Tissue Engineering and Risk Management

Munich. The “Tissue Engineering and Risk Management” project is the winner of the 2013 DIN Prize for Innovation. In this project, an international group of experts developed the ISO 13022 standard governing risk management for medical products containing human cells. The award was accepted by Prof. Dr. Dr. Sabine Kloth from TÜV SÜD Product Service GmbH, who has been in charge of the project since 2007. The cash prize of EUR 3,000 accompanying the award was donated to the Munich charity lichtblick hasenbergl.

Recent years have seen an array of innovations in the field of surgical implants based on tissue engineering. However, the market launch of these products has been severely hampered by the extensive differences in regional regulatory systems. “Our aim in developing the ISO 13022 standard was to streamline the evaluation criteria for the approval of these implants and thus to improve safety for both patients and medical staff”, explains Prof. Dr. Dr. Sabine Kloth, Senior Product Specialist at TÜV SÜD Product Service GmbH. The standard was developed from 2008 by a board of international experts headed by Prof. Kloth.

The ISO 13022 standard supports innovative methods of regeneration to replace diseased and destroyed tissue by implanting products based on human cells. The standard covers a range of products which differ widely from a regulatory perspective. A further special feature is that the risk assessment for cell-based products is placed within the context of benefits for the patient. “Risk/benefit assessment is the focus of the standard”, stresses Prof. Kloth. At present only a very small number of documents worldwide address this connection.

The development of the ISO 13022 international standard has now created a standardised global instrument which supports product approval throughout a variety of economic regions. The group of experts is now working on further projects concerning standards for production and storage of materials, requirements for bioreactors, matrices for biologised heart valves and quality control testing systems.

The German Ministry of Education and Research is supporting these projects, awarding a cooperation project to DIN and TÜV SÜD aimed at improving standardisation work in university environments, start-ups and SMEs.

More information on Medical and Health Services from TÜV SÜD Product Service is available at www.tuev-sued.de/mhs.

TÜV SÜD: Michael Valente appointed CEO Western Europe

The international technical services company TÜV SÜD recently appointed Michael Valente new CEO of the Western Europe region: With effect from the beginning of April 2013, the 55 year old manager has taken over responsibility for the third largest region in the TÜV SÜD Group: in 2012, the Western Europe region generated revenue of almost EUR 200 million – a year-on-year growth of some 30 per cent, not least due to numerous company acquisitions. The company plans to further expand its presence in this region over the next years.

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TÜV SÜD: The face of classic car expertise – Matthias Gerst

The original engine in a Buick Electra? Modern rims on a Mercedes 'Pagoda'? TÜV SÜD's classic car expert Matthias Gerst can answer questions like these without even thinking. Gerst has been collecting vehicle data for over 40 years; the unique body of information collected in his pioneering work has formed the basis for over 50,000 data sheets. Gerst's dedication will be honoured on 1 June when the 57-year-old native of Stuttgart, Germany, receives the RetroClassicCultur Award at the tenth RetroClassics Meets Barock event. TÜV SÜD is the safety partner for this meet-up of classic car enthusiasts.

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Violation of REACH regulation can result in severe fines

Violations of the European chemicals regulation REACH will be subject to more severe penalties in the future. TÜV SÜD references the relevant provisions in the European regulation concerning violation of the chemicals legislation that recently came into force in Germany. In a worst case scenario, violations may be punished by up to two years in prison or a fine of up to EUR 50,000.

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The Internet – a scammers' haven

The Internet makes life easier in many respects. Shopping from the comfort of your sofa, making travel arrangements, looking for information or making new contacts – almost anything is possible.However, the Internet is also a scammers' haven.Given this, caution is the watchword for all online shoppers and other Web surfers.TÜV SÜD's expert Rainer Seidlitz gives tips on how to avoid unpleasant surprises.

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Safe journey into the best weeks of the year

Cars are the most popular method of transport for holidaymakers. But a careful check of the vehicle's condition and equipment is vital to ensure the journey to and from the holiday destination is free from unwelcome incidents. Here are TÜV SÜD's tips for a safe trip.

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TÜV SÜD certificate for the world's first Green Amusement Park

The "Green Amusement Park" certificate from TÜV SÜD Industrie Service is a landmark standard for assessing and confirming the sustainability and environmental compatibility of amusement parks.Europa-Park, Germany´s largest theme park located in Rust, Baden-Wuerttemberg, has now been certified as the first green amusement park worldwide.Certification focuses on areas such as building services and amusement ride systems, construction, land use, transport planning and the handling of waste-water and existing contamination.

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