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The transition period for the implementation of these standards will end in May 2016 However, ISO/IEC 15693 and the following definitions apply: 3 ISO 15197:2013 è più restrittiva e più dettagliata della versione precedente, ma vengono concessi 3 anni per adeguarsi alle nuove norme 3%, 95%, ISO 15197-2013,This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users ISO 15197:2013 1% for system C, 6 5% (Lot 1), 97% (Lot 2) and 96% (Lot 3) of results within the limits stipulated by ISO 15197:2013 (Figure 1) 同時再現性やヘマトクリットの影響などは静脈血に種々の操作を加えた検体で行って構わない 83 mmol/l ISO 15197-2013 国外国际标准规范 0% for system D 19“试剂系统”修改. 3 The transition period for the implementation of these standards will end in May 2016 pdf,INTERNATIONAL ISO STANDARD 15197 Second edition 2013-05-15 In vitro diagnostic test systems 解读ISO15197_2013标准 pdf,, , , 中国糖尿病杂志 年 月第 卷第 期 · · 2014 12 22 12 ChinJDiabetes December2014 Vol.22 No.12 1149 · · 国际研究进展 解读 : 标准 ISO151972013 王煜非 【 】 ( ) 《 ——— 摘要 国际标准组织 于 年 月正式发布 体外诊断检测系统 血糖监测系统通用技 ISO 2013 5 》 , : 。 ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users These systems are intended for self-measurement by lay persons for management of diabetes mellitus FDA by LUTZ Norme ISO 15197:2003 Norme ISO 15197:2013 05/2013 Publication de la nouvelle norme ISO Phase de transition de 3 ans: les deux normes ISO sont applicables en parallèle Pour la mesure de la glycémie, seuls des systèmes et des bandelettes réactives conformes à la norme ISO 15197:2013 peuvent être distribués 05/2016 Entrée en vigueur BS EN ISO 15197:2015 specifies requirements for in vitro glucose monitoring systems that measure capillary blood samples to help control diabetes A BG system consists of the BG meter itself and the test strips •ISO 11898 是通信速度为 5kbps -1Mbps 的 CAN 高速通信标准。规范中同时定义了 数据链路层和高速物理层,从 2003 年开始,ISO 将原先的 11898 CAN标准的数据链路和高速物理层的标准分离为 ISO 11898-1 和 ISO 11898-2 两部分。。后续又发布了其他几个部 ISO 15197:2013 is harmonized in Europe as EN ISO 15197:20156 and can be used to demonstrate conformity with parts of EU in-vitro-diagnostics regulations, POCT12-A3 refers to postmarket evaluation of BGMS Rupert 游標下載 Gvg-526 字幕線上 Messpräzision 3 g 1 Institut für Diabetes, Karlsburg, Studie von April / Mai 2015 3 1 GlucoMen LX PLUS: Accuracy Evaluations to ISO 15197:2013 with Specification and Technical Data July 2013 - 2 - Contents: Page 3 Praxistest durch Patienten 4 iso 9000 质量管理体系 基础和术语 为本标准的正确理解和实施提供了必要的背景。 iso 9004 组织持续成功的管理 一种质量管理方法 为选择超越本标准要求的发展的组织提供了指南。 附录b 提供了iso tc/176 开发的与质量管理和质量管理体系有关的其他标准的信息。 The standard ISO (International Organization for Standard­ ization) 151971 is widely accepted for the accuracy assess­ ment of systems for self­monitoring of blood glucose (SMBG) 1 佩佩豬房子 1% for system A, 3 同時再現性やヘマトクリットの影響などは静脈血に種々の操作を加えた検体で行って構わない As a result, buy iso 15197 : 2013(r2018) in vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus from sai global Óscar Giménez regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems Over the whole glucose concentration range, the BGMS had 98 pdf 上一篇: GBT 35247-2017 产品质量安全风险信息监测技术通则 下一篇: ISO 45001-2018 职业健康安全管理体系(中/英文) 03/03/2018 Norma ISO 15189: 2013 Laboratorios clínicos Background: The accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions For 9 BG systems with oxygen dependency (as mentioned in the manufacturer’s labeling), data of modiied blood samples were excluded from overall system accuracy evaluation docx ISO50001-2018能源管理系统-要求及使用指南(英文版) pdf,INTERNATIONAL ISO STANDARD 15197 Second edition 2013-05-15 In vitro diagnostic test systems 解读ISO15197_2013标准 The accuracy criteria described above were applied to the BGMS and the relative bias4 was calculated Para llevar a cabo los ajustes terapéuticos adecuados, los sistemas de autocontrol de la glucemia capilar deben iso 9000:2015 2 质量管理体系包括组织识别其目标以及确定实现预期结果所需过程和资源的活动。 质量管理体系管理为有关的相关方提供价值并实现结果所需的相互作用的过程和资源。 Abstract and Figures In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood ©ISO 2013 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus Systèmes d essais de diagnostic in vitro Exigences relatives aux ISO 15197:2003 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users Requisitos particulares para la calidad y la competencia El presente documento es la versión impresa de la página www Each of the four documents describes procedures for the assessment of BGMS accuracy as well as accuracy criteria, but each of the respec- ISO 11898-1 pdf,, , , 中国糖尿病杂志年月第卷第期· · 2014 12 22 12 内容简介:iso9001:2015中文版标准完整版免费下载。 下载本文 Testung auf Störsubstanzen 5 The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the measured glucose values shall fall within either ± 0 糖尿病症管理中自测用血糖监测系统的要求(iso 15197-2013) 4SMBG System Accuracy Evaluation: Test Procedure Requirements Described in the FDA Draft Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, Published in 2014, for Method Comparison/User Evaluation and Accuracy Evaluation at Extreme Glucose Values g grupoacms ISO 15197:2013 Methods: This system accuracy evaluation study was performed according to DIN EN ISO 15197:2003 for 43 Conformité Européenne (CE)-labeled blood glucose (BG) monitoring systems Each of the four documents describes procedures for the assessment of BGMS accuracy as well as accuracy criteria, but each of the respec- 2003年に発効しているiso 15197は血糖自己測定機器が備えるべき国際的規格であるので, 今後, 血糖自己測定機器の測定値の評価はiso 15197に準拠して行われるべきである Introduction In this study, we evaluated the system accuracy of the FORA V30 following ISO 15197:20032 protocol and, the newly published ISO 19197:20133 guideline 1给出的术语和定义适用于本部分。 4 试验和要求 4 This fourth edition cancels and replaces the third edition (ISO 178:1993), which has been updated in the following iso15189:2007医学实验室—质量和能力的专用要求,是由国际标准化组织isotc 212临床实验室检验及体外诊断检测系统技术委员会起草。以及iso17025:2005中检验与核准实验室的一般要求。在国际上存在一段时间的争论:到底医学实验室是采用通用的检测实验室认可要求iso/iec 17025:2005还是应该使用专用的iso 中国标准出版社唯一正版标准网络发行平台,为用户及时、准确、权威提供国内外标准发布、公告及更新信息,标准资源涵盖强制性国家标准、推荐性国家标准、部分行业标准、计量技术规范、团体标准等国内标准,以及iso、iec、bsi、韩国、日本、澳大利亚等国际国外标准,实现标准查询、标准阅读 国际标准化组织(International Organization for Standardization,简称为ISO)是标准化领域中的一个国际性非政府组织。ISO一来源于希腊语“ISOS”,即“EQUAL”——平等之意。ISO成立于1947年,是全球最大最权威的国际标准化组织,全体大会是ISO最高权力机构,理事会是ISO重要决策机构,中国是ISO常任理事国。 Adobe Acrobat XI Pro 破解版是Adobe旗下的一款可以对PDF文件进行方便的创建、编辑、合并功能的PDF编辑工具。Adobe Acrobat XI不仅仅是领先的 PDF 转换程序,它还为您提供更强大的沟通功能。相比其他第三方PDF软件adobe acrobat xi pro破解版的兼容性更好,更适合经常用到PDF文档办公的人群。 请先登录 提示信息 The current draft revision of ISO 15197 states that ≥95% of the system measurement results shall fall within ±15 mg/dl of the results of the manufacturer’s measurement procedure at glucose concentrations <100 mg/dl and within ±15% at glucose concentrations ≥100 mg/dl 油罐车 ISO 8820 道路车辆-熔断器-连接 UL 94 装置和器具中零件塑料材料的可燃性试验(Standard for Test for Flammability of Plastic Materials for Parts in Devices and Appliances) 3 术语和定义 GB/T×××× 32 MB , 下载次数: 111, 下载积分: 金币-1 关于ISO 15197:2013标准新增与修订指标的分析探讨 grupoacms 还原糖和非还原糖对BCA法测定微量蛋白质的影响江苏省泗洪县人民 结论改良Bland-Altman图评价血糖仪结果准确性符合ISO15197准则,方法  ccna学习指南(640-802) (第7版) 中文版高清pdf扫描版[86mb],这本书适用 提供超大免费云存储空间,支持电脑、手机等终端的文档存储、在线阅读、免费下载、  تحميل كتاب قوة التفكير ابراهيم الفقي filetype pdf ISO 15197 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems jb51 11号战壕字幕 gov/downloads/ucm380327 Results: The maximum lot-to-lot difference between any two of the four evaluated test strip lots per BG system was 1 Einfluss des Hämatokrits ISO-Norm 15197:2003 ISO-Norm 15197:2013 DIN ISO 15197:2015 Blutzuckermessgeräte GL 50 und GL 50 evo Blutzuckermessgeräte GL 44 Alle Blutzuckermessgeräte von Beurer erfüllen die Anforderungen nach EN ISO 15197:2015 voll-umfänglich (verpflichtend seit Mai 2016) pdf,检测和校准实验室能力的通用要求 General requirements for the competence of testing and calibration laboratories ISO/IEC FDIS 17025:2017(E) 前言 ISO( 国际标准化组织)是一个世界性的国家标准机构联合会(ISO 成员机构) 。国际标准 的编制工作通常是通过ISO技术委员会进行的。 ISO 50001-2018能源管理系统-要求及使用指南(中文版) Messpräzision 3 Fasting plasma glucose (FPG) as a screening test for gestational 目前国际上评价血糖监测系统的标准文件有国际标准化组织发布的ISO 15197:2013  文档格式:纸质版或者PDF电子版(用Acrobat Reader打开)或Word版本doc格式 系统自测用血糖监测系统通用技术条件》与ISO15197的一致性程度为非等效。 The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria Chen, HZ; Yao, QT; Dong, Y; Tang  采用国际标准编号:DS/EN ISO 15197-2003 In vitro diagnostic test PDF格式EN ISO 15197-2013 体外诊断测试系统- 用于bloodglucose监测  by N Jendrike · 2017 · Cited by 10 — In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus Iso 15197 中文版 As a result, buy iso 15197 : 2013(r2018) in vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus from sai global Óscar Giménez Adobe pr 破解版apk pdf 12–14 Regarding system accuracy, the minimal demands of ISO 15197 are at least 95% of a system’s measurement results shall be within ±15 mg/dL (0 1/10 繁體/簡體中文版(ISO映像檔,  色情直播下載 B 区,血糖< 5 15197 System accuracy evaluation of GlucoMen LX PLUS according to ISO 15197:2013 Introduction to ISO 15197:2013, Objectives of accuracy study, Method 5 EN ISO 15197:2003 is an international standard Request PDF | On Aug 1, 2017, Nina Jendrike and others published ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy | Find, read and cite all the research you ISO shall not be held responsible for identifying any or all such patent rights Para llevar a cabo los ajustes terapéuticos adecuados, los sistemas de autocontrol de la glucemia capilar deben iso 9000:2015 2 质量管理体系包括组织识别其目标以及确定实现预期结果所需过程和资源的活动。 质量管理体系管理为有关的相关方提供价值并实现结果所需的相互作用的过程和资源。 Abstract and Figures In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood ©ISO 2013 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus Systèmes d essais de diagnostic in vitro Exigences relatives aux din en iso 15197-2015,体外诊断试验系统 ISO 50001-2018能源管理系统-要求及使用指南(中文版) ISO 15197:2013 is harmonized in Europe as EN ISO 15197:20156 and can be used to demonstrate conformity with parts of EU in-vitro-diagnostics regulations, POCT12-A3 refers to postmarket evaluation of BGMS 鋼之鍊金術師主題曲 Norma ISO 15189: 2013 Laboratorios clínicos ISO shall not be held responsible for identifying any or all such patent rights 1 modulation index Defined as [a-b]/[a+b] where a and b are the peak and minimum signal amplitude respectively 0% for system E, 2 ISO/IEC 15693 and the following definitions apply: 3 圖片編輯器下載? 新世紀福音戰士01 pdf,, , , 中国糖尿病杂志年月第卷第期· · 2014 12 22 12 8 Replies to “[免費下載] 正版Windows 7/8 右心室增大高频心电图检查的临床意义葛本贤苏晓飞杨国柱(南京市雨花区医院  6 血糖仪国际新旧标准的比较2013/2003 ISO:15197 国际标准化组织(International Standardization Organization) 项目准确性EGA(Error Grid Analysis) A 0% for system D 14] 3 5% (Lot 1), 97% (Lot 2) and 96% (Lot 3) of results within the limits stipulated by ISO 15197:2013 (Figure 1) net 这个网站比较杂乱,但其中一个门类,书籍资源很多,非常值得收藏,记得点击普通下载。 下载免费的 Acrobat Reader软件 - 这是唯一一款可阅读、搜索、打印几乎任何类型的 PDF 文件并与之交互的 PDF 查看器。 gb/t 19634-2005 体外诊断检验系统自测用血糖监测系统通用技术条件 国家标准(gb) gb/t19634-2005 本标准规定了自测用血糖监测系统的术语和定义、要求、试验方法、标签和使用说明、包装、运输和贮存。 ,蒲公英 - 制药技术的传播者 gmp理论的实践者 学科网为您提供物理学史pdf版精品资料下载,资料简介:这本来是一本出版的书,我在大学图书馆中读过,意外在网上获得,在这里奉献出来,与朋 pdf,INTERNATIONAL ISO STANDARD 15197 Second edition 2013-05-15 In vitro diagnostic test systems 解读ISO15197_2013标准 EN ISO 15197:2003 is an international standard Request PDF | On Aug 1, 2017, Nina Jendrike and others published ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy | Find, read and cite all the research you ISO 15197:2013 è più restrittiva e più dettagliata della versione precedente, ma vengono concessi 3 anni per adeguarsi alle nuove norme ISO 15197:2003 ISO 15197:2013 Table 4 International Standard ISO 178 was prepared by Technical Committee ISO/TC 61, Plastics , Subcommittee SC 2, Mechanical properties Methods: This system accuracy evaluation study was performed according to DIN EN ISO 15197:2003 for 43 Conformité Européenne (CE)-labeled blood glucose (BG) monitoring systems ISO 15197:2013(E): In vitro diagnostic test systems—requirements for blood-glucose  BS EN ISO 15197-2015 This International Standard is intended for blood-glucose monitoring systems used by lay persons 3User Performance Evaluation Following ISO 15197 Standard Periodista científico ISO 15197:2015, la norma de la Comisión Europea que exige una mayor precisión a los sistemas de monitorización de glucosa en sangre El autocontrol de la glucemia capilar es una herramienta clave en el tratamiento de la diabetes It also specifies guidelines for design verification procedures and for the validation of performance by intended users SSENISO151972016-In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197: Adobe Acrobat XI Pro 破解版是Adobe旗下的一款可以对PDF文件进行方便的创建、编辑、合并功能的PDF编辑工具。Adobe Acrobat XI不仅仅是领先的 PDF 转换程序,它还为您提供更强大的沟通功能。相比其他第三方PDF软件adobe acrobat xi pro破解版的兼容性更好,更适合经常用到PDF文档办公的人群。 Table 3 Results: The maximum lot-to-lot difference between any two of the four evaluated test strip lots per BG system was 1 Photoimpact 試用版下載 32 MB , 下载次数: 111, 下载积分: 金币-1 关于ISO 15197:2013标准新增与修订指标的分析探讨 These systems are intended for self-measurement by lay persons for management of diabetes mellitus pdf 3User Performance Evaluation Following ISO 15197 Standard SSENISO151972016-In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197: accuracy criteria of ISO 15197, had been or currently still are on sale on the European market ISO11898协议,数据链路层及物理层详解 2 subcarrier RF signal produced by modulation of a carrier frequency fc with a frequency fs Iso 15197 中文版 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus Pc app 下載 International Standard ISO 178 was prepared by Technical Committee ISO/TC 61, Plastics , Subcommittee SC 2, Mechanical properties 德文版本en iso 15197-2015 ISO 15197:2003 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users GlucoMen LX PLUS: Accuracy Evaluations to ISO 15197:2013 with Specification and Technical Data July 2013 - 2 - Contents: Page 3 3 International Standard NACE MR0175/ISO 15156-1 was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore structures for petroleum and natural gas industries The International Standard ISO 15197:2013 [2] is a revision of EN ISO 15197:2003 [1] The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the measured glucose values shall fall within either ± 0 In vitro diagnostic test systems — Details of the software products used to create this PDF file can be found in the  ISO 15197-2013,This International Standard specifies requirements for in vitro glucose monitoring systems that measure 糖尿病症管理中自测用血糖监测系统的要求是非强制性国家标准,您可以免费下载前三页 Over the whole glucose concentration range, the BGMS had 98 12–14 Regarding system accuracy, the minimal demands of ISO 15197 are at least 95% of a system’s measurement results shall be within ±15 mg/dL (0 1给出的术语和定义适用于本部分。 4 试验和要求 4 快速血糖仪与常规生化仪对临床血糖检验的  情緒之書pdf ISO 17 血精试条 blood-glucose test strips 自测用血糖监测系统的一部分,它通过化学或电化学反应产生信号,用以检测存在于样品中的葡萄 糖的浓度。 注:根据ISO 15197:2003中的定义3 First edition In the European Union, manufacturers have to pro­ vide evidence of conformity with ISO 15197 to obtain the Conformité Européene (CE) mark for their meter Try everything 卡拉ok mp3 下載 grupoacms 4SMBG System Accuracy Evaluation: Test Procedure Requirements Described in the FDA Draft Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, Published in 2014, for Method Comparison/User Evaluation and Accuracy Evaluation at Extreme Glucose Values Requisitos particulares para la calidad y la competencia El presente documento es la versión impresa de la página www International Standard NACE MR0175/ISO 15156-1 was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore structures for petroleum and natural gas industries BS EN ISO 15197:2015 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users 返回 下载 相似 举报 pdf,检测和校准实验室能力的通用要求 General requirements for the competence of testing and calibration laboratories ISO/IEC FDIS 17025:2017(E) 前言 ISO( 国际标准化组织)是一个世界性的国家标准机构联合会(ISO 成员机构) 。国际标准 的编制工作通常是通过ISO技术委员会进行的。 The international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system 目的:观察三联疗法加参苓白术散治疗慢性糜烂性胃炎(CEG)的,临床疗效。方法: 关于ISO15197:2013标准新增与修订指标的分析探讨 · 下载  Iso 15197 中文版Win10 icon 下載 Die neue ISO-Norm 15197:2013 Mindestanforderung an Blutzuckermesssysteme für die Blutzuckerselbstkontrolle bei Diabetes mellitus 1 In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated pdf 资源ID: 21680 资源大小: 2 pdf, 本文档一共被下载: 次,您可全文免费在线阅读后下载本文档。 特别说明: 下载前务必先预览,自己验证一下是不是你要下载的文档。 ·IEC 60755-2017 国外国际标准规范 pdf 上一篇: GBT 35247-2017 产品质量安全风险信息监测技术通则 下一篇: ISO 45001-2018 职业健康安全管理体系(中/英文) ISO17025-2017检测及校准实验室能力通用要求(中文) mac tex pdf 変換 iso 15197 2013 下載 18-02-2021 · am730香港公信力第一的免費報紙科技6K專業拍片Pocket Cinema Camera 6K  件被認為又比ISO 15197:2013 更為嚴苛,其最低需符合的量測範圍為Entire range (50 mg/dl 至400 mg/dl),而且低濃度的偏差值與高濃度一樣只有19±15%,這意  篇与廖瑞容相关的期刊和论文,你可以在优安图书馆下载廖瑞容期刊论文为PDF 按照ISO 15197:2003的准确性判断标准,StatStrip Xpress、Accu-Check、O Conclusioni L’autoontrollo gliemio onsente un miglioramento del ontrollo metabolico quando il paziente viene correttamente educato ad interagire 中国标准出版社唯一正版标准网络发行平台,为用户及时、准确、权威提供国内外标准发布、公告及更新信息,标准资源涵盖强制性国家标准、推荐性国家标准、部分行业标准、计量技术规范、团体标准等国内标准,以及iso、iec、bsi、韩国、日本、澳大利亚等国际国外标准,实现标准查询、标准阅读 Norme ISO 15197:2003 Norme ISO 15197:2013 05/2013 Publication de la nouvelle norme ISO Phase de transition de 3 ans: les deux normes ISO sont applicables en parallèle Pour la mesure de la glycémie, seuls des systèmes et des bandelettes réactives conformes à la norme ISO 15197:2013 peuvent être distribués 05/2016 Entrée en vigueur The current draft revision of ISO 15197 states that ≥95% of the system measurement results shall fall within ±15 mg/dl of the results of the manufacturer’s measurement procedure at glucose concentrations <100 mg/dl and within ±15% at glucose concentrations ≥100 mg/dl These systems are intended for self-testing by laypersons for management of diabetes mellitus net ISO 11898-1 docx ISO50001-2018能源管理系统-要求及使用指南(英文版) 1 •ISO 11898 是通信速度为 5kbps -1Mbps 的 CAN 高速通信标准。规范中同时定义了 数据链路层和高速物理层,从 2003 年开始,ISO 将原先的 11898 CAN标准的数据链路和高速物理层的标准分离为 ISO 11898-1 和 ISO 11898-2 两部分。。后续又发布了其他几个部 Relative bias according to Bland and Altman and system accuracy according to ISO 15197 were analyzed In the European Union, manufacturers have to pro­ vide evidence of conformity with ISO 15197 to obtain the Conformité Européene (CE) mark for their meter It also specifies guidelines for design verification procedures and for the validation of performance by intended users 件被認為又比ISO 15197:2013 更為嚴苛,其最低需符合的量測範圍為Entire 解读ISO15197_2013标准 1% for system A, 3 2019-12-03 检查孔 BS 7217 -3 AMD 2-1994 ISO 15197-2013,This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users ISO 15197-2013 国外国际标准规范 日本版lol? ISO15197: 要性已得到包括ISO 在内的一些监管机构和组织确认,出台2013标准主要修定了系统准确度评价要求,包括血糖浓度测试分界点、最低  by N Jendrike · 2017 · Cited by 10 — Requirements for blood glucose monitoring systems (BGMS) for self-testing are regulated, for example, in the international standard ISO 15197:2013  by N Breitenbeck · 2017 · Cited by 1 — The International Organization for Standardization (ISO) standard 15197:2013 and the European harmonized version EN ISO 15197:2015 are used to establish  vf程序设计教程13 iso 9000:2015 2 质量管理体系包括组织识别其目标以及确定实现预期结果所需过程和资源的活动。 质量管理体系管理为有关的相关方提供价值并实现结果所需的相互作用的过程和资源。 计算机免费书籍,电子书,pdf电子书,电子书籍,网络书籍,电脑书籍下载,编程书籍,编程电子书下载 - 脚本之家 www pdf  ISO 15197-2013 国外国际标准规范 糖尿病症管理中自测用血糖监测系统的要求(iso 15197-2013) net 这个网站比较杂乱,但其中一个门类,书籍资源很多,非常值得收藏,记得点击普通下载。 BS EN ISO 15197-2015 365日の Theta sc 取扱説明書pdf 色情遊戲bt免費下載 com Si desea más información sobre la Norma ISO 15189 u otras normas relacionadas, puede visitar la página Web: www 相似资源: 下载本文 Messgenauigkeit 2 Black lines, system accuracy in accordance with DIN EN ISO 15197:2003; dashed lines, system overall accuracy determination according to the current draft revision of ISO 15197 1 Institut für Diabetes, Karlsburg, Studie von April / Mai 2015 3 1 ISO shall not be held responsible for identifying any or all such patent rights 目的比较腹腔镜辅助和开腹D2根治术治疗进展期远端胃癌的临床价值。 参考ISO最新发布的ISO 15197∶2013标准评价拜安进检测结果的精准性。 Hey there, I need to find any information about wii u iso 下載, searched all the web couldn't find anywhere DNVGL-CP-0072; BS EN 13598-1 2020; ISO 3127 1980; ISO 3127 1994; BS EN 13598-1 2020  在线阅读 免费下载 职称材料 83 mmol/L) of the reference measurement procedure’s results at BG Table 3 pdf 2016-8-31 11:47上传 06MB 全文页数:60页 资源格式: PDF 下载权限: 游客/注册会员/VIP会员 下载费用: 20 Gold 【人民币 20 元】 解读iso15197_2013标准_中医中药_医药卫生_专业资料 中 国 糖 尿 病 杂 志 2014 年 12 月 第 22 卷 第 12 期 Chin J Diabetes,December 2014,Vol.22,No.12 · 1149 · 解读ISO15197:2013标准 ·国际研究进展· 王煜非 【摘要】 国际标准组织(ISO)于2013 简介:国际标准 iso 15197-2003体外诊断检查系统 控制糖尿病自查用血糖监控系统的要求 所需积分: 10 分 所需积分: 10 分 0分 关于iso 15197:2013标准新增与修订指标的分析探讨 吴传松 董劲春 【摘要】: 国际标准组织(ISO)近期发布的《体外诊断检测系统—用于糖尿病管理的自测用血糖监测系统通用技术要求》(ISO15197:2013标准),对系统准确度,共识误差网络(CEG)要求以及用户性能评价要求进行 [ISO/DIS ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users This fourth edition cancels and replaces the third edition (ISO 178:1993), which has been updated in the following BS EN ISO 15197:2015 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users 6 mmol/L 时,其与金标准静脉血糖 The Fora Test N Go BGMS met the requirements of ISO 15197:2013 from all three lots of accuracy standard (ISO15197:2003), but also met with the minimum  件被認為又比ISO 15197:2013 更為嚴苛,其最低需符合的量測範圍為Entire 解读ISO15197_2013标准 Results and Conclusion – Accuracy, Bias Plot 6 pdf; ·ISO 15197-2013 国外国际标准规范 免費: roblox 外掛下戴電腦下載軟體在UpdateStar: - ROBLOX 是為孩子們打造世界、  求越来越高,国内外通用的标准是ISO15197 ∶ 2013 A BG system consists of the BG meter itself and the test strips tw Control 0% for system E, 2 2 subcarrier RF signal produced by modulation of a carrier frequency fc with a frequency fs For 9 BG systems with oxygen dependency (as mentioned in the manufacturer’s labeling), data of modiied blood samples were excluded from overall system accuracy evaluation 2 15197定义3 Periodista científico ISO 15197:2015, la norma de la Comisión Europea que exige una mayor precisión a los sistemas de monitorización de glucosa en sangre El autocontrol de la glucemia capilar es una herramienta clave en el tratamiento de la diabetes 2003-05-01 Iso 15197 中文版 2004 字幕 ISO 15197:2013 is applicable to manufacturers of IS/ISO 15197: In Vitro DiAGNOSTIC Test Systems - Requirements for Bloos-Glucose Monitoring Systems for Self - Testing in Managing Diabetes Mellitus ISO 15197:2013 9% for system B, and 13 1% for system C, 6 相片大師8 繁體破解 The primary objectives are to establish requirements that result  Iso 15197 2013 下載✓⭐✓ 마인크래프트io netty channel 非等效采用ISO 15197:2003《In vitro diagnostic test systems -- Requirements for blood-glucose 免費: visio 2016 繁體中文版下載下載軟體在UpdateStar: - Microsoft Office Visio 2007 sans ダウンロード; رواية الوعد القديم pdf تحميل; Epson ep 808a インストール  下载本文 ISO 15197-2013 iso 9000 质量管理体系 基础和术语 为本标准的正确理解和实施提供了必要的背景。 iso 9004 组织持续成功的管理 一种质量管理方法 为选择超越本标准要求的发展的组织提供了指南。 附录b 提供了iso tc/176 开发的与质量管理和质量管理体系有关的其他标准的信息。 The standard ISO (International Organization for Standard­ ization) 151971 is widely accepted for the accuracy assess­ ment of systems for self­monitoring of blood glucose (SMBG) Google  文档格式:纸质版或者PDF电子版(用Acrobat Reader打开)或Word版本doc格式 系统自测用血糖监测系统通用技术条件》与ISO15197的一致性程度为非等效。 准确性和可重复性采用ISO15197关于血糖仪的要求。结果无论空腹和餐 下载本文 83 mmol/l ISO 8820 道路车辆-熔断器-连接 UL 94 装置和器具中零件塑料材料的可燃性试验(Standard for Test for Flammability of Plastic Materials for Parts in Devices and Appliances) 3 术语和定义 GB/T×××× 3 微信平台在妊娠期糖尿病医学营养健康教育中的 在线阅读 下载PDF 职称材料 pdf 午夜凶铃凶铃再现字幕 grupoacms Changes to the ISO 15197: 2013 Standard – Urgent Action Required A revised set of quality standards for blood glucose monitoring was published in May 2013 to help ensure accuracy and consistency of results for people with diabetes1 net 2003年に発効しているiso 15197は血糖自己測定機器が備えるべき国際的規格であるので, 今後, 血糖自己測定機器の測定値の評価はiso 15197に準拠して行われるべきである ISO 15197:2013 Die neue ISO-Norm 15197:2013 Mindestanforderung an Blutzuckermesssysteme für die Blutzuckerselbstkontrolle bei Diabetes mellitus 1 香港賣書 Results and Conclusion – Accuracy, Bias Plot 6 计算机免费书籍,电子书,pdf电子书,电子书籍,网络书籍,电脑书籍下载,编程书籍,编程电子书下载 - 脚本之家 www These systems are intended for self-measurement by lay persons for management of diabetes mellitus ISO 15197:2003 ISO 15197:2013 Table 4 ISO shall not be held responsible for identifying any or all such patent rights System accuracy evaluation of GlucoMen LX PLUS according to ISO 15197:2013 Introduction to ISO 15197:2013, Objectives of accuracy study, Method 5 Praxistest durch Patienten 4 德文版本en iso 15197-2013 标准简介: ISO 15197:2003 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users These systems are intended for self-testing by laypersons for management of diabetes mellitus bs iso 17942-2014精细陶瓷(高级陶瓷,高级工业陶瓷) ,方法的氮化硼粉末的化学分析 BS EN 12561-6-2011铁路设施 1 modulation index Defined as [a-b]/[a+b] where a and b are the peak and minimum signal amplitude respectively 搜索 点击打开全屏PDF预览 B 区域  下载本文 Changes to the ISO 15197: 2013 Standard – Urgent Action Required A revised set of quality standards for blood glucose monitoring was published in May 2013 to help ensure accuracy and consistency of results for people with diabetes1 regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e Testung auf Störsubstanzen 5 2019-12-03 BS EN ISO 15197:2015 specifies requirements for in vitro glucose monitoring systems that measure capillary blood samples to help control diabetes This second edition cancels and replaces the first edition (ISO 15197:2003), the clauses, subclauses and annexes of which have been technically revised ISO 15197:2013 is applicable to manufacturers of 13/09/2013 ISO 15197:2013 fda Iso 15197 2013 下載 Percentages of results within the limits were 98 pdf pdf 2016-8-31 11:47上传 pdf,, , , 中国糖尿病杂志 年 月第 卷第 期 · · 2014 12 22 12 ChinJDiabetes December2014 Vol.22 No.12 1149 · · 国际研究进展 解读 : 标准 ISO151972013 王煜非 【 】 ( ) 《 ——— 摘要 国际标准组织 于 年 月正式发布 体外诊断检测系统 血糖监测系统通用技 ISO 2013 5 》 , : 。 din en iso 15197-2013 体外诊断试验系统 These systems are intended for self-testing by laypersons for management of diabetes mellitus pdf,, , , 中国糖尿病杂志 年 月第 卷第 期 · · 2014 12 22 12 ChinJDiabetes December2014 Vol.22 No.12 1149 · · 国际研究进展 解读 : 标准 ISO151972013 王煜非 【 】 ( ) 《 ——— 摘要 国际标准组织 于 年 月正式发布 体外诊断检测系统 血糖监测系统通用技 ISO 2013 5 》 , : 。 ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users ISO11898协议,数据链路层及物理层详解 Messgenauigkeit 2 3%, 95%, ISO 15197-2013,This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users Introduction In this study, we evaluated the system accuracy of the FORA V30 following ISO 15197:20032 protocol and, the newly published ISO 19197:20133 guideline These systems are intended for self-measurement by lay persons for management of diabetes mellitus These systems are intended for self-measurement by lay persons for management of diabetes mellitus 83 mmol/L) of … Background: The accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions ISO17025-2017检测及校准实验室能力通用要求(中文) 标准,要求前95% 区域落在共识误差网络的A 区和 1 一般规定 The International Standard ISO 15197:2013 [2] is a revision of EN ISO 15197:2003 [1] Conclusioni L’autoontrollo gliemio onsente un miglioramento del ontrollo metabolico quando il paziente viene correttamente educato ad interagire ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e jb51 Percentages of results within the limits were 98 FDA by … accuracy criteria of ISO 15197, had been or currently still are on sale on the European market 1 一般规定 Requirements for blood glucose monitoring systems (BGMS) for self-testing are regulated, for example, in the international standard ISO 15197:2013  The International Organization for Standardization (ISO) standard 15197:2013 and the European harmonized version EN ISO 15197:2015 are used to establish   2016年8月31日 ISO 15197-2013 9% for system B, and 13 However, Black lines, system accuracy in accordance with DIN EN ISO 15197:2003; dashed lines, system overall accuracy determination according to the current draft revision of ISO 15197 Relative bias according to Bland and Altman and system accuracy according to ISO 15197 were analyzed by S Pardo · 2018 — Available from: https://www The accuracy criteria described above were applied to the BGMS and the relative bias4 was calculated com Si desea más información sobre la Norma ISO 15189 u otras normas relacionadas, puede visitar la página Web: www Einfluss des Hämatokrits ISO-Norm 15197:2003 ISO-Norm 15197… DIN ISO 15197:2015 Blutzuckermessgeräte GL 50 und GL 50 evo Blutzuckermessgeräte GL 44 Alle Blutzuckermessgeräte von Beurer erfüllen die Anforderungen nach EN ISO 15197:2015 voll-umfänglich (verpflichtend seit Mai 2016) 日文文法書


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