Bezpečnostní požadavky na elektrická měřicí, řídicí a laboratorní zařízení - Část 2-101: Bezpečnostní požadavky na zdravotnická zařízení pro diagnostiku in vitro (IVD) (Norma k přímému použití jako ČSN).

The information about the standard:

Designation standards: ČSN EN IEC 61010-2-101-ed.3
Classification mark: 356502
Catalog number: 516802
Publication date standards: 1.4.2023
The number of pages: 24
Approximate weight : 72 g (0.16 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN

Annotation of standard text ČSN EN IEC 61010-2-101-ed.3 (356502):

This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following: - a physiological or pathological state; or - a congenital abnormality; - the determination of safety and compatibility with potential recipients; - the monitoring of therapeutic measures. Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a home environment