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RoHS 2 for Medical - Are You Ready?

  
  
  

The July deadline for compliance with the new RoHS2 2011/65/EU Directive has passed. Are you ready?

  • July 2014: Medical Electrical and Electronic Equipment falling under the MDD 93/42/EEC
  • July 2016: In Vitro Diagnostic Electrical and Electronic Equipment under the IVD 98/79/EC
What you Need to Know

What is RoHS 2?
The 2011/65/EU (RoHS2) Directive is a recast of the 2002/95/EC Restriction of Hazardous Substances Directive and now includes electrical and electronic Medical, IVD and Monitoring & Control Instruments.

Are there any changes to restricted substances?
No. Lead, Mercury, Chromium VI, PBBs & PBDE’s remain at 0.1%. Cadmium remains at 0.01%

Are standards available to help me demonstrate conformity to the requirements?
The EN 50581 standard was created to assist OEMs in
complying with the new RoHS2 directive. This standard
includes tasks for developing the Technical Construction File, performing risk assessments on materials and suppliers, and recommended documentation to obtain from vendors.

What does the CE Mark cover?
The CE mark on your equipment now means that you fully comply with not only the MDD or IVD Directives, but also the RoHS Directive.

How can TÜV Rheinland Help?

  • Assist with Supplier/Material Risk Assessment and completing the Technical Construction File (TCF) using EN 50581
  • Software Management of Environmental supplier data and test results
  • RoHS2 Ready Audits with Gap Analysis
  • BOM Analysis & Scrubbing with Supplier Data Collection
  • WEEE Recycling and Recovery Rates Reports
  • Chemical Testing (RoHS, REACH, and many other standards)
  • Non-Destructive XRF and HD-XRF Testing
  • REACH Registration and Compliance Dossiers
For more information or to find out how TÜV Rheinland can help you, contact us today!
Phone: 1-888-743-4652 | Email Us

OpenSky, TÜV Rheinland Company, Expands IT Infrastructure and Cybersecurity Services With Location in United Kingdom

  
  
  

OpenSky, an IT consulting firm focused on securing information assets and transforming IT infrastructure, has today announced the opening of its first regional office in the United Kingdom. A TÜV Rheinland Company, OpenSky provides access to a global network of resources. The new office, located in Leatherhead, England, is part of an international strategy that will enable OpenSky to better serve its clients by providing local experts to solve complex IT challenges.

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 OpenSky has completed over 750 IT projects to help  major enterprises, many on the Fortune 500 list, find  solutions for their most pressing challenges. Through  a unique, vendor-independent perspective,  OpenSky’s team of seasoned professionals focus on  delivering solutions that are tailored to the client’s  specific maturity and IT environment.

 “Our operations in the United States, the largest  market for IT services and security solutions, have  provided us with long-term, valuable relationships  with clients in the Fortune 500 group,” said Roger  Levasseur, President and CEO of OpenSky. “We have  established ourselves as a trusted adviser, and it is a  logical next step to improve our international support  by providing local resources and expertise.”

Matthew Wiltshire has been appointed to lead OpenSky’s UK operations as Managing Director. He has managed IT service businesses in the UK for over 15 years and brings his years of firsthand experience to OpenSky to help guide clients as they face rapidly evolving pressures.

“Many large enterprises in the UK are facing increased concern about the threat of cyber attacks and the need to design highly secure, leading-edge transformational infrastructure solutions,” said Wiltshire.

 Read the entire press release 

 

 

Ask the Experts---Materials and Tensile Testing Webinar on July 30th

  
  
  

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Presented by Brett Pond and Christopher Nichol, this webinar will cover Tensile Testing & Metallurgical Services.


TÜV Rheinland Industrial Solutions (TRIS), a full-service inspection, testing and certification company, recently expanded the range of tensile and compression load test capabilities with its hydraulic machine calibrated from 10,000 lb. to 1 million lb. of pressure.

Hear about our new capabilities at the Metallurgical lab in this brief webinar presented by our licensed metallurgical and mechanical engineers. They will provide an independent expert opinion on a variety of projects including component failures, material quality, and accident reconstruction and manufacturing processes.

What you will learn:

  • Tensile & Compression Load Test Capabilities
  • Non-Destructive Testing
  • Mechanical Testing
  • Failure Analysis, Physical Testing, Machine Design, Computational Modeling
  • and more...

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Event Details:

Wed. July 30th

2:00pm ET/11:00am PT

 

Register Today!

 

Grand Opening in Aliquippa PA -- August 29th

  
  
  
TÜV Rheinland is excited to welcome our customers to the Grand Opening Celebration of our new Aliquippa Metallurgical Lab in PA. 

Join us and tour our labs, attend demo sessions to get a first hand look at our Metallurgical Lab, Materials Testing and Non-Destructive Testing Lab and, our Field Service Mobile Lab.

describe the imageEvent Details:  

Date: Friday, August 29, 2014

Time: 10:00am--2:30pm

Location: 100 Industrial Blvd, Aliquippa, PA 15001

 

Agenda:

We will be conducting three (one hour) lab tours and demo sessions starting at 10:30am. Attend one or all three until 1:30

  • Metallurgical Lab Tour
  • Materials Testing and Non-Destructive Testing Lab Tour
  • Field Service Mobile Lab Tour and Demo

Join us at 1:30 for a complimentary lunch and meet the team!

Register today!


Award given to TUV Rheinland Bentonville AR Office

  
  
  

Mark Smith, Laboratory Manager at TUV Rheinland in Bentonville AR accepted an award from Tony Warrington, Technical Director at Mississippi Polymers, Inc., on behalf of TUV Rheinland's Bentonville, AR office. The company manufactures calendered PVC film and sheeting and value-added prints and laminates.

Mississippi Polymers participates in many local and community fund raisers throughout the year. The company strives to be an important part of not only the community but also the employes and the things that affect their lives.  In the past, the company has played a major role in funding research to find a treatment and cure for polycystic kidney disease.

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The MVP award is for the company service provider that has gone above and beyond to deliver critical services over the past year. According to Mississippi Polymers VP of Sales & Marketing, Jerry Waxman, “CPSIA compliance has become a very important part of our business and TUV Rheinland's ability to turn results quickly helps immeasurably.”

The Criteria for earning the MVP award:

  1. Executives at Mississippi Polymers review the prospects for consideration.
  1. The evaluation is based on Price, Quality, Service/Delivery and Dependability.
  1. What is the overall value that their company has added to Mississippi Polymers throughout the year?

TUV Rheinland tests vinyl film and laminate product for Mississippi Polymers for select chemical attributes such as phthalate and heavy metal content. Mississippi Polymers selected TUV Rheinland because of the quick dependable and reliant service was one that added great value to Mississippi Polymers.  It allowed the company the ability to quickly release material to customers for shipment thereby keeping the supply chain open and moving.

Delayed inventory moves, equal lost dollars. Much of the testing from Mississippi Polymers Inc is required on a next day service basis and TUV Rheinland has never missed a report deadline in over 2 years of work with the company.

The supplier dinner was held June 18, 2014 in Memphis, TN

 

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TÜV Rheinland Introduces Cybersecurity Services for Medical Devices

  
  
  

CybersecurityThe Federal Drug Administration (FDA) announced cybersecurity guidelines for medical devices. The need for effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information.

As threats increase, individuals and companies are finding themselves scrambling to understand this emerging threat and prepare to respond. The best way for manufacturers to do that is to integrate cybersecurity solutions during the early stages of product development and document the assessment and remediation’s performed.

TÜV Rheinland is now offering cybersecurity services, including: vulnerability assessment analyses, penetration testing and software source code analysis. The program will also help manufacturers meet healthcare provider purchase requirements, reduce risks, protect company brand and reputation, and get products to market faster.

The introduction of these services, coupled with TÜV Rheinland’s traditional product testing and certification means that TÜV Rheinland can now offer a complete solution to medical device manufacturers.

For more information on cybersecurity services read our press release, or visit our website.

Ask the Expert--Inverter Testing & Certification Webinar

  
  
  

Join Paul Morton on July 22nd at 2:00pm ET, 11:00am PT, when he provides an overview of inverter testing & certification. This is the first of six webinars.

You will learn about:


• Basic definitions-Inverter types

• Overvoltage

• Pollution degree

• Grid tied operation

• Stand-alone operation

About the Presenter: Paul Morton

Mr. Morton is an Engineer in the Solar and Fuel Cell Division of TUV Rheinland and is a Professional Engineer in the Province of Ontario, with over 25 years experience in product safety testing and evaluation. He is an active member on CSA Committees on standards related to inverters. He has extensive experience in the testing and evaluation of switch mode power supplies and inverters.
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   Paul Morton, Over 25 years experience in product safety will present on July 22nd

Register Today!

TÜV RHEINLAND OPENS NEW METALLURGICAL TESTING LAB IN ALIQUIPPA, PENN.

  
  
  

Company Expands Metallurgical Testing Capacity, Offers Custom Tests to Better Serve Clients

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Aliquippa, Penn., June 26th, 2014 – TÜV Rheinland Industrial Solutions expanded its metallurgical testing and engineering consulting services by opening a new laboratory in Aliquippa, Pennsylvania. The expansion is in response to a growing customer demand and will allow TÜV Rheinland to provide a complete range of services from the existing Aliquippa facility, which also offers non-destructive and mechanical testing services.

 

Specifically, metallurgical services offered at the new lab include microstructural analysis, failure analysis, chemical analysis, fatigue testing, engineering design, finite element analysis (FEA), and expert witness opinions and testimony. In addition to providing standard metallurgical and mechanical testing services, TÜV Rheinland has the capability to design and perform custom tests to better serve clients’ needs.

 

“There was a lot of synergy between the metallurgical and existing Aliquippa mechanical test services, so it was a logical decision to combine them and provide a complete service portfolio from one location,” said Brett Pond, Principal Metallurgist at TRIS.

 

Pond will manage the new lab, located at 100 Industrial Boulevard, Aliquippa. He holds a Doctor of Science (DSc) in the discipline of Mechanical Engineering from Washington University in St. Louis, Mo., and manages projects that involve finite element modeling, machine design, failure analysis, and materials testing, characterization and selection. Pond can be reached directly at

 

A subsidiary of TUV Rheinland North America, TRIS is ISO 17025 certified and Nadcap accredited. TRIS also offers the metallurgical services in Omaha, Nebr.

 

To learn more about TRIS’s new lab, call (724) 378-3900 or visit www.tuvris.com.

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Danger in the Workplace – Automated Material Handling

  
  
  

Danger in the Workplace – Automated Material Handling
By Jonathan Kotrba – Director of Commercial Products

Ten years ago, the majority of our purchases were made directly in brick and mortar stores. Today, the sales distribution channel for consumer purchases has significantly shifted toward internet shopping, with the trend extending into perishable food items. The increase in online retailing has led to the rise of order fulfillment warehousing and a shift in work force to these facilities, which operate more as factories rather than the department stores they are replacing.

Both equipment and process in warehouse fulfillment centers present certain dangers. Automated material handling systems, conveyor belts, lifts, and associated machinery all pose risks that were not present in the traditional retail industry. In addition, the need for faster and more efficient operations places pressure on staff and management to cut corners, which could potentially impact safety. This environment, coupled with seasonal and temporary workforces, has led to a greater exposure of risk for injury than what was traditionally experienced in department stores. A measure of this risk is the injury rate data presented by the US Department of Labor, Occupational Safety and Health Administration. The OSHA’s recordable “incidence rate” represents the number of injuries per 100 full-time employees in the US and is categorized into specific industries.

The below table presents the OSHA’s “incident rate” by industry for automobile manufacturing, general warehousing and retailers between 2010 and 2012. Consistently year over year, there is a 60% greater incident rate for general warehousing compared to retailers. This trend is expected to remain the same or increase with the advent of new technologies that require human interaction with automated machinery on the warehouse floor to increase productivity and deliver improved efficiencies. The addition of machinery typically used in factories will cause the warehousing incident rate to move up towards the manufacturing incident rate if precautions are not taken to protect the workforce.

 OSHA's Workplace Incidents 2010-2012

The good news is there are options for companies in both the manufacturing and warehousing industries to ensure the safety and health of employees.  The options include the application of mandatory and voluntary national safety and health standards in the workplace. The standards cover the range of safety hazards from process to equipment and outline how to mitigate safety hazards through well-prepared procedures, training, periodic inspection and machinery assessments. 

TÜV Rheinland’s safety solutions bring qualified engineers, industrial hygienists, and occupational safety experts to the doors of your facility to ensure your warehouse or production facilities operations and equipment meet OSHA, other State OSHA plans , CAL/OSHA, and ANSI/NFPA standards. Our services include training staff and facility inspections, Risk Assessment, equipment certification, arc flash studies, equipment listing and field evaluation services. Typical standards used in our assessments include NFPA 70E, OSHA CFR 1910, ANSI A10, Z400, A1264, RIA 15.06-2. 

Contact TÜV Rheinland (1-888-743-4652) today for a free consultation on your current needs and to learn how TÜV Rheinland can partner with your company to reduce the safety hazards in your workplace. You can also read more about our EHS Services.

Webinar: How REACH is Affecting the Chemical Industry

  
  
  

describe the imageThe most comprehensive European chemical regulation, REACH, is affecting global chemical suppliers and products. Learn how this regulation affects the manufacture and import of chemicals and related products to Europe.

In collaboration with the Department of Commerce, TÜV Rheinland's REACH expert Scott Sagamang will be presenting a webinar on June 24, 2014 at 11:00am EDT.

 

 

Event Details

  • If you are an EU exporter of chemicals or chemical mixtures at annual volumes of over 2,200 lbs., learn what is required after “pre-registration”.
  • Learn how to determine if your product is an article or a preparation within the REACH regulation.
  • Learn about the registration process, supply chain roles, SIEF, Consortia participation, MSDS, dossier requirements, SVHC and the Only Representative Role.
  • Ask questions of the presenters and listen to the answers provided to other participants.

What Industries Does REACH Regulation Affect?

  • Chemical Industry
  • Petroleum Processing
  • Plastics Processing
  • Optics
  • Engine/Plant Production
  • Fine Mechanics
  • Recycling
  • Cosmetics
  • Food
  • Furniture
  • Sports Equipment
  • Toys
  • Leather and Drapery
  • Printing

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