Amendment 1 (496 changes for the IEC standard) allows the NRTL to verify the validity of data accepted from the manufacturer.

Here are some of the key changes in AAMI ES60601-1 as compared to UL 60601-1:

  • Clause 9.6 Acoustic Energy – Not included in UL 60601-1
  • Clause 9.7.2-.4 Pressure vessels and parts subject to pneumatic and hydraulic pressure – Not included in UL 60601-1
  • Clause 9.7.6 Pressure control device – Not included in UL 60601-1
  • Clause 9.8 Mechanical hazards associated with support systems – This is a unique mechanical test not included in UL 60601-1
  • Clause 11.2.1 Oxygen Rich Environment – An optional additional test if evaluation is not sufficient for proving that the product is not an ignition hazard in an oxygen-rich environment
  • Clause 15.3.5 Rough handling test – Additional ascending shock testing and door frame shock testing is included that was not present in UL 60601-1
  • Clause 15.4.3.4 Lithium batteries – Not included in UL 60601-1

MET Labs is OSHA-recognized for UL 60601-1, and is expecting to soon be recognized for ANSI/AAMI ES60601-1:2005/(R)2012 as well.  Contact us for a free fast-response quote for electro-medical equipment testing and certification for any major market.

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

FCC Part 15 DFS Testing Requirements Change for U-NII Devices

by admin on Aug.11, 2014, under EMC, Wireless

To accommodate changes in the Federal Communication Commission’s (FCC) Docket 13-49, the Dynamic Frequency Selection (DFS) test procedure document KDB 905462 D02 UNII DFS Compliance Procedures New Rules has been issued. 

The document describes the compliance measurement procedures for performing DFS tests under FCC Part 15 Subpart E Rules required for U-NII (Unlicensed –National Information Infrastructure) equipment that operates in the frequency bands 5250-5350 MHz and/or 5470-5725 MHz.

A U-NII network will employ a DFS function to detect signals from radar systems and to avoid co-channel operation with these systems. 

Section 6 provides the parameters for required test waveforms, minimum percentage of successful detections, and the minimum number of trials that must be used for determining DFS conformance.

One of the new requirements is for devices to detect a new radar waveform for DFS testing.  Historically, the FCC has required devices to detect 5 radar types. The new rules require detection of a 6th radar type which they designated as Type 1. A previous waveform which was designated as Type 1 is now called Type 0.  See the accompanying Table 5.

These rules became effective on June 2, 2014.  FCC has established a transition period:

  • New devices will be permitted to be approved until June 1, 2015 under the old rules
  • Starting June 2, 2016, all devices approved partially or completely under the old rules cannot be marketed, and permissive changes will not be permitted for devices approved under the old rules, unless they meet the requirements of the new rules

MET Labs has the capability to generate the new radar type using Agilent hardware coupled with custom software. Get tested to the latest DFS requirements on new products or update an existing product with a Class II Permissive Change.  Get a free quote now.

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

ENERGY STAR Certification of Set-Top Boxes Now to Version 4.1

by admin on Aug.04, 2014, under ENERGY STAR

As of August 1, 2014, EPA ENERGY STAR Certification Bodies – including MET Labs – are only certifying set-top boxes (STBs) and cable boxes to the new Version 4.1 specification.

No new certifications to Version 3.0 are allowable, although existing Version 3.0 certifications will remain valid for the purposes of ENERGY STAR qualification until December 19, 2014.  At that time, any product shipped with an ENERGY STAR label must meet Version 4.1 requirements.

The 4.1 specification covers the full suite of cable, satellite, internet protocol (IP), terrestrial, and over-the-top STBs and keeps pace with a quickly evolving market by adding requirements for displayless gateways as well as enhanced functionality like high efficiency video processing (HEVP) and ultra high definition (UltraHD) content transmission, both of which support transmission of richer content.

The 4.1 specification also adopts the EPA’s approach to incentivizing energy saving multi-room configurations and deep sleep and establishes a test method for ENERGY STAR that harmonizes with the Voluntary Agreement for Ongoing Improvement to the Energy Efficiency of Set-top Boxes (VA).

Note: The new spec says STBs must be tested under worst case in terms of configurations and service provider networks. ENERGY STAR Partners may certify STBs that cannot meet the ENERGY STAR requirements in some configurations or on some networks if they assign a unique model identifier to the STBs that do meet them.

MET Labs is an EPA-recognized lab and certification body for 15 ENERGY STAR product categories.  Get a free quote now to evaluate your product to the STB 4.1 specification or any other energy efficiency standard, including the Version 6.0 ENERGY STAR specification for computers.

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

FCC Issues Guidance on New E-Labeling

by admin on Jul.29, 2014, under EMC, Wireless

On July 11, 2014, the FCC’s Office of Engineering & Technology (OET) released new guidance giving some consumer electronics manufacturers more flexibility in digitally labeling (e-labeling) their products.   

The guidance advises that all devices with an integral (non-removable) screen can now display that label digitally on that screen, and up to three steps deep into the device menu.  The user manual must include information on accessing that FCC info, or it can be on the equipment’s Web site.  

Removable labels with the FCC info must still be on the product or its packaging when it is shipped and sold.  

Formerly, the FCC required equipment that requires FCC certification to have a fixed nameplate or etched label (see the iPhone hieroglyph) listing its FCC ID and any other requirements of operation.

The benefits of e-labeling include:

  • Cost savings, especially as devices become smaller
  • The potential to provide more information, like recycling or trade-in opportunities
  • The ability to update information remotely to address any inaccuracies

The FCC had already permitted e-labeling for a small subset of devices.  In 2001, the Commission’s rules authorizing software defined radios (SDR) permitted the voluntary use of e-labeling by device manufacturers.     

MET Labs is a leading provider of FCC testing and FCC certification for electronic device electromagnetic compatibility. 

Meet with MET at Super Mobility Week, North America’s largest forum for mobile innovation, powered by CTIA.

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

Some Electronic Devices Are Exempt from FCC EMC Testing

by admin on Jul.22, 2014, under EMC, Wireless

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:

  1. A digital device utilized exclusively in any transportation vehicle including motor vehicles and aircraft.  Note: wireless devices are subject to other FCC rules.
  2. A digital device used exclusively as an electronic control or power system utilized by a public utility or in an industrial plant.
  3. A digital device used exclusively as industrial, commercial, or medical test equipment.
  4. A digital device utilized exclusively in an appliance, e.g., microwave oven, dishwasher, clothes dryer, air conditioner, etc.
  5. 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.
  6. Digital devices that have a power consumption not exceeding 6 nW.
  7. 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).
  8. 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.

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

MIL-STD-810G Change Notice 1 Incorporates Many Climatic & Dynamic Updates

by admin on Jul.16, 2014, under Military

The U.S. Department of Defense (DoD) recently issued Change Notice 1 to MIL-STD-810G, Environmental Engineering Considerations and Laboratory Tests.  This change notice incorporates more changes – climatic and dynamic – than any previous revision of -810.

A PDF of Notice 1 is available here.  It’s a bulging 1,058 pages, over 280 pages more than the Revision G alone and more than twice as many pages as Revision F.  Changes are marked by lines in the margins.   

Major changes include:

  • In Part 1, a significantly expanded section on the Life Cycle Environmental Profile (LCEP)
  • In Part 2, all test methods – 500 through 528 – have been updated with a new note
  • Only Method 528 can be called out in blanket fashion now
  • A rewrite of mechanical shock
  • Additional guidance in combining procedures

MIL-STD-810 is used by both the U.S. military and industry to assure that the environmental design and test limits of equipment match the requirements that equipment will face in actual use.

Whether a military product must be tested to Change Notice 1 is dependent on the DoD contract.  The DoD uses the product’s life cycle environmental profile and its anticipated deployment region to determine which standard version to specify.

MET Labs is an elite 3rd Party Test Lab for Military and Commercial Aircraft equipment testing, and has top-flight experience working with every top defense contractor and commercial aircraft manufacturer and many of their suppliers.  Contact us for a rapid-response quote for EMC or Environmental Simulation testing.

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

European Commission Considering eCompliance System

by admin on Jun.16, 2014, under Europe, Regulation

The European Commission is contemplating developing an “eCompliance System” and has published a “Preliminary Reflections on eCompliance” paper on how it would work.  Following is a summary of this report that was distributed at the May 2014 meeting of the Group of Notified Bodies under the EMC Directive (EUANB) in Amsterdam.

As products become more complex while product cycles become shorter, the Commission believes it is necessary to explore how compliance with Union harmonisation legislation can be demonstrated/controlled electronically (“eCompliance” concept) instead of the traditional paper-based approach.

Objective
The primary objective is to maintain protection of the public interest, while reducing the administrative burden for manufacturers (especially SMEs), Notified Bodies, and authorities.

Process
In an eCompliance context, the process of demonstrating compliance would become more interactive: manufacturers and other operators, Notified Bodies (if involved in the conformity assessment procedure) and authorities would share information and provide real-time feedback to each other.

This may lead to a situation where the border between conformity assessment (ex-ante control) and market surveillance (ex-post control) would not be so clearly defined – authorities may have the opportunity to monitor a product before it is placed on the market.

Communication
Various tools (e.g. e-labelling, digital market surveillance, electronic declarations of conformity, etc.) could function in all official Union languages and improve communication:

  • Between authorities and manufacturers
  • Between authorities and Accreditation/Notified Bodies and between Accreditation/Notified Bodies themselves
  • Between authorities

Commercial secrets and confidentiality aspects would be protected by a system of access authorizations.

In order to avoid the proliferation of IT tools, the Commission would examine whether the eCompliance System should be part of the Information and Communication System on Market Surveillance (ICSMS).

Planning for an eCompliance System in Europe is still very preliminary, with many questions to be answered and stakeholders to be consulted.  Subscribe to Compliance Today to be kept apprised on further developments in this area.

Selling electrical/electronic products in Europe?  MET Labs is a leading provider of testing services to support CE marking.  Contact us today for a free fast-response quotation.

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

Radio Equipment Directive (RED) Replacing R&TTE Directive, is Published in OJ

by admin on Jun.05, 2014, under EMC, Wireless

The Radio Equipment Directive (RED) – 2014/53/EU – has been published in the Official Journal.  This Directive is replacing the RTTE Directive (1999/5/EC).

You can read more about the changes in the new RED in a previous Compliance Today post.

Timetable
May 22, 2014 – Publication in OJ
June 12, 2014 – Entry in force of RED
June 12, 2016 – Member states transposition period end date
June 12, 2016 – RTTE Directive 1999/5/EC repeal date
June 13, 2016 – Member states must apply the new RE Directive by this date
June 13, 2017 – Products compliant with the old Directive market placement end date

MET Labs
is a leading provider of EMC and Wireless Testing services.  Contact us today to test your radio equipment devices for Europe or any other major global market.

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

IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes

by admin on May.28, 2014, under EMC, Medical

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. 

Dates
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. 

Changes
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

MET Labs has extensive experience doing EMC testing and product safety testing for medical equipment and scores of other product categories.

Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.

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

No Standard? No Problem. Custom Test Plans Measure Reliability, Accuracy & Efficiency

by admin on May.20, 2014, under EMC

Most electrical product testing is to a published standard, but not always.  MET Labs has a rich history of developing custom test plans that meet manufacturers’ specific needs. 

One reason for developing a custom test plan is to check equipment performance against marketing claims made by the equipment manufacturer, or to check the performance of your product against a competitor’s product.  Performance can include reliability, accuracy, safety, energy efficiency, or other factors.

A recent customer example comes from a large industrial solutions company that asked MET to test the performance of its noise isolation transformer against its own marketing claims.  The transformers are sold to schools, hospitals and small offices (especially in high lightning strike areas) to protect against transient overvoltage, spikes/surges and other undesirable noise.

The company asked us to measure the capacitance and the common and normal mode noise attenuation between the primary and secondary of their transformers.  We found that there was no established test procedure standard to refer to, so we developed one and had it approved by the customer.

Here is the basic setup we developed to measure the transformer’s capacitance: The transformer and test equipment was wired according to the accompanying diagram.  At each test frequency, the signal generator was set to output Vrms (Vin), and the spectrum analyzer was set to measure Vrms (Vout).  The following formula was used to calculate the capacitance:

C = [Kf((Vin/Vout)-1]^-1, where K=2π*50Ω and f=frequency in Hz. 

The accuracy of this test method and our test equipment was checked by measuring a range of known capacitors prior to measuring the transformers under test.

Similarly, we developed test methods to measure common and normal mode noise attenuation.

What were the results?  Customer test results are confidential so we can’t say, but the customer is satisfied and we are looking forward to the next non-‘standard’ testing challenge they have for us.

Have a challenging application?  Tell us about it – we can help.

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