Back

EVS-EN 60601-1-8:2007+A1+A11+A2:2021

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 (IEC 60601-1-8:2006 + IEC 60601-1-8:2006/A1:2012 + IEC 60601-1-8:2006/A2:2020)

General information

Valid from 17.08.2021
Base Documents
IEC 60601-1-8:2006; EN 60601-1-8:2007; EN 60601-1-8:2007/AC:2010; IEC 60601-1-8:2006/A1:2012; EN 60601-1-8:2007/A1:2013; EN 60601-1-8:2007/A1:2013/AC:2014; EN 60601-1-8:2007/A11:2017; IEC 60601-1-8:2006/A2:2020; EN 60601-1-8:2007/A2:2021
ICS Groups
11.040.01 Medical equipment in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
17.08.2021
Main + amendment
EVS-EN 60601-1-8:2007+A1+A11+A2:2021
03.08.2021
Amendment
EVS-EN 60601-1-8:2007/A2:2021
03.02.2020
Main + amendment
EVS-EN 60601-1-8:2007+A1+A11:2017
04.04.2017
Amendment
EVS-EN 60601-1-8:2007/A11:2017
05.06.2014
Corrigendum
EVS-EN 60601-1-8:2007/A1:2013/AC:2014
06.05.2013
Amendment
EVS-EN 60601-1-8:2007/A1:2013
08.04.2010
Corrigendum
EVS-EN 60601-1-8:2007/AC:2010
05.12.2007
Main
EVS-EN 60601-1-8:2007
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.
It also provides guidance for the application of ALARM SYSTEMS.

Required fields are indicated with *

*
*
*
PDF
39.04 € incl tax
Paper
39.04 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 2 MB)

Related products

Main + amendment

EVS-EN ISO 13485:2016+A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 16.09.2021
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
Main

CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Newest version Valid from 03.08.2020
Main

EVS-EN ISO 14971:2019

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

Customers who bought this item also bought

Main + amendment

EVS-EN 60601-1-6:2010+A1+A2:2021

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + IEC 60601-1-6:2010/A1:2013 + IEC 60601-1-6:2010/A2:2020)
Newest version Valid from 17.08.2021
Main + amendment

EVS-EN 60601-1-2:2015+A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + IEC 60601-1-2:2014/A1:2020)
Newest version Valid from 01.04.2021
Main + amendment

EVS-EN 60601-1:2006+A1+A12+A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, modified + A1:2013 + A12:2014 + IEC 60601-1:2005/A2:2020)
Valid from 01.11.2021
Main + amendment

EVS-EN 60601-1-11:2015+A1:2021

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 + IEC 60601-1-11:2015/A1:2020)
Newest version Valid from 17.08.2021

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