TÜV Product Service extends medical device testing service in UK
27 October 2009
TÜV Product Service, the world’s largest medical device
notified body, is extending its UK-based active medical device testing
The TÜV Active Medical Device Service includes safety testing for the
first time and is responding to a surge in demand from UK customers that
are preparing for the 2012 third Edition of the Medical Electrical
Equipment Standard (IEC 60601-1:2005).
The new service will complement TÜV’s existing EMC and environmental
testing performed at its UK laboratories and factory assessments carried
out by its UK audit team. The company has sites in Fareham, Hampshire
and Walton on Thames, Surrey.
The TÜV service has been designed to give UK manufacturers complete
flexibility in how their products are tested. Manufacturers can
therefore choose to use either an off-site service, where testing is
conducted at TÜV’s laboratories, or an on-site service at the customer’s
own site. This flexible approach will to help decrease time to market
for products, while ensuring compliance and safety.
Jean-Louis Evans, Managing Director of TÜV Product Service said: “The
manufacture and sale of medical devices is becoming increasingly
difficult for our customers to navigate alone. The market is very
competitive and constantly evolving with the introduction of new
standards and legislation, both in the EU and globally. It is therefore
proving essential for us to offer a service that is on-the-ground in the
UK, to give our customers greater choice and a faster turnaround.
“As the deadline for 2012’s new Medical Electrical Equipment Standard
looms, we are finding that many of our customers are concerned that test
houses will be booked solid as the cut-off date approaches. We hope the
new service will assuage those concerns and deliver a robust alternative
to manufacturers in the active medical device sector,” concluded Evans.
The Active Medical Device Service will cover any medical equipment
which depends on an electrical source or any source of power, other than
that directly generated by the human body or gravity.
The new TÜV Active Medical Device Service will include:
- Conformity assessment against the relevant Medical Devices,
Active Implantable Medical Devices or In Vitro Diagnostic Medical
- Performing of laboratory tests (electrical safety, mechanical
safety, performance tests etc.) according to IEC 60601-1, IEC
60601-1-1 and selected part two standards.
- Assessment of safety-related issues and of solution models
- Assessment of the functional safety of active medical devices
(safety of hardware and software).
- Assessment of the usability of active medical devices.