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IEC TR 62354

General testing procedures for medical electrical equipment

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Organization: IEC
Publication Date: 1 September 2014
Status: active
Page Count: 218
ICS Code (Medical equipment): 11.040
scope:

This technical report applies to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63 of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988), hereinafter referred to as ME EQUIPMENT.

The object of this technical report is to provide guidance on general testing PROCEDURES according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

Document History

IEC TR 62354
September 1, 2014
General testing procedures for medical electrical equipment
This technical report applies to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63 of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988), hereinafter referred to as ME EQUIPMENT. The object...
IEC/TR 62354
October 1, 2009
General testing procedures for medical electrical equipment
Scope and object This technical report applies to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63 of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988), hereinafter referred to as ME...
IEC/TR 62354
December 1, 2005
General testing procedures for medical electrical equipment
A description is not available for this item.

References

This document references:
ASTM D149 - Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
Published by ASTM on January 1, 2020
This test method covers procedures for the determination of dielectric strength of solid insulating materials at commercial power frequencies, under specified conditions.2,3 Unless otherwise...
This document references:
IEC 60065 - Audio, video and similar electronic apparatus – Safety requirements
Published by IEC on June 1, 2014
A description is not available for this item.
This document references:
IEC 60086-4 - Primary batteries – Part 4: Safety of lithium batteries
Published by IEC on April 1, 2019
This part of IEC 60086 specifies tests and requirements for primary lithium batteries to ensure their safe operation under intended use and reasonably foreseeable misuse. NOTE Primary lithium...
This document references:
IEC 60127-1 - Miniature fuses – Part 1: Definitions for miniature fuses and general requirements for miniature fuse-links
Published by IEC on February 1, 2015
This part of IEC 60127 covers the general requirements and tests applicable to all types of miniature fuse-links (e.g. cartridge fuse-links, sub-miniature fuse-links and universal modular fuse-links)...
This document references:
IEC 60252-1 - AC motor capacitors – Part 1: General – Performance, testing and rating – Safety requirements – Guidance for installation and operation
Published by IEC on August 1, 2013
Scope and object This part of IEC 60252 applies to motor capacitors intended for connection to windings of asynchronous motors supplied from a single-phase system having a frequency up to and...
This document is referenced by:
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 t o as ME EQUIPMENT and ME...
This document is referenced by:
SNZ AS/NZS IEC 60601.1 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Published by SNZ on September 23, 2015
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:
IEC 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
This document is referenced by:
CSA C22.2 NO 80601-2-55 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Published by CSA on January 1, 2014
This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for...
This document is referenced by:
EN 60601-2-40 - Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Published by CENELEC on January 1, 2019
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. NOTE Myofeedback equipment,...
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