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NEN-EN-IEC 61326-2-6

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

active, Most Current
Organization: NEN
Publication Date: 1 June 2021
Status: active
Page Count: 44
ICS Code (Electromagnetic compatibility (EMC)): 33.100
ICS Code (Electricity. Magnetism. Electrical and magnetic measurements): 17.220
ICS Code (Immunity): 33.100.20
ICS Code (Industrial process measurement and control): 25.040.40
ICS Code (Measurement of electrical and magnetic quantities): 17.220.20
scope:

In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.

Document History

NEN-EN-IEC 61326-2-6
June 1, 2021
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL...
NEN-EN-IEC 61326-2-6
June 1, 2013
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
In addition to the scope of IEC 61326-1, this part of IEC 61326 series specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic...
NEN-EN-IEC 61326-2-6/C1
October 1, 2007
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
A description is not available for this item.
NEN-EN-IEC 61326-2-6
May 1, 2006
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
In addition to the scope of International Standard IEC 61326-1, this part specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic...

References

This document references:
AAMI TIR18 - Guidance on electromagnetic compatibility of medical devices in healthcare facilities
Published by AAMI on January 1, 2010
Introduction and scope Because the performance of electronic medical devices can be disrupted by electromagnetic (EM) energy, patient safety can potentially be put at increased risk because of the...
This document references:
IEC 61326-1 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
Published by IEC on October 1, 2020
This part of IEC 61326 specifies requirements for immunity and emissions regarding electromagnetic compatibility (EMC) for electrical equipment, operating from a supply or battery of less than 1 000...
This document references:
ANSI C63.18 - Recommended Practice for an on-Site, Ad Hoc Test Method for Estimating Electrimagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
Published by IEEE on January 1, 2014
This recommended practice is a guide to evaluating the electromagnetic immunity of medical devices to radiated radio-frequency (RF) emissions from common RF transmitters (e.g., two-way radios;...
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 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Published by ISO on December 15, 2009
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO...
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....
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