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CENELEC - 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: CENELEC
Publication Date: 1 June 2021
Status: active
Page Count: 22
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

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...
EN 61326-2-6
May 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...
EN 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
A description is not available for this item.

References

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:
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:
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:
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:
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:
BS EN ISO 15197 - TC - Tracked Changes (Redline) - In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
Published by BSI on February 25, 2020
A description is not available for this item.
This document is referenced by:
EN IEC 61010-2-101 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
Published by CENELEC on January 1, 2022
Scope and object General This part of IEC 61010 provides particular safety requirements to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes....
This document is referenced by:
PREN 50549-10 - Requirements for generating plants to be connected in parallel with distribution networks - Part 10: Tests for conformity assessment of generating units
Published by CENELEC on March 1, 2022
The purpose of this document is to provide technical guidance for tests on generating units and interface protection to evaluate their electrical characteristics. NOTE 1 Mechanical issues are taken...
This document is referenced by:
BS EN ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by BSI on June 30, 2015
A description is not available for this item.
This document is referenced by:
NEN-EN 50549-10 - Requirements for generating plants to be connected in parallel with distribution networks - Part 10: Tests for conformity assessment of generating units
Published by NEN on November 1, 2022
The purpose of this document is to provide technical guidance for tests on generating units and interface protection to evaluate their electrical characteristics. NOTE 1 Mechanical issues are taken...
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