UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

IEC 60601-1-8

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

inactive
Buy Now
Organization: IEC
Publication Date: 1 October 2006
Status: inactive
Page Count: 162
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

IEC 60601-1-8
July 1, 2020
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
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....
IEC 60601-1-8
July 1, 2020
AMENDMENT 2 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
A description is not available for this item.
IEC 60601-1-8
November 1, 2012
AMENDMENT 1 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
A description is not available for this item.
IEC 60601-1-8
November 1, 2012
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
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....
IEC 60601-1-8
October 1, 2006
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
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...
IEC 60601-1-8
August 1, 2003
Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. It also provides guidance for the application of...
IEC 60601-1-8
August 1, 2003
Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. It also provides guidance for the application of...
View Less
View All

References

This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
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:
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...
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:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 11428 - Ergonomics - Visual Danger Signals - General Requirements, Design and Testing
Published by ISO on December 15, 1996
This International Standard describes criteria for the perception of visual danger signals in the area in which people are intended to perceive and to react to such a signal. It specifies the safety...
This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
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 is referenced by:
EN 60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Published by CENELEC on April 1, 2010
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
This document is referenced by:
IEC/TR 62296 - Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
Published by IEC on January 1, 2009
This technical report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC...
This document is referenced by:
IEC 60601-2-37 - Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Published by IEC on June 1, 2015
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or...
This document is referenced by:
EN 62304 - Medical device software - Software life-cycle processes
Published by CENELEC on July 1, 2006
Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for...
View Less
View All
Advertisement