New standards

News in the area of guidelines and standards

Last update: Q3 2024

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Red: No longer valid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

Identification	Description	Status	Version	Date of issue	Remarks	Additions to standard
EN 12184	Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods	P	Fourth edition	2014-03-01	--
EN 12184	Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods	P	Fifth edition	2022-09-01	Supersedes EN 12184:2014
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	H , P	Edition 1	2006-05-01	Standard is harmonized under the In vitro diagnostic medical devices directive 98/79/EC.	EN 61326-2-6/C1
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 2	2013-05-01	Supersedes EN 61326-2-6:2006. Standard is not yet harmonized.
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.
EN-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	P	Edition 4.0	2015-09-01	--	EN 60601-1-2/A1
European standards	Updated list of harmonised standards for Medical devices	TR	NA-	2017-11-17	--	Decision 2021/1182 Decision 2022/6 Decision 2022/757 Decision 2023/1410 Decision 2024/815
FDA Guidance	Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff	TR	NA-	2022-06-06	--
IEC TR 60601-4-2	Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems	TR	Edition 1.0	2016-05-01	--
IEC TS 60601-4-2	Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems	TR	Edition 1.0	2024-03-01	Supersedes IEC TR 60601-4-2:2016
ISO 7176-21	Wheelchairs — Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers	P	Second edition	2009-04-01	--
Regulation 2017/745	Medical Devices Regulation	R	NA-	2017-05-26	--