by Bruce Fagley, TÜV Rheinland, EMC Technical Manager
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.
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 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, Senior Business Development Manager - 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!
Did 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.
As 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.
Contact us today!
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On December 17, 2014, the European Commission notified the World Trade Organization (WTO) that it will be adding four additional substances to the EU RoHS Directive (2011/65/EU). This will be done as a Delegated Directive amending Annex II (list of restricted substances) of the RoHS Directive.
Four phthalate substances will be added to the RoHS substance restrictions. Phthalates are primarily used as plasticizers in plastics, particularly in PVC plastic which is commonly used for wires and cables but can also be found on some electronic components or other plastic parts.
The restrictions take effect beginning on July 22, 2019 and most products will need to comply including medical devices, by July 22, 2021. Click here to read the release in detail.
It is expected that the additional 4 Phthalates added to the RoHS Directive will add stress initially to supply chain management, as new declarations of conformity for their part numbers will be required.
Risk assessments and testing of high risk parts will be required according to EN 50581 (RoHS – Technical Construction File requirements)
TÜV Rheinland is committed to offering you the latest updates in Green Compliance (REACH, RoHS and WEEE). Our experts can offer you up-to-date information and relevant test. Please contact us today for more details and our service offers.
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TÜV Rheinland’s Environmental Health and Safety solutions bring qualified engineers, industrial hygienists, and occupational safety experts to your facility to ensure your operations and equipment meet Federal and State OSHA plans, NFPA standards, and ANSI or other applicable consensus standards and best practices.
In the year 2014, we saw several changes and revisions to workplace safety laws. Our experts wrote several timely blogs to keep you informed of these changes!
TÜV Rheinland's EHS Safety Resources
If you missed any of our blogs on Occupational Health and Safety, please click on the links below to read them!
Let TUV Rheinland of North America work with your team to help identify and eliminate or minimize occupational health hazards. Contact us today!
On December 17, 2014, The European Chemicals Agency (ECHA) amended the Candidate List by adding six (6) new substances to the REACH Candidate list, bringing the total up to 161 substances. The following substances meet the criteria set out in Article 57 of the REACH Regulation.
DEHP is now updated to reflect the additional reason for inclusion. Click here for more information on the newly added substances.
TÜV Rheinland is committed to offering you the latest updates in REACH. Our Chemical expertise can offer you up-to-date information and relevant test. Please contact us today for more details and our service offers.
Original Equipment Manufacturers (OEM’s) are constantly demanding full material disclosures on hazardous substances (FMDs), Declarations of Conformity (DoCs), Certificates of Conformity (CoCs) and/or test data that the part numbers meet the required RoHS or REACH requirements. This is the method by which most OEM’s declare compliance for their finished product.
Several countries globally are implementing Restriction of Hazardous Substances (RoHS) regulations and REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations in order to restrict the use of harmful chemicals and toxins in their electrical and electronic products.
Regions that have stringent rules at this time include:
- European Union / RoHS Directive
- China / Administration of the Control and Electronic Information Products or commonly referred to as China RoHS
- Korea / Administration of the Control and Electronic Information Products
- California / (Electronic Waste Recycling Act of 2003)
- and more….
Products intended to be marketed or sold in Europe MUST
comply with REACH and RoHS regulations.
What is RoHS?
RoHS is the EU Directive that restricts the use of certain hazardous substances in electrical equipment and electronic products (EEE products), including components and/or sub-assemblies.
Who does RoHS affect?
Any business that uses any of the restricted materials and plans to sell its products in RoHS countries, through any sales channel (direct, distributor, integrator, reseller etc.), is affected by the RoHS Directive. Failure to comply with the RoHS regulations can result in severe fines and could result in immediate removal of product from the EU marketplace.
Since 2004, the EU legislation restricts the use of hazardous substances in electrical and electronic equipment (RoHS Directive 2002/95/EC) and promotes the collection and recycling of such equipment (WEEE Directive 2002/96/EC). Products placed on the EU market as of July 1, 2006 must pass the RoHS Compliance.
The objective of the legislation was also to increase the recycling and/or re-use of such products and restrict the use of heavy metals like lead, mercury, cadmium, and hexavalent chromium, as well as flame retardants such as polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE).
In 2011, the EU amended the RoHS scope, also known as RoHS2. The recast European RoHS Directive (2011/65/EU), restricts the use of certain hazardous substances in electrical and electronic equipment. The recast directive repealed the Directive 2002/95/EC with effect from 1 July 2011. The EU has also released an exemptions update, allowing the use of some of the restricted chemicals for specific purposes. (Click here to read more)
RoHS II is also a CE Mark Directive, effective January 2, 2013 and the transition is expected to be complete in 2019. The directive applies to products that are “dependent on electric current or electromagnetic fields for at least one intended function”.
- Technical testing and accompanying documents
- A declaration of conformity
- CE marking affixed to the product.
Similar to the RoHS requirements, the EU REACH regulation is also mandatory for products being exported to Europe.
What is REACH?
Registration, Evaluation, Authorization and Restriction of Chemicals or REACH is considered to be the strictest law to date regulating the use of chemical substances. REACH is a European Community safety regulation that implies that "no data, no market" companies can only launch their products on the market or use them if these chemicals are properly registered. EU REACH started its 10 year, phased implementation on June 1, 2007. The current REACH regulation for “articles” includes 155 substances of very high concern (SVHC’s). For a complete list, please click here.
One of the major elements of the REACH regulation is the requirement to communicate information on chemicals throughout the supply chain. The REACH regulations affect manufacturers, importers, downstream users and companies established outside the EU. The end use of chemicals affect various industries from consumer goods to personal care to industrial use. Here is a short list of some other industries affected:
- Chemical Industry
- Petroleum Processing
- Plastics Processing
- Engine/Plant Production
- Fine Mechanics
- Sports Equipment
- Leather and Drapery
The European Chemicals Agency has set three major deadlines for registration of chemicals:
- December 1 2010 - 1000 tons/year
- June 1, 2013- 100 tons/year
- June 2, 2018 - 1 ton/year
Pre-registration is the process for potential EU registrants to inform the European Chemicals Agency (ECHA) of their intent to register phase-in chemical substances. The EU REACH Pre-Registration initially took place between June 1 and December 1, 2008, during which time about 143,000 chemical substances marketed in the European Union were pre-registered. The pre-registration was later extended to potential registrants who manufacture or import a phase-in substance in quantities of one ton per year or more to benefit from the extended deadlines. Click here to read our blog on this topic.
Similar to RoHS, even if you don't do business in Europe, you are not off the hook. Following the EU regulation, countries such as China, Malaysia, Japan, and Turkey have already implemented REACH-like legislation. Several other countries are following suit including South Korea which will unveil its REACH regulation “K-REACH” in January 2015.
TÜV Rheinland’s Green Solutions Goes to Work for You
REACH and RoHS compliance poses a big challenge for most companies and requires extensive and specific technical competence and knowledge.
We want to be your partner in ensuring your materials and parts are in compliance. We will assist you with risk assessment of materials, identifying potential high risk materials requiring testing and/or help with validating DOCs and CoCs. Our test lab in North America is ISO 17025 approved through A2LA, accredited for many types of material and product testing and is located in Bentonville, Arkansas.
We employ RoHS, REACH, CPSC, WEEE and other legislation experts that can assist you with your educational needs as well as consult on compliance requirements and solutions. To learn more click here to download our complete brochure or our handy infographic!
Boston recently played host to an international crowd of innovators, public officials, patient groups, academics and entrepreneurs with a vested interest in Connected Health. They gathered at the 5th EU-US eHealth Business Marketplace & Conference held at the Boston State House on October 21-22.
The conference focused on innovations in e-Health, IT Health and Connected Health, a model for healthcare delivery that uses technology to provide healthcare remotely. The theme was “Transforming Care and Accelerating Economies.”
TÜV Rheinland’s Geoffrey Bock and OpenSky’s Mark Coderre attended the conference to learn from the international leaders in Connected Health and share their own expertise as part of the panel on “Medical Device Suite of Standards – to What Degree Does Regulation Help or Hinder Innovation?”
Coderre discussed the ever-increasing need for cybersecurity in embedded in the development lifecycle and final product for medical devices. He also reviewed and acknowledged the importance of the principles laid out in the FDA's guidance in the United States. Bock explained the need for risk assessments that help OEMs meet the standards applicable to the current EU Directives.
“Regulations, standards, risk assessments and due-diligence all help keep patients, doctors, clinics and insurance companies safe when they accept new and innovative devices that might pose high risk precisely because they are so groundbreaking,” summarized Bock.
The conference provided workshops, networking with IT Health professionals, and the chance to establish new business relationships in pre-arranged matchmaking sessions. The partnership between Ireland and the US is particularly promising and was highlighted through a direct “Sister City” relationship between Belfast, Ireland, and Boston.
“It was great to see how many countries were present at this show, and the relationship that Boston has with Belfast was clearly evident through the number of representatives,” said Bock. “It was a great message to other countries that working together across the Atlantic is not only possible but very rewarding.”
The “Shark Tank” session, which allowed innovators to present their ideas in search for funding, showcased some unique offerings, most of which, used phones, tablets and apps to provide the new product, confirming the trend toward using Wi-Fi, 3G/4G and Bluetooth technologies in medical innovations.
To learn more about testing of Connected Health devices, email TÜV Rheinland at info@ tuv.com.
On November 28, 2013, a list of Machinery Directive harmonized standards was published in the Official Journal of the European Union (OJ). These harmonized standards provide a presumption of conformity to the Machinery Directive 2006/42/EC and the new list of standards supersedes all previous versions. The list of standards was further divided into A-type, B-type and C-type standards.
Outdoor power equipment manufacturers, designers, distributors and retailers of lawnmowers doing business in international markets need to be aware of the changes in regulatory compliance requirements for lawnmowers and turf care equipment. EN ISO 5395-based standards replaces the EN 836-based standards on September 30, 2014, and are categorized under the C-type standards.
The three parts of EN 5395 standards are as follows:
- EN ISO 5395-1:2013 Garden equipment - Safety requirements for combustion-engine-powered lawnmowers - Part 1: Terminology and common tests (supersedes EN 836:1997+A4:2011)
- EN ISO 5395-2:2013 Garden equipment - Safety requirements for combustion-engine-powered lawnmowers - Part 2: Pedestrian-controlled lawnmowers (supersedes EN 836:1997+A4:2011)
- EN ISO 5395-3:2013 Garden equipment - Safety requirements for combustion-engine-powered lawnmowers - Part 3: Ride-on lawnmowers with seated operator (supersedes EN 836:1997+A4:2011)
EN 836 specified the requirements and verification means for pedestrian-controlled, ride-on and lawn/garden tractors with mowing attachments, including professional machines. It excluded lawn trimmers, scrub cutters and rotary mowers with non-metallic cutters with KE not greater than 10 Joules. According to the European Standards Commission, the EN 836 standard ceases to give a presumption of conformity on September 30 2014 and the EN ISO 5395-based standards (EN ISO 5395-1:2013; EN ISO 5395-2:2013, EN ISO 5395-3:2013) will be given the status of a national standard.
The revised EN ISO 5395:2013 -1 safety standard series provides design requirements and test procedures required to achieve a valid presumption of conformity with the Essential Requirements of Directive 2006/42/EC and associated EFTA regulations.
Some of the major changes driven by the EN ISO 5395-:2013 standards include:
- Updates Technical Construction Files and Declaration of Conformity documents
- No mow in reverse
- Impact Test
- Parking and service brake actuation
- Test Equipment Requirements
- Cutting means transport
- Electromagnetic Immunity
- Operator Presence Control
- Artificial Weathering Test
For more information on the changes to these items, be sure to download our whitepaper: Are Your Mowers Up To Speed with EN 5395:2013 Requirements?
Product safety and regulatory compliance is a critical issue for manufacturers of home and garden products. Domestic and international distribution channels as well as end-users demand safety, reliability and rigorous compliance to existing and emerging standards. In addition to the EN 5395-based standards, TÜV Rheinland also provides certification in accordance with B71.4 and B71.1 standards.
B71.1 specifies the safety specifications of Consumer Turf Care Equipment – Pedestrian-Controlled Mowers and Ride-On Mowers. This standard applies to reel and rotary walk-behind power lawn mowers, reel and rotary ride-on power lawn mowers, ride-on power lawn tractors with mower attachments, ride-on power lawn and garden tractors with mower attachments, and lever steer ride-on mowers intended to apply to consumer products for personal use.
Safety specifications outlined in B71.4, US Commercial mower standard, apply to powered pedestrian-controlled, towed, and ride-on machines intended for marketing as commercial turf care equipment and that are customarily used by hired operators, and to all aftermarket parts, attachments and accessories provided by the original equipment manufacturer and others.
Call us today to see if your mowers comply with the changes driven by the new EN ISO 5395.
If you are attending the GIE+EXPO show October 23-24, 2014 in Kentucky, consider meeting with a TÜV Rheinland expert during the show. We can help you understand what you need to do be in compliance!
To what degree does regulation help/hinder innovation?
More than 250 attendees representing many facets of the healthcare industry will be attending the two day Connected Health Conference. These cutting edge workshops will include:
- Overcoming Barriers to Deployment of Health at Scale
- Building the Economic Bridge Through Connected Health Ecosystems
- Biosimilars, Cloud Computing Research and Risk Stratification
- Patient Portable Data
- Connected Health Simulations Rather Than Trials
- And more...
Chad Schieken, Regional Practice Leader, Security, OpenSky and Geoffrey Bock, Senior Business Development, Environmental Services, TUV Rheinland will be participating on a panel on the topic of Medical Device Suite of Standards – to what degree does regulation help/hinder innovation? This panel will be held at 2:45pm on Wednesday, October 22, 2014.
EU-US eHealth Marketplace and Conference
Massachusetts State House
Tues. October 21—Wed. October 22
||Geoffrey Bock is the Senior Business Development Manager for Green and Environmental Services at TUV Rheinland. He is currently involved in developing business for Green Services including RoHS, REACH, WEEE, Certification, and 3rd Party partnerships to provide a full range of Environmental Services to our clients. He recently joined the NSF 426 Environmental Leadership Standard for Servers and is the Task Group Leader for “Substances of Concern.” He often provides training and seminars for clients nationally and globally.
||Chad Schieken is a Regional Practice Leader/Security at OpenSky. is an innovative executive and experienced compliance professional managing and delivering services focused on information security, privacy, and internal control. Chad has deep knowledge of various legal, regulatory, and industry requirements and is highly effective in business development settings. He has over 20 years of professional experience in information security in a variety of settings. His primary areas of expertise include risk assessment and analysis, privacy, compliance, vulnerability management, merger and acquisition risk management, security policy, and security awareness training. Chad has in-depth experience with various audit standards, compliance requirements (PCI DSS, HIPAA, GLBA, and FISMA) and practical knowledge of various technologies.
Click here to register for the conference.
The average wait time for Testing of Gas Detectors in the U.S. can take from anywhere from 4 to 6 months. This means a significant delay in time to market and even delayed revenue for North American manufacturers.
In an effort to help North American gas detector manufacturers dramatically reduce their time to market, TUV Rheinland of North America will now offer IEC 60079-29-1 certification services.
The IEC 60079-29-1 standard specifies the general requirements for construction, testing and performance, and describes the test methods that apply to portable, transportable and fixed apparatus for the detection and measurement of flammable gas or vapor concentrations with air.
In collaboration with our labs in Cologne, we can now start your test within a two-to-four-week period. Our expanded facility in Cologne is equipped with state of the art equipment. Our experts are knowledgeable with all the regulations and directives you need including IEC/EN 60079-29-1, to get your products to market.
Click here to read the press release on this new service.
TÜV Rheinland provides IECEx Certification, ATEX and HazLoc Testing, EMC Testing, Functional Safety and Machinery Safety.
Contact us today for lab availability, or other ways we can help you meet your testing needs!
Contact TÜV Rheinland
(888) 743-4652 |email@example.com
Image Courtesy: Image used with permission from Honeywell