11.100.10 标准查询与下载

YY/T 1789.6-2023 体外诊断检验系统 性能评价方法 第6部分：定性试剂的精密度、诊断灵敏度和特异性

本文件规定了体外诊断检验系统定性试剂的精密度、诊断灵敏度和特异性的性能评价方法。本文件适用于制造商对定性检验的体外诊断检验系统的精密度、诊断灵敏度和特异性评价。文件不适用于结果报告为半定量的体外诊断检验系统的性能评价。本文件不适用于医学实验室的性能验证，也不适用于产品型式检验。

In vitro diagnostic testing system performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents

YY/T 1870-2023 液相色谱-质谱法测定试剂盒通用要求

本文件规定了液相色谱-质谱法检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。本文件适用于以液相色谱-质谱法对人体样本（全血、血清、血浆、尿液等）进行定量检测的试剂盒。

General requirements for liquid chromatography-mass spectrometry assay kits

DB37/T 4565-2022 远程动态心电诊断服务指南

Remote Holter Diagnosis Service Guide

YY/T 1865-2022 BRCA基因突变检测试剂盒及数据库通用技术要求（高通量测序法）

本文件规定了BRCA基因突变检测试剂盒及数据库的试剂盒要求、数据库的数据构成、数据库的数据规范、数据库的数据管理和解读标准。本文件适用于BRCA基因胚系突变检测试剂盒、BRCA基因突变检测数据库和BRCA基因突变解读的质量控制。本文件不适用于BRCA基因体细胞突变检测以及双脱氧法（Sanger）对BRCA基因突变进行检测。

General technical requirements for BRCA gene mutation detection kits and databases (high-throughput sequencing method)

YY/T 1880-2022 血清淀粉样蛋白A测定试剂盒

本文件规定了血清淀粉样蛋白A测定试剂盒的通用技术要求，包括要求、试验方法、标签和使用说明书、包装、运输和贮存。本文件适用于以抗原-抗体免疫反应为基本原理的定量测定人源样本中的血清淀粉样蛋白A的试剂盒，包括免疫比浊法、免疫层析法和化学发光免疫分析法试剂盒。本文件不适用于胶体金免疫层析法定量试剂盒。

Serum amyloid A assay kit

CEN/TS 17811:2022 分子体外诊断检查 尿液和其他体液的预检查过程规范 分离的无细胞 DNA

This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA

BS ISO 21474-2:2022 体外诊断医疗设备 核酸多重分子检测 验证和验证

1   Scope This document gives the general requirements for validation and verification of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex methods used for examination using IVD medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences. This document is intended as guidance for multiplex examinations that either detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic (IVD) examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research and regulatory authorities. This document is not applicable to metagenomics. NOTE An examination procedure developed for a laboratory’s own use is often referred to as a “laboratory developed test,” “LDT,” or “in-house test”.

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification

GSO ISO 21151:2022 体外诊断医疗器械 建立分配给校准器和人体样本的值的计量可追溯性的国际协调协议的要求

This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand. This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples. NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

CEN/TS 17747:2022 分子体外诊断检查 静脉全血中外泌体和其他细胞外囊泡的预检查过程规范 DNA、RNA 和蛋白质

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for DNA, RNA and protein examination from exosomes and other extracellular vesicles during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in isolated DNA, RNA and proteins from enriched exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-free DNA (ccfDNA) examination, both without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in EN ISO 20186 3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma and CEN/TS 17742, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins

CEN/TS 17742:2022 分子体外诊断检查 静脉全血预检查过程规范 从血浆中分离循环无细胞 RNA

This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in EN ISO 20186 1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma

CEN/TS 17688-1:2021 分子体外诊断检查 细针抽吸（FNA）预检查过程规范 第1部分：分离的细胞 RNA

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for RNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine RNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA and EN ISO 20166-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA. This document is not applicable for RNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA

CEN/TS 17688-2:2021 分子体外诊断检查 细针抽吸（FNA）预检查过程规范 第2部分：分离的蛋白质

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for protein examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine proteins isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins and EN ISO 20166-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins. This document is not applicable for protein examination by immunohistochemistry. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins

CEN/TS 17688-3:2021 分子体外诊断检查 细针穿刺（FNA）预检查过程规范 第3部分：分离的基因组 DNA

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine gDNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA and EN ISO 20166-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA. This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA

YY/T 1180-2021 人类白细胞抗原（HLA）基因分型检测试剂盒

Human Leukocyte Antigen (HLA) Genotyping Test Kit

YY/T 1828-2021 抗缪勒管激素测定试剂盒（化学发光免疫分析法）

Anti-Müllerian hormone assay kit (chemiluminescence immunoassay)

YY/T 1160-2021 癌胚抗原（CEA）测定试剂盒

Carcinoembryonic Antigen (CEA) Assay Kit

YY/T 1831-2021 梅毒螺旋体抗体检测试剂盒（免疫层析法）

Treponema pallidum antibody detection kit (immunochromatographic method)

YY/T 1836-2021 呼吸道病毒多重核酸检测试剂盒

Respiratory virus multiplex nucleic acid detection kit

YY/T 1826-2021 B群链球菌核酸检测试剂盒（荧光PCR法）

Group B Streptococcus nucleic acid detection kit (fluorescence PCR method)

YY/T 1789.2-2021 体外诊断检验系统 性能评价方法 第2部分：正确度

Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy