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EVS-EN 60601-2-45:2011

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

General information

Valid from 05.04.2011
Base Documents
IEC 60601-2-45:2011; EN 60601-2-45:2011
ICS Groups
11.040.50 Radiographic equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
Amendment
EVS-EN 60601-2-45:2011/prA2
Main + amendment
prEVS-EN 60601-2-45:2011+A1:2015+A2
02.08.2017
Main + amendment
EVS-EN 60601-2-45:2011+A1:2015
06.10.2015
Amendment
EVS-EN 60601-2-45:2011/A1:2015
05.04.2011
Main
EVS-EN 60601-2-45:2011
Main
EVS-EN 60601-2-45:2002
This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT.

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English (PDF 362 KB)

Related products

Main + amendment

EVS-EN 60601-2-45:2011+A1:2015

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Newest version Valid from 02.08.2017
Amendment

EVS-EN 60601-2-45:2011/A1:2015

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Valid from 06.10.2015
Main

EVS-EN 60601-2-25:2015

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Newest version Valid from 04.11.2015
Main

EVS-EN 60601-2-27:2014

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Newest version Valid from 03.09.2014

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Amendment

EVS-EN 60601-2-45:2011/A1:2015

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Valid from 06.10.2015
Main

EVS-EN 60601-2-47:2003

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
Withdrawn from 08.06.2015
Main

EVS-EN 60601-2-5:2002

Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
Withdrawn from 04.11.2015
Main

EVS-EN 60601-2-50:2009

Medical electrical equipment -- Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment
Withdrawn from 03.08.2021

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