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EVS-EN 61010-2-101:2003

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

General information
Withdrawn from 02.03.2017
Base Documents
IEC 61010-2-101:2002; EN 61010-2-101:2002
ICS Groups
11.040.55 Diagnostic equipment 19.080 Electrical and electronic testing
Directives or regulations
98/79/EC In vitro diagnostic medical devices

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 98/79/EC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
02.03.2017
Main
EVS-EN 61010-2-101:2017
01.04.2003
Main
EVS-EN 61010-2-101:2003
Applies to equipment intended for in vitro diagnostic (IVD) medical purposes. This is used for the examination of specimens, including blood and tissue samples, derived from the human body. The standard also covers self-test IVD medical equipment for use by lay persons.
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Standard monitoring
English

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English

Contact

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Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
E-N 8:30-17:00 R 8:30-16:00

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