ISO 17511:2020 体外诊断医疗设备 校准器、真度控制材料和人体样本所赋值的建立计量溯源性的要求

标准编号：ISO 17511:2020

中文名称：体外诊断医疗设备 校准器、真度控制材料和人体样本所赋值的建立计量溯源性的要求

英文名称：In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

发布日期：2020-04

标准范围

本文件规定了必要的技术要求和文件，以建立IVD MDs测量量的校准器、真实性控制材料和人体样本的计量溯源性。人体样本是针对每个IVD MD规定的拟测量样本。人体样本数量值的计量溯源性延伸至最高可用参考系统组件，理想情况下延伸至RMP和认证参考材料（CRM）。所有参与IVD MD校准层次结构中所述任何步骤的各方均应遵守所述要求。这些缔约方包括但不限于（IVD MDs的）制造商、RMP开发商（见ISO 15193）、RM生产商（见ISO 15194）和支持IVD MDs校准层次结构的参考/校准实验室（见ISO 15195）。注1:用于IVD MDs标准化或校准的RMs生产商包括商业和非商业组织，生产RMs供IVD MDs和/或校准实验室的许多最终用户使用，或供单一最终用户医疗实验室使用，如用于实验室校准的测量标准（校准器）-开发了MP。本文件适用于:a） 以数值形式提供测量结果的所有IVD MD，即有理（比率）和/或微分（间隔）标度和计数标度。b） IVD MDs，其中测量结果报告为通过两次测量的比率确定的定性值（即来自被测样本的信号和来自在截止点具有指定浓度或活性的RM的信号），或带有相应判定阈值的计数标度。这也包括IVD MDs，其中结果根据预处理结果按顺序分类-为一个数量建立定量区间。c） 用于验证或评估IVD MDs校准的真实性控制材料的RMs，即一些可交换的CRM和一些外部质量评估（EQA）材料（如果RM的预期用途声明中有说明）。d） IVD MD专用校准器和具有指定值的真实性控制材料，拟与指定的IVD MD一起使用。e） a）和b）中所述的IVD MD，无需最终用户进行校准（即制造商对IVD MD进行工厂校准时）。本文件不适用于:a） IVD MDs的校准器和真实度控制材料，由于其配方，已知被测物量为零；b） 仅用于医学实验室内部质量控制目的的控制材料，用于评估IVD MD的不精确性、其重复性或再现性，和/或用于评估IVD MD结果与之前确定的校准条件相比的变化；c） 仅用于医学实验室内部质量控制目的的控制材料，其供应间隔为建议的可接受值，在计量上无法追溯到更高阶参考系统组件；d） 以标称标度和序数标度报告的属性，其中不涉及震级。注2:标称量表通常用于报告血细胞类型、微生物类型、核酸序列的标识、尿液颗粒的标识。注3:有序量表通常适用于区分为二分法分组的结果（例如“生病”与“健康”），偶尔也适用于区分为非二分法类别的结果，其中结果类别是按等级排序的，但按等级排序的类别不能根据相对差异程度进行区分，例如:。g、 通过目视观察，尿液样本中存在血红蛋白的分级为阴性，+1、+2、+3。

This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.This document is applicable to:a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).This document is not applicable to:a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;d) properties reported as nominal scales and ordinal scales, where no magnitude is involved.NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.NOTE 3 Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g.?sick' vs.?healthy'), and occasionally to results differentiated into non-dichotomous categories where the result categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of relative degree of difference, e.g. negative, +1, +2, +3 for grading of presence of haemoglobin in urine specimens by visual observation.

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