11.100.10 标准查询与下载

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 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 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 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 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

KS P ISO 18113-4:2015 牙科旋转器械.柄.第4部分:塑料柄

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

KS P ISO 18113-5:2015 牙科旋转器械.柄.第5部分:塑料柄

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

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 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

EN ISO 15197:2015 体外诊断测试系统.血糖监测系统进行糖尿病自我管理(ISO 15197:2013)

Die vorliegende Internationale Norm legt Anforderungen an In-vitro-Glukosemesssysteme zur Messung von Glukosekonzentrationen in Kapillarblutproben für spezifische Design-Verifizierungsverfahren und zur Validierung der Leistungsfähigkeit durch die vorgesehenen Anwender fest. Diese Systeme sind für die Selbstmessung durch Laien zur Führung des Diabetes mellitus vorgesehen. Diese Internationale Norm gilt für die Hersteller derartiger Systeme und für diejenigen sonstigen Organisationen (z. B. Zulassungsbehörden und Institutionen zur Konformitätsbeurteilung), die für die Beurteilung der Leistungsfähigkeit dieser Systeme verantwortlich sind. Diese Internationale Norm: liefert keine umfassende Bewertung aller möglichen Faktoren, die die Leistungsfähigkeit dieser Systeme beeinflussen können; gilt nicht für die Glukosekonzentrationsmessung zur Diagnose des Diabetes mellitus; behandelt nicht die medizinischen Aspekte der Führung des Diabetes mellitus; gilt nicht für Messverfahren, bei denen die Messwerte auf einer Ordinalskale dargestellt werden (z. B. visuelle, halbquantitative Messverfahren) oder für kontinuierliche Glukosemesssysteme; gilt nicht für Blutzuckermessgeräte in medizinischen Applikationen, die nicht für den Gebrauch der Selbstüberwachung zum Management von Diabetes mellitus gedacht sind.

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

EN ISO 23640:2015 体外诊断医疗器械,体外诊断试剂的稳定性评价(ISO 23640:2011)

Diese Internationale Norm gilt für die Haltbarkeitsprüfung von In-vitro-Diagnostika, einschließlich Reagenzien, Kalibriermaterialien, Kontrollmaterialien, Verdünnungsmitteln, Pufferlösungen und Reagenz-Kits, nachstehend IVD-Reagenzien genannt. Diese Internationale Norm kann auch für Primärprobensammler gelten, die Substanzen enthalten, die der Haltbarmachung von Proben dienen oder mit denen Reaktionen zur weiteren Behandlung der Probe in dem Sammler angeregt werden. Diese Internationale Norm legt allgemeine Anforderungen an die Haltbarkeitsprüfung fest und enthält spezielle Anforderungen an die Echtzeit- und beschleunigte Haltbarkeitsprüfung für die Gewinnung von Daten: zur Festlegung der Haltbarkeitsdauer von IVD-Reagenzien, einschließlich geeigneter Transportbedingungen, um sicherzustellen, dass die Produktspezifikationen erhalten bleiben; zur Festlegung der Haltbarkeit des in Gebrauch befindlichen IVD-Reagenz nach dem ersten Öffnen des Primärbehälters; BEISPIEL Haltbarkeit im Analysengerät, Haltbarkeit nach Wiederherstellung, Haltbarkeit der geöffneten Ampulle/Flasche; zur Überwachung der Haltbarkeit von bereits in Verkehr gebrachten IVD-Reagenzien; zur Bestätigung der Haltbarkeitsangaben nach Änderungen des IVD-Reagenz, die Einfluss auf dessen Haltbarkeit haben könnten. Diese Internationale Norm gilt nicht für Instrumente, Apparate, Ausrüstung, Systeme oder Probengefäße oder die zur Untersuchung vorgelegte Probe.

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

CAN/CSA-ISO 15197:2015 体外诊断测试系统 用于管理糖尿病的自我测试的血糖监测系统的要求（第二版）

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (Second Edition)

IEC 61010-2-101:2015 测量、控制和实验室用电气设备的安全要求.第2-101部分:实验室诊断(IVD)医疗设备的特殊要求

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

GOST R ISO 18113-1-2015 体外诊断医疗器械. 制造商提供的信息 (标签). 第1部分. 术语, 定义和通用要求

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

GOST R ISO 16256-2015 临床实验室测试和体外诊断测试系统. 检测抗菌剂抗传染病中酵母真菌体外活性的基准方法

Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

GOST R ISO 15193-2015 体外医疗器械. 生物有机体试样的数量测量. 参考测量程序的内容和表示要求

In vitro medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures

GOST R ISO 18113-3-2015 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