TRaC Awarded IECEE Accreditation for In Vitro Diagnostic Medical Equipment

TRaC, a global leader in testing and certification services has announced that it has successfully expanded its IECEE CB Scheme Testing Laboratory (CBTL) capabilities. The new capabilities include product safety and conformity assessment testing and certification of In Vitro Diagnostic (IVD) type products.

The new accreditation allows TRaC to test and issue IECEE CB Scheme Test Certificates to conduct IEC 61010-2-101 (Particular requirements for IVD medical equipment) and IEC 61010-2-081 (Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes). These standards are heavily used within the IVD equipment arena and have some particular requirements for risk management and risk assessment as called up by ISO 14971.

TRaC will provide manufacturers with market access to more than 40 countries that participate in the IECEE's CB Scheme, reducing their time-to-market.

TRaC Offers Safety Test Service for In Vitro Diagnostic Medical Systems

TRaC, the leading test house, now has full accreditation at its UK facilities to carry out safety testing of all medical diagnostic products that fall within the scope of the In Vitro Diagnostic (IVD) Medical Devices Directive.

In Vitro Devices are items of diagnostic equipment that carry out medical tests on samples (for example, blood) obtained from the human body, but that do not operate directly in contact with the body.  The IVD Directive lays down a specific set of requirements for such equipment (distinct from diagnostic equipment such as monitors that are connected to the patient and have their own regulatory framework) in terms of their safety, quality and performance.

The IVD Directive sets out four classifications of product: General; Self-Test (i.e. products that patients may use themselves without medical supervision); and two higher categories of Test Kits and Devices that

Why does volcanic ash cause aircraft flights to be cancelled?

The news is full of stories about the significant disruption to air traffic in Northern Europe due to the volcanic eruption in the south west part of Iceland's Eyjafjallajoekull glacier.

Aircraft are not permitted to fly into volcanic ash clouds because there is a risk of damage to aircraft components and systems by:

• Abrading forward facing surfaces including cockpit windows, control surfaces, wing leading edges. Cockpit windows can be pitted enough to cause significant hazards during landing.
• Causing engine failure due to accumulations forming on the turbine blades caused by fusing of the silica particles at around 1100 OC.
• Coating the plane enough to cause it to become tail heavy.
• Penetrating the aircraft, contaminating the passenger compartment and affecting the aircraft's internal systems.

HALT / HASS Seminar - Thursday 13th May 2010

To guide you in your product development, TRaC are hosting a Technology Insight Briefing that will both explain the concept, and provide a practical demonstration of HALT (Highly Accelerated Life Test) and HASS (Highly Accelerated Stress Screening).

Mr. Bob Page of Reliability Plus, an industry expert in this field, will lead the presentation being held at the TRaC Environmental & Analysis facility in Warwick on Thursday 13th May from 9am to 4pm. This seminar will be particularly useful to Engineers who are managing new product development programmes.

HALT is rapidly emerging as a recognised means to dramatically cut development timescales through a process of accelerated aging. This is achieved by employing high levels of multi-axial vibration and rapid temperature cycling, either separately or in combination. Whilst the test does not mimic a particular reality, it very effectively employs environmental conditions commonly experienced in

TRaC adds test house knowledge to Military CE marking guide

TRaC, international provider of equipment test, certification and validation services, is contributing its expertise to the definition of a major revision of a pan-European document that will provide guidance on the complex issue of CE marking of equipment for military applications.

TRaC has extensive experience in conformance testing, to a broad range of standards and directives, for commercial, industrial and medical equipment: and of testing military systems to the standards prevalent in that sector. The company was therefore ideally equipped to respond to a request to contribute to the new, definitive Guide to CE Marking Military Equipment. The Guide is currently at an advanced stage of preparation and a draft will be available in time for Defence Equipment and Support’s DVD 2010 event at Millbrook, Bedfordshire, UK, June 23 – 24, where

TRaC initiates test services for both ZigBee Health Care and ZigBee Telecoms Services products

TRaC has further extended its leading position in testing and certification services by adding formal certification testing to the new ZigBee Health Care Profile, within days of the Profile being ratified by the ZigBee Alliance.

Alongside the ZigBee Health Care Profile, TRaC has added certification testing for the ZigBee Telecoms Services Profile: together, these new test services mean that TRaC is now providing comprehensive certification routes for the broad range of ZigBee-based consumer devices in those areas which are expected to emerge in the coming weeks and months.

The ZigBee Telecoms Service Profile sets out a global standard for wireless sensor networks, which will supply consumer devices with information, location-based services, entertainment content, payment and billing services, and data-exchange services. It will enable consumer devices with an almost limitless