Medical e-News Round-Up - Issue 16
- New EU standards list for in vitro diagnostic medical devices
- EU conformity move
- Check out those vital signs
- TRaC first
- And finally...Medica 2012
An updated list of standards to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro diagnostic medical devices, has been published by the Commission of the European Union (EU).
According to the EU’s Directive, an in-vitro diagnostic medical device is “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”
Under the Directive’s definition, specimen receptacles are considered to be in-vitro diagnostic medical devices, while products for general laboratory use are not, unless such products are intended to be used for in vitro-diagnostic examination.
The updated list of CEN and Cenelec standards that can be used to support compliance with the Directive was published in August 2012 in the Official Journal of the European Union, and replaces all previously published standards lists for the Directive.
The Commission of the European Union (EU) latest updated list of standards can be used to demonstrate conformity with the essential requirements of its Directive 90/385/EEC, relating to active implantable medical devices.
According to the EU’s Directive, “an ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.
“An ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.” It goes on to say.
The updated list of CEN and Cenelec standards that can be used to support compliance with the Directive was published in the Official Journal of the European Union in August 2012, and replaces all previously published standards lists for the Directive. Full details at http://ec.europa.eu
Medical devices and equipment used to check for and monitor people’s vital signs - blood pressure (invasive or non-invasive methods), temperature, electro cardiogram (ECG), respiration and blood oxygen saturation (SpO2) - needs to be checked regularly to ensure they work accurately and safely and do not pose a risk to operators and patients alike. This has led to the development of high performance simulators to undertake vital signs monitoring and performance testing.
Rigel has produced a free illustrative booklet to help people understand more, covering the performance tests (also referred to as quality or functional tests) that are typically executed using calibrated simulators across a number of applications and are all part of an acceptance test, preventative maintenance cycle or repair.
UK-based test house TRaC Global claims to be the first in the country approved to certify remote medical monitoring devices for the Continua Health Alliance.
The approval also makes TRaC the only test house in the world approved to test devices by the health alliance, the ZigBee Alliance and Bluetooth Special Interest Group, which are developing the wireless technologies utilised by Continua. The test firm will now commence work on medical devices including monitors for blood pressure and heart rate, according to Continua specifications.
TRaC director, Paul Russell, claimed the deal makes his firm a ‘one stop shop by removing the need’ for separate test houses for ZigBee and Bluetooth technologies. The Continua Alliance is a global, non-profit, organisation established to boost interoperability between remote health devices, gateways and smart phones. Visit the company’s website http://www.tracglobal.com/ for more.
Don’t forget to catch Rigel at MEDICA 2012 where its range of advanced medical device performance analysers, electrical safety analysers and vital signs simulators will be on display.
Visit us on stand C12, hall 11 to find out more about the MULTI-FLO infusion pump analyser, the UNI-THERM high current electrosurgical analyser and UNI-PULSE and meet the Rigel team led by associate director John Backes, who said:
“I’m sure the many features and benefits of the UNI-PULSE, UNI-THERM and MULTI-FLO alongside our other products will be of significant interest at MEDICA to both existing and potential new users.”