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CEI EN 60601-1-8

Medical electrical equipment Part 1: 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

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Organization: CEI
Publication Date: 1 March 2014
Status: inactive
Page Count: 34
ICS Code (Medical equipment in general): 11.040.01
scope:

INTRODUCTION TO THE AMENDMENT

The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue has been identified with respect to pulse and burst testing. In addition, issues have been raised by IEC/62D/MT 22, Electromedical diagnostic and patient monitoring equipment, during implementation of alarm system requirements in particular standards within their scope of work.

At the Brussels meeting, IEC/SC 62A accepted a proposal, based on ISO/TC 121/SC 3 Resolution Orebro 6, to develop the 1st amendment to IEC 60601-1-8:2006 to address the issues identified above. IEC/SC 62A - ISO/TC 121/SC 3 Joint Working Group 2, Alarms, was reactivated as a maintenance team to develop this amendment.

Document History

CEI EN 60601-1-8
January 1, 2018
Medical electrical equipment Part 1: 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
A description is not available for this item.
CEI EN 60601-1-8
October 1, 2017
Medical electrical equipment Part 1: 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
A description is not available for this item.
CEI EN 60601-1-8
August 1, 2014
Medical electrical equipment Part 1: 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
INTRODUCTION TO THE AMENDMENT The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue has been identified with respect to pulse and burst testing. In addition,...
CEI EN 60601-1-8
March 1, 2014
Medical electrical equipment Part 1: 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
INTRODUCTION TO THE AMENDMENT The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue has been identified with respect to pulse and burst testing. In addition,...
CEI EN 60601-1-8
May 1, 2010
Apparecchi elettromedicali - Parte 1: Prescrizioni generali di sicurezza - Norma collaterale: Sistemi di allarme - Prescrizioni generali, prove e linee-guida per sistemi di allarme usati in apparecchi e sistemi elettromedicali
La presente Variante recepisce il corrigendum EN 60601-1-8/EC:2010-03 che introduce una DOW al 2012-06-01 e cancella le frasi che non sono più valide.
CEI EN 60601-1-8
November 1, 2009
Medical electrical equipment Part 1: 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
La Norma si riferisce alla sicurezza elettrica e alle prestazioni essenziali relative ai sistemi di allarme negli apparecchi e sistemi elettromedicali e fornisce una guida al corretto utilizzo di...
EN 60601-1-8
November 1, 2007
Medical electrical equipment - Part 1: 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
La Norma si riferisce alla sicurezza elettrica e alle prestazioni essenziali relative ai sistemi di allarme negli apparecchi e sistemi elettromedicali e fornisce una guida al corretto utilizzo di...
EN 60601-1-8
July 1, 2007
Apparecchi elettromedicali - Parte 1: Prescrizioni generali di sicurezza - Norma collaterale: Sistemi di allarme - Prescrizioni generali, prove e linee-guida per sistemi di allarme usati in apparecchi e sistemi elettromedicali - VERSIONE ITALIANO-INGLESE CONSOLIDATA. VEDERE SOMMARIO
Il presente fascicolo risulta un'edizione consolidata del testo delle Norme Europee EN 60601-1-8:2004 e EN 60601-1-8/A1:2006. Rispetto ai precedenti (fasc. 7820E e 8411E), esso comprende la versione...
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References

This document references:
7000 DATABASE SNAPSHOT - Graphical symbols for use on equipment - Registered symbols
Published by ISO on June 3, 2020
A description is not available for this item.
This document references:
CEI EN 61672-1 - Electroacoustics - Sound level meters Part 1: Specifications
Published by CEI on July 1, 2014
This part of IEC 61672 gives electroacoustical performance specifications for three kinds of sound measuring instruments: a time-weighting sound level meter that measures exponential-time-weighted,...
This document references:
CEI EN 62366 - Medical devices - Application of usability engineering to medical devices
Published by CEI on October 1, 2008
La presente Norma specifica il processo che un costruttore deve seguire per analizzare, specificare, progettare, verificare e validare le caratteristiche utilizzative, in relazione alla sicurezza di...
This document references:
EN ISO 3744 - Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane
Published by CEN on October 1, 2010
General This International Standard specifies methods for determining the sound power level or sound energy level of a noise source from sound pressure levels measured on a surface enveloping the...
This document references:
EN 60601-1 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Published by CENELEC on October 1, 2006
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 document references:
IEC 61672-1 - Electroacoustics - Sound level meters - Part 1: Specifications
Published by IEC on September 1, 2013
This part of IEC 61672 gives electroacoustical performance specifications for three kinds of sound measuring instruments: a time-weighting sound level meter that measures exponential-time-weighted,...
This document references:
ISO 3744 - Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane
Published by ISO on October 1, 2010
General This International Standard specifies a method for measuring the sound pressure levels on a measurement surface enveloping a noise source, under essentially free-field conditions near one or...
View Less
View All
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