C38 普通诊察器械 标准查询与下载

DIN EN ISO 15197:2015 体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求(ISO 15197-2013).德文版本EN ISO 15197-2015

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015

DIN EN ISO 23640:2015 体外诊断医疗器械.体外诊断试剂的稳定性评定(ISO 23640-2011).德文版本EN ISO 23640-2015

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015

PD CEN/TS 16835-2:2015 分子体外诊断检查.静脉全血预审流程的规范.第2部分:脱氧核糖核酸染色体组的分离

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures need to be taken for preserving blood circulating cell free DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification. DNA from pathogens present in blood is not covered by this Technical Specification.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA

PD CEN/TS 16835-3:2015 分子体外诊断检查.静脉全血预审流程的规范.第3部分:从血浆中分离的游离的循环细胞游离脱氧核糖核酸

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood ccfDNA profiles can change significantly after blood collection from the donor (e. g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage. Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in CEN/TS 16835-2. NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes. DNA from pathogens present in blood is not covered by this Technical Specification.

Molecular in vitro diagnostic e xaminations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma

IEC TS 62791:2015 超声学.脉冲回波扫描仪.适用于多种换能器类型的灰度医用超声扫描仪的低回波球体模型和性能测试方法

This Technical Specification defines terms and specifies methods for quantifying the imaging performance of real-time, ultrasound B-mode scanners. The types of transducers used (see sections 7.6 and 10.7 of [1]) with these scanners include a) phased array, b) linear arrays, c) convex arrays, d) mechanical sector scanners, e) 3-D probes operating in 2-D imaging mode (see Annex K), f) 3-D probes operating in 3-D imaging mode for a limited number of sets of reconstructed 2-D images (see Annex K). The test methodology is applicable for transducers operating in the 2 MHz to 15 MHz frequency range.

Ultrasonics - Pulse-echo scanners - Low-echo sphere phantoms and method for performance testing of gray-scale medical ultrasound scanners applicable to a broad range of transducer types

BS PD CEN/TS 16827-1:2015 分子体外诊断检查. 石蜡包埋组织的预检测过程的规格. 分离核糖核酸

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

BS PD CEN/TS 16826-1:2015 分子体外诊断检查. 快速冷冻组织的预检测过程的规格. 分离核糖核酸

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

BS PD CEN/TS 16826-2:2015 分子体外诊断检查. 快速冷冻组织的预检测过程的规格. 分离蛋白

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

PD CEN/TS 16827-3:2015 分子体外诊断检查.石蜡包埋组织预审流程的规范.第2部分:脱氧核糖核酸

This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations, changes in the methylation status or even structural changes which can lead to e. g., spurious copy number changes in array-CGH profiles. These modifications of the DNA molecules can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA analysis.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA

PD CEN/TS 16827-1:2015 分子体外诊断检查.石蜡包埋组织预审流程的规范.第1部分:核糖核酸的提取

This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA

PD CEN/TS 16827-2:2015 分子体外诊断检查.石蜡包埋组织预审流程的规范.第2部分:蛋白质的分离

This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for the analysis of extracted proteins during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Protein profiles and protein-protein interactions in tissues can change drastically before and after collection (due to e. g., gene induction, gene down regulation, protein degradation). Protein species amounts can change differently in tissues from different donors / patients. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environment conditions after the tissue removal from the body. Furthermore, the formalin fixation and paraffin embedding process leads to modifications of the protein molecules, which can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent protein analysis. This document is not applicable for protein analysis by immunohistochemistry.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins

PD CEN/TS 16826-1:2015 分子体外诊断检查.冰冻组织预审流程的规范.第1部分:核糖核酸的提取

This Technical Specification gives recommendations for the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). RNA profiles in tissues can change significantly before and after collection and can change differently in tissues from different donors / patients. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis. Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in this document.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA

PD CEN/TS 16826-2:2015 分子体外诊断检查.冰冻组织预审流程的规范.第2部分:蛋白质的分离

This Technical Specification gives recommendations for the handling, documentation and processing of frozen tissue specimens intended for the analysis of extracted proteins during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). Protein profiles and protein-protein interactions in tissues can change drastically before and after collection (due to e. g., gene induction, gene down regulation, protein degradation). Protein species amounts can change differently in tissues from different donors / patients. The expression of genes can be influenced by the given treatment or medical intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environment conditions after the tissue removal from the body. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent protein analysis. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. In addition this document is not applicable for protein analysis by immunohistochemistry.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins

PD CEN/TS 16835-1:2015 分子体外诊断检查.静脉全血预审流程的规范.第1部分:核糖核酸细胞的分离

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA

BS EN ISO 15197:2015 体外诊断测试系统 糖尿病管理中自我检测血糖监测系统的要求

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

BS EN ISO 23640:2015 体外诊断医疗设备 体外诊断试剂稳定性评价

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

DIN EN ISO 11070:2015 一次性使用无菌血管内导引器械, 扩张器和引导线 (ISO 11070-2014); 德文版本EN ISO 11070-2014

Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014); German version EN ISO 11070:2014

GOST R ISO 10651-5-2015 医用肺通气机. 基本安全和基本性能的特殊要求. 第5部分. 气体驱动急救人工呼吸器

Lung ventilators for medical use. Part 5. Particular requirements for basic safety and essential performance for gas-powered emergency resuscitators

DIN EN ISO 80601-2-69:2014 医疗电气设备. 第2-69部分: 氧浓缩设备的基本安全和基本性能的详细要求 (ISO 80601-2-69-2014); 德文版本EN ISO 80601-2-69-2014

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014); German version EN ISO 80601-2-69:2014

DIN EN ISO 81060-2:2014 非侵入式血压计. 第2部分: 自动测量类型的临床研究 (ISO 81060-2-2013); 德文版本EN ISO 81060-2-2014

Non-invasive sphygmomanometers - Part 2: Clinical invastigation of automated measurement type (ISO 81060-2:2013); German version EN ISO 81060-2:2014