TÜV Rheinland Blog

RoHS2 Updates: Changes coming to RoHS2 (2011/65/EU)

Posted by Jen Picardo on Mon, Jun 15, 2015 @ 10:00 AM
The day is coming when the infamous 6 restricted substances will be increased.  Annex II will have 4 phthalates added in the near future per the draft proposal.  Pack 8 exemption evaluations also began on March 13, 2015.


The draft proposal for the addition of 4 phthalates has been published by the European Commission:

  • DEHP
  • BBP
  • DBP
  • DIBP

The restriction limit for the above mentioned phthalates will be 0.1% for each of the substances.

The evidence regarding the use of the 4 phthalates has found that when used with EEE, a negative impact is the result for recycling processes as well as human health and the environment.

As there are currently substitutes for the 4 phthalates which have less of a negative impact, a restriction will be implemented via the 2011/65/EU Directive.

The provisions of the restriction will come into effect on July 22, 2019 for categories 1-7, 10 and 11. For categories 8 & 9, there will be an extended effective date of July 22, 2021 for the following: 

  • medical devices
  • in-vitro medical devices
  • monitoring and control instruments
  • industrial monitoring and control instruments

Pack 8 RoHS evaluations started on March 13, 2015 and will run a period of 9 months.  Pack 8 will cover 3 new exemption requests:

  • Lead in thin film electronic sensor elements such as pyroelectric sensors or piezoelectric sensors
  • Lead in high voltage cables and cable assemblies for a rated voltage higher than 250kV DC, containing up to 4% lead by weight” (for industrial monitoring and control instruments, Annex IV)
  • Lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as phototherapy lamps containing phosphors such as BSP (BaSi2O5:Pb) (Annex IV)

The phthalates to be included may be present in your product.  Getting a head start to assess the current content is critical as this new restriction could require a product re-design or re-formulation.   TÜV Rheinland is a service provider that can assist with determining the phthalate content in youproduct and give you a head start on this upcoming restriction. Call 888-743-4652 or email us!


Topics: RoHS/REACH

TÜV Rheinland is in the forefront of wireless technology with regulatory testing and industry driven marks (such as Wi-Fi®, Bluetooth, ZigBee®, and others)

Posted by Hope Mascott on Thu, Jun 04, 2015 @ 04:28 PM

Offers Wide Range of Testing Programs as a Result of Relationships with Major Wireless Industry Alliances


When it comes to testing and certifying wireless products for global markets, it pays to find a provider with expertise across all networks, technologies and standards, both existing and still in development. Along with our government mandated testing (FCC, CE, and others), we can provide the interoperability to wireless technologies in our Pleasanton California location.

With so many safety, acceptance, interoperability, and market development pieces in the compliance puzzle, TÜV Rheinland can help you figure out the best way to get the product to market. The company’s experts sit on committees of standard development organizations and are members of multiple industry groups to keep abreast of the latest in the wireless regulation area. TÜV Rheinland is an active member of the industry alliances listed below and tests a multitude of products for conformance to their certification programs.

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Wi-Fi Alliance®

Today, billions of Wi-Fi® products carry a substantial portion of the world’s data traffic in an increased variety of applications. As one of only two Wi-Fi Alliance® authorized testing laboratories in the US and one of 19 worldwide, TÜV Rheinland North America helps bring Wi-Fi to homes and businesses. Along with other members, TÜV Rheinland is an active participant in the Alliance’s interoperability and spectrum, and regulatory programs and market development efforts.

Recognized worldwide, the Wi-Fi certification program aims to ensure the best user experience. TÜV Rheinland tests any and all Wi-Fi enabled devices to make them eligible for a Wi-Fi CERTIFIED™ seal of approval, which tells the consumer that the product has passed tests for interoperability and industry-standard security protections. 


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ZigBee® Alliance

The Internet of Things is making headway across all areas of our life: Smart Home devices monitor energy use, control heating and cooling and ensure security. Utilities use smart metering and smart grid solutions to manage the delivery and use of water and energy. Retailers keep customers coming back with faster checkouts, in-store support, and in-store item location. Many of these interoperable devices speak the wireless language of ZigBee®, the only open, global wireless standard that provides the foundation for the Internet of Things by enabling everyday devices to connect to one another.

TÜV Rheinland is a member of the ZigBee Alliance and contributes to development of innovative, reliable and easy-to-use ZigBee standards. Experienced engineers and technicians test a wide variety of ZigBee products for use in consumer, commercial and industrial applications.


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Wi-SUN Alliance™

Wi-SUN Alliance™ strives to advance seamless connectivity by promoting the IEEE 802.15.4g™ standard-based interoperability for international regional markets. TÜV Rheinland is an independent authorized test laboratory for Wi-SUN Alliance and evaluates a wide range of consumer, business, and operator-specific products to ensure that they deliver the best user experience and meet the industry standards. Specifically, TÜV Rheinland tests networking infrastructure, smart meter communications devices, consumer electronics and modules to the relevant protocol standards and for interoperability with other Wi-SUN CERTIFIED equipment operating in the same frequency band.

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Open ADR Alliance

According to Open Automated Demand Response (Open ADR) Alliance, successful adoption of ADR requires standardization allowing wholesale electricity producers to communicate with utilities and aggregators, who, in turn, communicate with their customers, who can then decrease demand during peak hours. Without an ADR standard, automated DR would be problematic and expensive to implement. 

OpenADR is an open and standardized way for electricity providers and system operators to communicate DR signals with each other and with their customers using a common language over any existing IP-based communications network. As a member of Open ADR Alliance, TÜV Rheinland is working with standard development organizations, user groups, and other Smart Grid industry stakeholders to develop a conformance, certification, and testing program for OpenADR standard by employing existing standards from OASIS, UCA and NAESB. We will be able to perform Open ADR Testing in our Pleasanton CA location.


Topics: Electrical

Canada Approves SOR/2014-254 Products Containing Mercury Regulation

Posted by Bindu Subramanian on Thu, May 14, 2015 @ 09:45 AM

by Scott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

The effective date of this regulation is November 8, 2015

ChemicalsMercury also known as quicksilver is a heavy, silvery-white liquid metal. It is considered a highly toxic element that is found both naturally as well as through manufacturing use or disposal activities. While consumption of fish is considered to be the most significant source of ingestion related to mercury, coal-burning power plants, metal production, waste disposal, chemical production are also known to cause mercury poisoning. Studies and research has found that even minimal exposure to mercury can cause adverse effect to the environment as well as human health.

Several countries and government agencies have issued a ban limiting the use of Mercury. In 2008, the United States, ranked the world’s top exporter of mercury, introduced the Mercury Export Ban Act, implementation of which would remove a significant amount of mercury from the global market. Several other nations including EU and China has followed suit.

The most recent of such a ban comes from Canada. The Governor General of Canada, approved the SOR/2014-254: Products Containing Mercury Regulations under the Canadian Environmental Protection Act. The effective date of this regulation is November 8, 2015.


According to the SOR/2014-254, subject to section 2, these Regulations apply to any product that contains mercury and its compounds. The new regulation also provides a list of products that are exempt from this regulation, as long as they fall within the categories listed:

  • waste
  • a product that is at the end of its useful life and that is intended to be recycled
  • a food, drug, or cosmetic as defined in section 2 of the Food and Drugs Act
  • a veterinary biologic as defined in subsection 2(1) of the Health of Animals Act
  • a surface coating material as defined in subsection 1(1) of the Surface Coating Materials Regulations or a surface coating material applied to a toy regulated under the Toys Regulations
  • a pest control product as defined in subsection 2(1) of the Pest Control Products Act
  • a feed as defined in section 2 of the Feeds Act
  • a fertilizer as defined in section 2 of the Fertilizers Act
  • an explosive regulated under the Explosives Act
  • ammunition and explosives under the direction or control of the Minister of National Defense
  • a product, other than a battery, that has a mercury concentration of 0.1% or less by weight in homogeneous materials
  • a battery, other than a button cell battery, that has a mercury concentration of 0.0005% or less by weight in homogeneous materials
  • beginning on January 1, 2016, a button cell battery that has a mercury concentration of 0.0005% or less by weight in homogeneous materials
  • from January 1, 2016 until December 31, 2019, a button cell battery that is incorporated into a medical device that is intended to remain in the body for at least 30 consecutive days
  • ores, concentrates and by-products of metallurgic operations
  • an on-road vehicle as defined in subsection 1(1) of the On-Road Vehicle and Engine Emission Regulations that is of the 2016 model year or of a previous model year as determined under section 5 of those Regulations.

The regulation prohibits the manufacture or import of any product that contains mercury, unless the product belongs to the list of products specified in Column 1 of the schedule (see above bullets), the amount of mercury contained is within the specified limits, if the product is manufactured or imported before the end date set, or if the person holds a permit issued under subsection 5(1).

Mercury Periodic Table resized 600Labeling Requirements

The regulation also specifies Labeling Requirements. All products containing mercury or its compounds must be listed and should be clearly visible on the product and packaging.

  • The statement “Contains mercury / Contient du mercure”;
  • Safe handling procedures and the measures to be taken in case of accidental breakage, the address of a website where that information is available, or contact information for a person who can provide that information;
  • The options available for the disposal and recycling of the product in accordance with the laws of the jurisdiction where the disposal or recycling is to take place, the address of a website where that information is available, or contact information for a person who can provide that information; and
  • A statement to the effect that the product should be disposed of or recycled in accordance with the applicable laws.

The information must also appear in both official languages, and must be presented in a font size of at least 10 points with character that are at least 3mm in height, legible, indelible and are impressed, embossed or in a color that contrasts the label background or the color of the product. 

If the product is too small, or is not packaged, a notice must be attached to the product or the manual that accompanies the product with the relevant information.

Products containing mercury must ensure that the symbol Hg is indicated in the clearly specified font and size requirements in addition to it being legible and indelible.

Testing Requirements

Any determination of total quantity of mercury made for the purposes of these Regulations must be conducted by a laboratory that is accredited by a Canadian Accrediting body under International Organization for Standardization standard ISO/IEC 17025:2005 or a laboratory that is accredited under the Environment Quality Act, R.S.Q., c. Q-2.

Other significant features of this regulation include:

Any person that manufactures or imports a product that contains mercury other than the ones excluded, must submit a report to the Minister starting 2016 calendar year and every third calendar year after that year, on or before March 31 of the calendar year following the year in respect of which the report is prepared.

The new regulation will go into effect later this year, giving very little time for manufacturers or importers to comply. TUV Rheinland of North America is an ISO/IEC 17025:2005 accredited laboratory that can assist with determining total mercury in your product and developing a compliance path to comply with the requirement.

Contact us today for a quote or for more information!

Call us at 1-888-743-4652 | Email Us | Request Quote

Source: http://gazette.gc.ca/rp-pr/p2/2014/2014-11-19/html/sor-dors254-eng.php

Topics: RoHS/REACH, Green Services

What is an Industrial Control Panel?

Posted by Hope Mascott on Fri, May 01, 2015 @ 02:56 PM

Written by: Ryan Braman

What is an Industrial Control Panel?
According to the National Electric Code (NEC) 409.2, an Industrial Control Panel (ICP) is defined as “an assembly of a systematic and standard arrangement of two or more components such as motor controllers; overload relays; fused disconnect switches; and circuit breakers and related control devices including pushbutton stations, selector switches, timers, switches, and control relays, with associated wiring, terminal blocks, pilot lights and similar components.” 

Regulatory Requirements 
In the United States, Canada and the European Union, Industrial Control Panels (ICP’s) are required to meet a number of regulatory requirements including compliance to specified standards and listings. In the US, the ICP’s must comply with NEC Article 409 and section 110.3(B) and ANSI/NFPA 70. A panel without approvals which gets tagged by the local AHJ (Authorities Having Jurisdiction) can prove costly to a manufacturer.

Regulatory standards that are applicable to the ICP’s include:

  • UL508A (US)
  • CSA C22.2 No. 14 (Canada)
  • EN 60204-1 and EN 61439-1 (Europe)

Regulatory Challenges
Manufacturers mass produce as well as custom build ICP’s, making it very difficult and expensive to carry a typical listing or to utilize field evaluations for each panel. The goal of a manufacturer of ICP, especially when manufacturing a custom ICP, is to provide the most cost effective solutions based on client specifications. However, sometimes the best designed ICP’s are found to be non-compliant to regulatory requirements. A few reasons which have been cited for this non-compliance include: lack of consideration of panel application, component selection, and sometimes minor oversights.
Control Panel

How can TÜV Rheinland help?
by utilizing TÜV Rheinland’s panel shop program, manufacturers can now build ICPs and apply the widely accepted and recognizable TÜV Rheinland mark. This signifies to local AHJs that the panel meets the applicable safety standard for that location. Each label is serialized, allowing interested parties to verify the validity of the label using TÜV Rheinland’s Certipedia website. Our Panel Shop program offers shops the flexibility to produce a wide variety of custom panels without the necessity to evaluate each individual panel. When field evaluation and labeling services are required, TÜV Rheinland can offer next-day service to most locations in the U.S. and Canada.

Learn more about TÜV Rheinland's industrial control panel shop program.





Topics: Commercial, Industrial Control Panels

Bernard Hrubala Highlights TÜV Rheinland’s Roots as Keynote Speaker

Posted by Hope Mascott on Fri, May 01, 2015 @ 02:12 PM

In 1872, a group of engineers in the Elberfeld region of Germany banded together to create the "Dampfkessel-Überwachungs-Vereine" (DÜV), the first Steam Boiler Inspectorate, which was the immediate predecessor to today’s TÜV Rheinland.

Nearly 50 years later, in 1919, the National Board of Boiler and Pressure Vessel Inspectors was created here in the USA. The National Board promotes safety through uniformity in construction, installation, maintenance, and inspection of pressure equipment. In its nearly 100 year history, the American National Standard has been adopted by most states and cities, all Canadian provinces, and federal regulatory agencies including the US Department of Transportation. It is the only standard recognized worldwide for inservice inspection, repairs, and alterations of boilers and pressure vessels. 

Mr. Bernard Hrubala, global development manager for TÜV Rheinland AIA Services, was the Keynote speaker at the 2015 84th General Assembly of the National Board Boiler and Pressure Vessel Inspectors . The General Assembly , attended by nearly 600 Chief Inspectors and ASME standards development committee members from the USA, Canada, Japan, Korea, China, UK, Scotland, Italy, Russia, and South Africa  was held in conjunction with ASME Boiler and  Pressure Vessel Code Committee Meetings


Hrubala is an ASME governor who has given his entire career to the pressure equipment industry. In addition to ASME and NBIC, Mr. Hrubala has experience implementing the European Pressure Equipment Directive (PED), Indian Boiler Regulations (IBR), DOSH in Malaysia, SANAS in South Africa, and other international conformity assessment programs.

Speaking on the topic of ASME standards,Global Impact on Safety”  Mr. Hrubala outlined the original demand for safety standards such as ASME, citing several industrial accidents and fatal boiler explosions.

Currently, ASME codes and standards are accepted  in over 100 countries as a means of meeting regulatory requirements and  is  among the highest quality and safety requirements for industry, allowing for freer trade between nations. ASME standardization is expected to continue into the future, advancing public safety and the quality of life throughout the world.

 “It was a tremendous honor to be asked to keynote this year’s General Assembly ” said Hrubala, speaking from the meeting at Colorado Springs. “What we do has invisible benefits to millions of people worldwide : factories can continue running, oil and gas supplies can reach their destination safely, and power plants can generate uninterrupted electricity. Inspectors working under ASME standards make our world safer, and it was very gratifying to speak to my fellow inspectors about the work we love.

Topics: Industrial Services, TUV Rheinland

What's Behind the Listed Mark?

Posted by Hope Mascott on Mon, Apr 20, 2015 @ 11:05 AM

When Authorities Having Jurisdiction (AHJs) are out in the field inspecting equipment, they, no doubt, come across a wide variety of listed marks. Naturally, one or more of them are most familiar and so it makes sense that an AHJ inspector will look for them and question the validity of less well-known marks. However, listed safety marks are absolutely equal in their message and meaning.

UL, CSA, ETL and TÜV Rheinland listed marks are all valid certification marks demonstrating that a product has met the minimum requirements of widely accepted product safety standards. Each of these marks is issued by a Nationally Recognized Testing Laboratory (NRTL), an independent laboratory approved by the Occupational Safety and Health Administration (OSHA) to test products to the specifications of applicable safety standards. An NRTL's function is to provide independent evaluation, testing, and certification of any electrically operated or gas- and oil-fired product. (For more information about the NRTL program, visit www.osha.gov.)

All NRTLs, including TÜV Rheinland, can test products to a variety of the US and international standards, including UL standards. The misconception that UL is the only testing provider that can test to the UL standards might stem from the history of product safety testing in the US. At the start of its workplace safety and health program, the US government granted a testing monopoly to UL through the OSHA. In 1989, the US program was changed to a competitive model, and the role of an NRTL was created. The change came largely in response to pressure from the US industry groups whose members sold products in the European Union. Because of Europe's competitive regulatory market, in the early '80s, it was possible for US manufacturers to introduce their products to the European market twice as fast as they could introduce them to the US market.

The bottom line is that any NRTL’s mark is an accepted and recognized demonstration of product compliance. Any refusal to accept a specific certification mark could be considered a restraint of trade.

TÜV Rheinland is recognized as an NRTL in the US by OSHA, as a Testing Organization and Certifying Body by Standards Council of Canada, and as a Notified Body in Europe. The organization conducts evaluations to the UL, ANSI, CSA and NFPA standards as well as to the National Electrical Code and Canadian Electrical Code, andCanadian Electrical Code and SPE 1000 requirements.

TÜV Rheinland is a member of International Association of Electrical Inspectors, International Conference of Building Officials and American Council of Independent Laboratories.

To learn more about TÜV Rheinland mark, visit www.tuv.com/us, email info@tuv.com or call (888) 743-4652.


Topics: Commercial

New PAH Requirements for GS Certification

Posted by Bindu Subramanian on Wed, Apr 15, 2015 @ 10:15 AM

by Scott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

ChemicalsThe GS Mark is a voluntary certification mark that is used by manufacturers of consumer products of various kinds, and is accepted as the benchmark product safety certificate for exports to Germany. Effective 2008, the determination of the presence of Polycyclic Aromatic Hydrocarbons (PAH) in products is required in addition to the required safety tests. Although this is a voluntary standard, it has become the de-facto standard to limit PAH in all products exported to Germany. 

Effective 1 July 2015, a new set of PAH requirements under ProdSG will be implemented for all GS projects. This requirement was published by the German Committee for Technical Equipment and Consumer Products (Federal Institute for Occupational Safety and Health) in August 2014. The new AfPS document will replace the ZEK 01.4-08 as of 1 July 2015.

While the analytical test conditions remain largely untouched, the new requirements offer an entirely new set of specifications for PAHs. The new requirement has implemented the latest REACH Annex XVII (Item 50) Restriction of PAH for toys and other consumer products. The overall limits and categorization rule has been modified to further minimize the possible chemical hazards associated with these chemicals.

A quick look at some of the main changes:

  1. Change to Scope: Inclusion of all toys with intended or prolonged skin contact
  2. Increased limits in Category 1 for certain PAH’s
  3. Limits have been strengthened for products under Category 2 and 3.
  4. Timeline for compliance

Affected Product Categories

  • Electrical and electronic products 
  • Toys
  • Food packaging materials 
  • Plastic products 
  • Rubber products 
  • Machinery 


According to the new requirement, GS Mark certificates that are issued before July 1, 2015 will initially retain their validity. However, as a regular control measure to monitor the manufacturing process, if the product does not comply with the latest requirement at its next inspection, then the GS mark will be withdrawn immediately. Example, validity to the old requirement is to be transitioned between 1 year and 2 based on factory inspection frequency.

About PAH’s

Polycyclic aromatic hydrocarbons, also known as PAHs (and sometimes polyaromatic hydrocarbons) are a group of over 150 chemicals which are typically produced during the manufacturing process and are not intentionally added to consumer products. This group of structural substances are suspected to have or proven to have in some cases, carcinogenic properties. 

To read the detailed test limits, click here.

TÜV Rheinland can test and evaluate now to these stricter and more defined PAH concentration limits to prevent withdrawal of your current GS licenses due to non-compliance. Please contact us today for more details.

Contact us today!

Call us at 1-888-743-4652 | Email Us | Request Quote

Topics: RoHS/REACH, Green Services

Regulation (EU) 1272/2013 REACH amendment of PAH

Posted by Bindu Subramanian on Mon, Mar 16, 2015 @ 09:30 AM

by Scott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

REACH Regulation

Polycyclic aromatic hydrocarbons, also known as PAHs (and sometimes polyaromatic hydrocarbons) are a group of over 150 chemicals which are typically produced during the incomplete burning of coal, oil, gas and other organic substances. Some examples of PAHs include: naphthaline, anthracene, phenanthrene and pyrene. Most PAHs are considered carcinogenic, mutagenic and harmful to the reproductive system. They target fat tissues, the kidneys and the liver most often.

PAHs exist in a wide range of petrochemical products such as plastic, rubber, crude oil, lubricant, rustproof oil, form release agents, mineral oil and tar, and in daily chemicals such as pesticides, charcoal, germicides and mosquito-repellent incense. They can also be found in medicines and dyes. PAHs can also be man-made. Grilling or charring food at home, burning a wood fire or even breathing in cigarette smoke can expose you.

PAHs present a problem because they do not burn off easily, leading to a longer stay in the environment.  Although some can turn into a vapor in the air, most do not break down easily in water. Exposure to PAHs can occur with skin contact, ingesting of contaminated air or eating/drinking contaminated food or water, and they typically leave the body within a few days through feces or urine.

It’s estimated that exposure to 3 mg/day of PAHs will not cause any long-term health issues. However, studies have shown prolonged exposure over a significant amount of time might cause cancer and difficulties with reproduction. 

The Commission Regulation (EU) No 1272/2013 was published in official journal of European Union on 07 Dec 2013. This new regulation amended Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as regards Polycyclic Aromatic Hydrocarbons (PAHs). Under the REACH Regulation (EC) No 1907/2006 Annex XVII, Entry 50, eight PAHs have long been restricted in extender oils used in tires. The same eight PAHs are now subject to the new requirements added by two new paragraphs in the new regulation.

On December 27, 2015 The Commission Regulation (EU) No 1272/2913 will go into effect.

What to Know: Key Amendments

  • Articles with direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, made of plastic and rubber shall not contain more than 1 mg/kg (0.0001 % by weight of this component) of any of the listed PAHs
  • Such articles can include:
  • Sport equipment such as bicycles, golf clubs, racquets
  • Household utensils, trolleys, walking frames
  • Tools for domestic use
  • Clothing, footwear, gloves and sportswear
  • Watch-straps, wrist-bands, masks, head-bands
  • Toys, including activity toys, and childcare articles, shall not contain more than 0.5 mg/kg (0.00005 % by weight of this component) of any of the listed PAHs.

Name of PAH


Name of PAH


















Are you ready to comply with the new amendments?

Per the European Chemicals agency, “A restriction applies to any substance on its own, in a mixture or in an article, including those that do not require registration. It can also apply to imports.”  This new restriction means that your products that contain plastics or rubbers that are to be touched under normal use cannot have more than 1 mg/kg (0.0001 % by weight of this component) of any of the listed PAHs.  Analysis to confirm the content is imperative to prevent removal or banning of your products.  As this takes affect December 27, 2015, time is short and action may be required on your part to reformulate or substitute components.

TÜV Rheinland can test for these substances now.  Be proactive and contact us to prevent a hindrance to the EU market.

TÜV Rheinland is committed to offering you the latest updates in REACH. Our experts can offer you up-to-date information and recommend relevant test. Please contact us today for more details.

SOURCE: Commission Regulation (EU) No 1272/2013 Official Document

SOURCE: http://www.epa.gov/osw/hazard/wastemin/minimize/factshts/pahs.pdf

SOURCE: http://www.atsdr.cdc.gov/PHS/PHS.asp?id=120&tid=25

Topics: RoHS/REACH, Green Services

4th Edition of IEC 60601-1-2 Sets New EMC Requirements

Posted by Bindu Subramanian on Tue, Feb 24, 2015 @ 09:00 AM

by Bruce Fagley, TÜV Rheinland, EMC Technical Manager


IEC 60601-1-2

The fourth edition of the IEC 60601-1-2:2014 standard is out, introducing significant technical changes in electromagnetic compatibility (EMC) requirements and tests for medical equipment and systems. The revision mandates compliance of new products by April 2017 in the USA. In the European Union, the 4th edition is not yet published in the official journal so the mandatory date of compliance is not clear.  It is possible that this date may be set at August 2017, more information will be available in a few months. In the USA, existing products will need to comply if changes are made, effective, April 2017. The US Food and Drug Administration (FDA) already officially accepts the fourth edition, and there have been reports that the FDA is asking for it now on new 510(k) applications.

The main goal of the new edition is to ensure that the practice of science, medicine, and saving lives is not disturbed by common EMC phenomena.

Here are some key specifics:

  • The fourth edition changes the basic EMC compliance philosophy to define tests and limits according to risk and intended use instead of a device type. Tests are defined based on where the equipment will be used – either in a healthcare facility, at home (which includes almost everything except the healthcare environment) or in a special environment such as military, heavy industrial, or medical treatment area with high-powered medical equipment and will be tested in accordance with its intended use.
  • The revision recognizes that for special environments, immunity test levels higher or lower than those specified for the professional healthcare and home environments might be appropriate.  As an example, a product that is always used in a humidity controlled environment may be allowed to meet lower ESD immunity levels.
  • The edition introduces new safety engineering into medical EMC/ Risk Management. The title of the standard is now “General requirements for basic safety and essential performance.”  The product risk analysis must now include risk from EMC disturbances.
  • Products will be subjected to increased immunity test levels to minimize the risk of electromagnetic interference: for example, the ESD test levels are increased to 15KV air and 8KV contact, almost double the current specifications. The levels of conducted immunity testing are now increased to 6v in the ISM frequency bands.
  • Another significant change from the existing requirements is the new wireless proximity test, which increases the radiated immunity test levels to 28V/m at some frequencies. These levels are increased to evaluate the products susceptibility to interference from common wireless devices.  All products must comply with the new test.
  • The standard restricts the use of lower immunity levels for compliance. The new annex “E” describes the process for determining the immunity test levels for products used in special environments where different immunity levels could be justified.
  • Manufacturers will need to prepare a test plan/risk analysis prior to testing. Clause 6.2 requires that an EMC test plan be provided to the EMC test lab, additional guidance on preparing a test plan is found in annex “G” of the standard.

Advance planning is critical for compliance, especially if a manufacturer has multiple products, all of which will eventually need to be re-tested to the new requirements.  Manufacturers are advised to review the design of their products now to determine if any changes will be required to ensure timely compliance. The manufacturer must be aware that when developing the risk analysis, all EMC risks present in the environment of use must be considered.  This may require testing to additional EMC standards like IEC 61000-4-16, MIL-STD 461 etc. 

TÜV Rheinland's expert services can help you take advantage of everything IEC 60601-1-2:2014.  Starting your transition early allows you to ensure your medical device safety testing will comply with standards worldwide, and reduce the risk of company liability by meeting approved safety standards.

Contact us to get a head start in your transition process and reap the hidden benefits of IEC 60601-1 Standard.

Topics: EMC, Medical, IEC 60601

Green Blog Series: What’s changing in China RoHS?

Posted by Bindu Subramanian on Wed, Feb 18, 2015 @ 01:30 PM

TUV Rheinland of North America is excited to annouce our 2015 Green Blog Series. TÜV Rheinland experts and industry veterans, Geoffrey Bock and Scott Sagamang will be presenting you with a new timely blog each month on the most up-to-date "Green" topic.

Meet our experts!

Scott SagamangScott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

In his current role, Sagamang specializes in assisting companies with global environmental requirements. His background includes extensive experience with machinery manufacturing, retrofitting, machine control and machinery safety. 

He has extensive knowledge on EU RoHS, WEEE, China RoHS, EU REACH, PAH, LFGB, XRF and Chemical Analysis, CalProp65, CPSIA as well as product lifecycle management.

Geoffrey Bock

Geoffrey Bock, Director - Green and Environmental Services, TUV Rheinland of North America.

A 15 year veteran of TÜV Rheinland, Geoffrey is intensely involved in educating and training manufacturers on the RoHS, REACH and WEEE directives. 

He is a “Substances of Concern” task group leader for the NSF 426 ELSS (Environmental Leadership Standards for Servers) standard development committee. His experience in manufacturing, supply chain sustainability and a broad knowledge of environmental restrictions helps customers understand the hurdles they have to navigate through in order to prove compliance. He often provides training and seminars for clients globally.

Our first installment in our monthly blog series is on the current changes to China RoHS!

REACH ChemicalsDid you know that a revised marking standard was implemented on January 1, 2015?  SJ/T 11364-2014-2006 is now replaced by SJ/T 11364-2014.  The new title of the standard is “Marking for the Restricted Use of Hazardous Substances in Electronic and Electrical Products”.

Let’s take a look at the comparison of the major changes between the 2006 version and the 2014 version as cited in the English version:

  • Most noticeable update is a name and applicable scope changes.  “Electronic information products” is now changed to “electronic and electrical products”.  Also “pollution control” has been changed to “restricted use of hazardous substances”.
  • An explanation for the reference application in logistics processes has been added.
  • Reference to Chinese Standard GB 18455 has been deleted from the standard
  • Definitions and terms for “electronic and electrical products”, “hazardous substance”, and “logistics” have been added.
  • Also, digital format options have been added for electronic and electrical products with display functions.
  • Deletion of the name labeling requirements for packing materials.
  • One should also note that EEP (electronic and electrical products) now have rated working electrical voltages limitations for both AC and DC.
  • A section that specifies the conditions that must be met if using the digital format mark.
  • The clause 6.2 table has a new reference to the option of adding an explanation of when you choose to add “X” for a particular part name and hazardous substance.

RoHS label resized 600As you might notice, the Chinese standard is starting to look more and more like something you would see as part of EU RoHS.  There is discussion of the scope of products  may be moving to a similar product scope as seen with EU RoHS.  The ministry law has not officially been updated, thus the standard is said to be in abeyance until that time.

Now is the time to understand what this can mean for your products.  Realize that this could happen at some point in the near future.  It is not uncommon for the new law to be implemented without notice.  If the product scope changes and you must comply, can you react quickly?  Do you have a solution to implement this quickly without loss to market?  TÜV Rheinland is a service provider that can react quickly and assist with providing the due diligence you need to prevent product flow stoppage.

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Topics: RoHS/REACH, Green Services