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Название / перевод рус
Self-testing IVD Medical Device /
IMDRF/IVD WG/N64FINAL:2021 (formerly GHTF/SG1/N045:2008)
an IVD medical device intended for use by a lay user who is responsible for collecting the data or specimen, by themselves and on themselves, relying solely on the instructions provided by the manufacturer. This use can also include performing the test and interpreting the results by themselves and on themselves. (Modified from IMDRF/GRRP WG/N47FINAL:2018)В сообщении, пожалуйста, укажите известную информацию, касающуюся терминов глоссария