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EVS-EN 60601-1-4:2000

Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral Standard: Programmable electronical medical systems

General information
Withdrawn from 02.08.2012
Base Documents
IEC 60601-1-4:1996; EN 60601-1-4:1996
ICS Groups
11.040.01 Medical equipment in general 35.240.80 IT applications in health care technology
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Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard.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/

Standard history

Status
Date
Type
Name
08.12.2006
Main + corrigendum
EVS-EN 60601-1:2006
Main
EVS-EN 60601-1-4:2000
Amendment
EVS-EN 60601-1-4:2000/A1:2002
This Collateral Standard applies to the safety of medical electrical equipment and medical electrical systems incorporating programmable electronic subsystems (PESS), hereinafter referred to as programmable electrical medical systems (PEMS).
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Standard monitoring
English Estonian

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Amendment

EVS-EN 60601-1-4:2000/A1:2002

Medical electrical equipment - Part 1-4: General requirements for safety. 4. Collateral Standard: Programmable electronical medical systems
Withdrawn from 02.08.2012
Main + corrigendum

EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
Valid from 08.12.2006
Main

EVS-EN ISO 14971:2019

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Valid from 02.01.2020
Main

EVS-EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021

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Amendment

EVS-EN 60601-1-4:2000/A1:2002

Medical electrical equipment - Part 1-4: General requirements for safety. 4. Collateral Standard: Programmable electronical medical systems
Withdrawn from 02.08.2012
Main

EVS-EN 60601-1-8:2007

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Valid from 05.12.2007
Main + corrigendum

EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
Valid from 08.12.2006
Main

EVS-EN 60601-1-1:2002

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
Withdrawn from 02.08.2012

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

standard@evs.ee
+372 605 5060
Akadeemia tee 21/6, Tallinn, 12618, Estonia
Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
E-N 8:30-17:00 R 8:30-16:00

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