Diesse MINI-CUBE - Page 5

M I N I - C U B E – U S E R M A N U A L
5/59 Rev 1.3 06/2018
Standards applied to this document:
- Directive 98/79/EC on in vitro diagnostic medical devices
- EN 61010-1 (CEI 66-5) “Safety requirements for electrical equipment for measurement,
control laboratory use – Part 1: General requirements”.
- EN 61326-1 “Electrical Equipment for Measurement, Control, and Laboratory Use –
Electromagnetic compatibility requirements – Part 1: General requirements”
- EN 61326-2-6 “Electrical Equipment for Measurement, Control, and Laboratory Use –
Electromagnetic compatibility requirements - Part 2 – 6: In Vitro Diagnostic (IVD) medical
equipment”
- EN 61010-2-081 Safety for electrical equipment for measurement, control, laboratory use
– Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes (CEI 66-8)”.
- EN 61010-2-101 “Safety for electrical equipment for measurement, control, laboratory
use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment”.
- 2014/35/EC “Low voltage directive”
- 2014/30/EC “Directive on the harmonisation of the laws of the Member States relating to
electromagnetic compatibility”
- 2011/65/EU “Directive on the restriction of the use of certain hazardous substances in
electrical and electronic equipment – RoHS2”
- UNI EN ISO 18113-3 Information provided by the manufacturer (labeling) - Part 3: in vitro
diagnostic instruments for professional use
- UNI EN ISO 22870 Point of care testing (IOCT) – Requirements for quality and
competence
- Clinical and Laboratory Standards Institute, H02-A5, Procedures for the Erythrocyte
Sedimentation Rate Test; Approved Standard—Fifth Edition
The information contained in this manual may be subject to modifications without prior notice. No page
in this manual may be reproduced in any form or by any means, electronic, mechanical or otherwise,
for any use whatsoever without prior written permission from DIESSE DIAGNOSTICA SENESE S.p.A.