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Product Testing and Certification

IEC 61326-2-6: In vitro diagnostic (IVD) medical equipment – EMC requirements

The new edition of the standard that covers EMC testing of in-vitro (IVD) medical equipment – IEC 61326-2-6:2020 has been published recently. The latest version of IEC 61326-2-6 completely rewrites the EMC approach to IVD devices ...

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A new standard for equipment operating in 2.4 GHz band (WiFi, Bluetooth)

The transition period for the harmonized standard EN 300 328, which covers equipment operating in the 2.4 GHz band (WiFi, Bluetooth), has ended. The previous version (V2.1.1) of the standard was withdrawn on 6 August 2021 and the devices covered b...

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Harmonisation of EN IEC 62368-1:2020

The Secretariat of CLC/TC 108X sent out an enquiry to National Committees to check and verify the acceptance of Amendment prEN IEC 62368-1:2019/prAB prepared by WG6 before its possible submission to the Enquiry. The outcome was to recommend sus...

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Postponed requirement for mandatory UKCA marking

The UK Government has recently confirmed that the mandatory UKCA marking is postponed until 1 January 2023. Thereby, businesses will have an extra year to start using the UKCA conformity marking, i.e., the UK ‘version’ of the Euro...

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New requirements for the registration of EAC Declarations of Conformity in Russia announced

As of 1 January 2021, new rules for the registration of EAC declarations apply. According to the decree of the Ministry of Economic Development of the Russian Federation, the submission of a Global Location Number (GLN for short) ...

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