DS/EN ISO 17511:2021 体外诊断医疗器械 建立校准器、真实性控制材料和人体样本数值计量溯源性的要求（ISO 17511:2020）
In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)