11.100.10 标准查询与下载

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)

BS ISO 20916:2019 体外诊断医疗设备 使用人类受试者样本进行临床性能研究 良好的学习习惯

What is ISO 20916 - Clinical performance studies of In vitro diagnostic (IVD) medical devices about? ISO 20916 discusses In vitro diagnostic (IVD) medical devices. ISO 20916 is an international standard on clinical performance studies of In vitro diagnostic medical devices. ISO 20916 outlines 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. ISO 20916 identifies the principles that underpin clinical performance studies and specifies general requirements intended to: Ensure the conduct of the clinical performance study that led to reliable and robust study results Define the responsibilities of the sponsor and principal investigator Assist sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of In-vitro medical devices Protect the rights, safety, dignity, and well-being of...

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

BS EN ISO 20186-1:2019 分子体外诊断检查 静脉全血预检过程规范-分离细胞RNA

What is ISO 20186-1- Pre-examination processes for venous whole blood about? ISO 20186 discusses molecular in vitro diagnostic examinations. ISO 20186-1 is the first part of a multi-part series that lays out guidelines on the handling, storage, processing, and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. ISO 20186-1 covers specimens collected in venous whole blood collection tubes. ISO 20186-1 helps you to standardize the entire workflow from specimen collection to the cellular RNA examination and helps you to determine important influencing factors. Note 1: Different dedicated measures are taken for stabilizing blood cell-free circulating RNA and RNA in exosomes circulating in the blood. These are not described in ISO 20186-1 . Note 2: Different dedicated measures are taken for collecting, stabilizing, transporting, and storing capillary blood as well as for collecting and storing blood by paper-based technologies or ...

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA

BS EN ISO 20184-2:2018 分子体外诊断检查 冷冻组织预检验过程规范-分离蛋白

What is ISO 20184-2- Isolated protein for pre-examination processes for frozen tissue about?    ISO 20184 is an international standard that discusses pre-examination processes for frozen tissue for molecular in vitro diagnostic examinations. ISO 20184-2 provides the best industry guidance on Isolated protein to ensure reliable results are produced that are comparable to other laboratories.   ISO 20184-2 is the second part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of frozen tissue specimens intended for protein examination during the pre-examination phase before a molecular assay is performed.

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

BS EN ISO 20166-1:2018 分子体外诊断检查 福尔马林固定石蜡包埋 (FFPE) 组织预检查过程规范 分离 RNA

What is ISO 20166‑1- Isolated RNA for pre-examination processes about?    ISO 20166 is an international standard that discusses molecular in vitro diagnostic examinations. ISO 20166‑1 provides the best industry guidance on Isolated RNA examination during the pre-examination phase to produce reliable results that are comparable to other laboratories.   ISO 20166‑1 is the first part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.  

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated RNA

BS EN ISO 20166-2:2018 分子体外诊断检查 福尔马林固定石蜡包埋 (FFPE) 组织预检查过程规范 分离蛋白

What is ISO 20166-2- Isolated protein for pre-examination processes about?    ISO 20166 is an international standard that discusses molecular in vitro diagnostic examinations. ISO 20166‑2 provides the best industry guidance on Isolated protein examination during the pre-examination phase to produce reliable results that are comparable to other laboratories.     ISO 20166-2 is the second part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.

Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated proteins

BS EN ISO 20166-3:2019 分子体外诊断检查 福尔马林固定石蜡包埋 (FFPE) 组织预检查过程规范 分离 DNA

What is ISO 20166-3- In- vitro diagnostic examinations on Isolated DNA about? ISO 20166 discusses molecular in vitro diagnostic examinations. ISO 20166-3 is the third part of a multi-part standard that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. ISO 20166-3 assists to improve the pre-examination phase of Isolated DNA Molecular in vitro diagnostics, including molecular pathology, has enabled significant progress in medicine. However, the profiles and/or integrity of these molecules can change drastically during specimen collection, transport, storage, and processing. Therefore, it is essential to take special measures to minimize the DNA changes and modifications for subsequent examination. Note: International, national, or regional regulations or requirements can also apply to specific topics covered in this document. Who is ISO 20166-3-

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated DNA

BS EN ISO 20184-1:2018 分子体外诊断检查 冷冻组织预检过程规范-分离RNA

What is ISO 20184-1- Isolated RNA for pre-examination processes about?    ISO 20184 is an international standard that discusses pre-examination processes for frozen tissue for molecular in vitro diagnostic examinations. ISO 20184-1 provides the best industry guidance on Isolated RNA to ensure reliable results are produced that are comparable to other laboratories.    ISO 20184-1 is the first part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.

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

GSO ISO 18113-3:2016 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

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to: a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for self-testing.

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

GSO ISO 18113-4:2016 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

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use.

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

GSO ISO 18153:2016 体外诊断医疗器械 生物样品中数量的测量 指定校准物和控制材料的酶催化浓度值的计量溯源

This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a) requirements for the design or selection of a reference measurement procedure; b) quantities involving mass of enzyme or immunoreactivity of enzymes; c) control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); d) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; f) properties involving nominal and ordinal scales.

In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials

GSO ISO 18113-5:2016 体外诊断医疗器械 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

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use.

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

GSO ISO 18113-2:2016 体外诊断医疗器械 制造商提供的信息（标签） 第2部分：专业用体外诊断试剂

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.

In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use

PD CEN/TS 16945:2016 分子体外诊断检查-尿,静脉血清和血浆中代谢组学前检查程序规范

This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.

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

GOST EN 14136-2016 体外诊断检查程序性能评定用外部质量评定方案的使用

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

GOST EN 13975-2016 体外诊断医疗器械验收试验使用取样程序. 统计特性

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects