11.100.10 标准查询与下载

YY/T 1160-2021 癌胚抗原（CEA）测定试剂盒

Carcinoembryonic Antigen (CEA) Assay Kit

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

YY/T 1164-2021 人绒毛膜促性腺激素（HCG）检测试剂盒（胶体金免疫层析法）

Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatography)

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 1785-2021 氨基酸和肉碱检测试剂盒(串联质谱法)

Amino acid and carnitine detection kit (tandem mass spectrometry)

21/30416045 DC BS EN ISO 18113-5 体外诊断医疗设备 制造商提供的信息（标签）-第 5 部分：用于自检的体外诊断仪器

BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 5. In vitro diagnostic instruments for self-testing

21/30416041 DC BS EN ISO 18113-4 体外诊断医疗设备 制造商提供的信息（标签）-第4部分：自检用体外诊断试剂

BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 4. In vitro diagnostic reagents for self-testing

21/30416033 DC BS EN ISO 18113-2 体外诊断医疗设备 制造商提供的信息（标签）-第 2 部分：专业用体外诊断试剂

BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 2. In vitro diagnostic reagents for professional use

21/30416029 DC BS EN ISO 18113-1 体外诊断医疗设备 制造商提供的信息（标签） 第 1 部分：术语、定义和一般要求

BS EN ISO 18113-1. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 1. Terms, definitions, and general requirements

21/30416037 DC BS EN ISO 18113-3 体外诊断医疗设备 制造商提供的信息（标签） 第 3 部分：专业用体外诊断仪器

BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 3. In vitro diagnostic instruments for professional use

GSO ISO 20916:2021 体外诊断医疗器械 使用人体样本进行临床性能研究 良好研究实践

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

BS EN ISO 23118:2021 分子体外诊断检查 尿液、静脉血清和血浆代谢组学预检过程规范

What is ISO 23118 about?   ISO 23118 addresses Molecular in vitro diagnostic examinations specifies requirements and gives recommendations for the handling, documentation, and processing of urine, venous blood plasma, and serum intended for metabolomics analysis in the pre-examination processes.    ISO 23118 is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.   Who is ISO 23118 for?

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

BS EN ISO 20184-3:2021 分子体外诊断检查 冷冻组织预检查过程规范 分离DNA

What is ISO 201843 about?   ISO 201843 is one of a series of a document about molecular in vitro diagnostic examinations requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed .   Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.   Note: International, national, or regional regulations or requirements can also apply to specific topics covered in this document.  Who is ISO 20184-3 for?   ISO 20184-3

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated DNA

KS P ISO 18113-4-2020 体外诊断医疗器械 制造商提供的信息（标签） 第4部分：自检用体外诊断试剂

In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing

KS P ISO 18113-3-2020 体外诊断医疗器械 制造商提供的信息（标签） 第3部分：专业用体外诊断仪器

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

KS P ISO 18113-5-2020 体外诊断医疗器械 制造商提供的信息（标签） 第5部分：自检体外诊断仪器

In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing

BS ISO 21474-1:2020 体外诊断医疗设备 核酸多重分子检测 核酸质量评价的术语和一般要求

What is ISO 21474-1 about?    ISO 21474 discusses In vitro diagnostic medical devices on multiplex molecular testing for nucleic acids. ISO 21474-1 outlines provide the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest.    ISO 21474-1 is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory-developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.  

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation

BS ISO 21151:2020 体外诊断医疗设备 对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

What is ISO 21151 about?    ISO 21151 discusses the metrological traceability of values assigned to calibrators and human samples for In vitro diagnostic medical devices (IVDMD). ISO 21151 outlines 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 not 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.   ISO 21151 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...

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

CEN/TS 17390-1:2020 分子体外诊断检查 静脉全血中循环肿瘤细胞（CTC）预检查过程规范 第1部分：分离的 RNA

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor Cells (CTCs) 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. 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. This document does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA in pathogens present in blood is not covered by this document. 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 circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

EN ISO 20186-3:2019 分子体外诊断检查 - 血液预检过程规范 - 细胞RNA - 第3部分:血浆中分离的循环无细胞DNA

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination 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 are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)