The Inter­na­tion­al Elec­trotech­ni­cal Com­mis­sion (IEC) plans to issue the new cyber­se­cu­ri­ty stan­dard IEC 81001-5-1 soon. It deals with how IT secu­ri­ty must be con­sid­ered in the soft­ware life cycle.

As a spe­cial stan­dard for health soft­ware, it sup­ple­ments for exam­ple IEC 62304 and can close gaps that urgent­ly need to be closed. The EU is already plan­ning to har­mo­nize IEC 81001-5-1, cur­rent­ly with the tar­get date May 24, 2024.

Due to the fact that Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) con­tain spe­cif­ic require­ments on cyber­se­cu­ri­ty in their annex­es I, man­u­fac­tur­ers should con­sid­er adopt­ing the cor­re­spond­ing stan­dard if applicable.

Source: Inter­na­tion­al Orga­ni­za­tion for Standardization

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