Diesse MINI-CUBE - Page 5

Rev. 1.2 (12.2021) MINI-CUBE | SERVICE MANUAL 5
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, Procedures for the Erythrocyte
Sedimentation Rate Test; Approved Standard—Fifth Edition