New standards

News in the area of guidelines and standards

Last update: Q3 2023

Standardization is an ongoing process, trying to keep up with the 'state of art' of technology. As a result, standards are being updated and replaced in an increasing rate. Keeping up to date is a laborious task. Kiwa Dare monitors the changes and report them on this page for you. In this regular column, we'll try to keep you as much as possible up to date of changes and expected modifications.

Important Notices:

These pages contain the most commonly used standards and guidelines by Kiwa Dare. Standards not included in this overview can be applied on request. A complete overview of harmonized standards is included in the overview (if applicable).

bekijk de tabel Medical Devices Regulation

Electromagnetic Compatibility (EMC)

Medical Devices Regulation

Legenda:

In the column 'Status' the following codes are used:

A: Amendment
B: Basic standard
C: Correction
G: Generic standard
H: Harmonised standard
P: Product standard
D: Directive
R: Regulation
TR: Technical Reference
M: Manufacturer specific requirements

The validity of the standards/directives etc. is color coded:

Green: Valid
Orange: Will be changed or replaced soon
Red: No longer valid
Blue: Transition period
Yellow: Can be used as technical reference document

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Identification	Description	Status	Version	Date of issue	Remarks
EN 61326-2-6	Electrical equipment for measurement, control and laboratory use – EMC requirements Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment	P	Edition 3	2021-06-01	Supersedes EN 61326-2-6:2013 and all of its amendments and corrigenda (if any). Standard is not yet harmonized.