Back

IEC 60601-1-8:2006+AMD1:2012 CSV

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

General information

Valid from 28.11.2012
ICS Groups
11.040.01 Medical equipment in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
28.11.2012
Main
IEC 60601-1-8:2006+AMD1:2012 CSV
IEC 60601-1-8:2006+A1:2012 Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.

This consolidated version consists of the second edition (2006)  
and its amendment 1 (2012). Therefore, no need to order amendment in
addition to this publication.                                  

Required fields are indicated with *

*
*
*
PDF
904.68 € incl tax
Standard monitoring
English (PDF 945 KB)

Related products

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
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

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

Customers who bought this item also bought

Main

EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 07.05.2015
Main

EVS-EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Valid from 03.12.2015
Main + amendment

EVS-EN 60601-1:2006+A1:2013+A12:2014

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Valid from 02.03.2016
Main

ISO 9022-22:2012

Optics and photonics -- Environmental test methods -- Part 22: Combined cold, dry heat or temperature change with bump or random vibration
Newest version Valid from 16.04.2012

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