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DS DS/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Publication Date: Mar 21, 2003
SDO: DS: Dansk Standard
 DOD Adopted   ANSI Approved Approved

This part 2 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 or 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.

CONTROL EQUIPMENT
DEFINITION
DEFINITIONS
DIAGNOSTIC EQUIPMENT
ELECTRIC APPLIANCES
ELECTRICAL ENGINEERING
IN VITRO
IN-VITRO DIAGNOSTIC
LABORATORY APPARATUS
LABORATORY MEDICINE
LABORATORY WARE
MEASURING INSTRUMENTS
MEDICAL EQUIPMENT
SAFETY
SAFETY REQUIREMENTS
SPECIFICATION (APPROVAL)
TESTING
SPECIFICATIONS
LABORATORY EQUIPMENT

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