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EVS-EN 60601-2-18:2001

Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment

General information

Withdrawn from 04.11.2015
Base Documents
IEC 601-2-18:1996; EN 60601-2-18:1996
ICS Groups
11.040.50 Radiographic equipment
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard.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/

Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
04.11.2015
Main
EVS-EN 60601-2-18:2015
01.01.2003
Amendment
EVS-EN 60601-2-18:2001/A1:2002
01.05.2001
Main
EVS-EN 60601-2-18:2001
This particular standard specifies requirements for the safety of endoscopic equipment and integrated instrumentation used for medical diagnosis and therapy and for treatment in body cavities. It is subdivided
into five applications concerning endoscopes for (a) direct visualiztion, (b) integration with thermocautery or (c) lithotrite, (d) electrosurgery and (e) other specialized endoscopes.

Required fields are indicated with *

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Standard monitoring
English (PDF 730 KB)

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Main

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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