Accu-Chek Aviva Nano.
This product fulfi lls the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.
This is the link to the EC Directive.
http://www.mhra.gov.uk/Howweregulate/De ... /index.htm
Take it from me it is not easy reading. Page after page after page !
Here is an extract relating to meters etc which shows that any CE marked devices are manufactured to the same standards to be EC Approved.
COMMON TECHNICAL SPECIFICATIONS
For products currently in List A of Annex II conformity assessment may involve the use of “Common Technical Specifications” (CTS) (Commission Decision of 7 May 2002 on common technical specifications for in-vitro diagnostic medical devices (notified under document C (2002) 1344) to establish performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials. CTS are drawn up by an Expert Group convened by the Commission rather than by the Standards Bodies. Manufacturers are expected to comply with the CTS. If they have justified reasons for not doing so they must adopt solutions that they can prove are at least equivalent to the CTS in terms of the above criteria.
As with harmonised standards, Member States must presume compliance with the essential requirements in respect of devices designed and manufactured in conformity with common technical specifications.
Are the Accu-Chek Aviva Nano systems approved for use in clinical settings?
Yes. The Accu-Chek Aviva Nano systems are cleared to test capillary, venous, arterial, and neonatal blood samples.
So they use them in Hospitals and they are all built to the same standards and specific tolerances.
Ken.