11.100.10 标准查询与下载

DIN EN 61010-2-101:2003 测量、控制和实验室用电气设备的安全要求.第2-101部分:体外诊断(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 (IEC 61010-2-101:2002, modified); German version EN 61010-2-101:2002

ISO 17511:2003 体外诊断医疗装置.生物试样的定量测量.校准仪和控制材料赋值的计量溯源性

水标准规定厂对以建立或确认测量正确度为日的的校准品和控制物质赋值的计量学溯源性进{；确 认的方法。校准品和控制物质山制造商提供，作为体外诊断医疗器械的—·部分或与其—起使用， 由国际公认的参考测量系统或国际公认的约定参考测量系统赋值的、已证实具有丌—换性的室间质 量评价样品适用于本标准。 本标准不适用于： a) 没有赋值及只用于评价·个测量程序的精密度，即其重复性或重现忭的控制物质(精密度控制 物质)； b) 用于实验室内质量控制的控制物质，此类物质具有建议的可接受结果值区间，此区间不用 实验室针对具体测量程序协议制定，其限值无计量学溯源性； c） 在相同的计量水平下，测量相同量的两个测量程序的测量结果具相关性，但是这样的”水平”相 关不提供汁母斗：溯源性； d) 以不同计量水平的两个测量程序结果问的相关作校准，但是测量的分析物特性不同； e) 常规结果可溯源至产品校准品的计量溯源忭及其与医学判断限位的关系； f) 与名义标度有关的特性，即无量级的特性(例如血细胞分类)。

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

ISO 18153:2003 体外诊断医疗装置.生物样品的定量测量.校准仪和控制材料所赋酶的催化浓度值的计量溯源性

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 specitied 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

EN ISO 15197:2003 体外诊断试验系统.糖尿病人自测用血糖检测系统要求 ISO 15197-2003

This International Standard specifies requirements for仍vitro glucose monitoring systems that measureglucose concentrations in capillary blood samples and procedures forThe verification andThe validation ofperformance byThe intended users. These systems are intended for self-testing by laypersons formanagement of diabetes mellitus.

In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003

IEC TR 61010-3-101:2003 测量、控制及实验室用电气设备的安全要求.第3-101部分:IEC 61010-2-101:2002的一致性鉴定报告.实验室条件下诊断医疗设备的特殊要求

This report is a Technical Report and is of a purely informative nature and is therefore by itself not to be regarded as an International Standard. It is to assist users of the standard with determining and recording verification of conformity of the equ

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-101: Conformity verification report for IEC 61010-2-101:2002; Particular requirements for in vitro diagnostic (IVD) medical equipment

BS EN 13975:2003 体外诊断用医疗装置的验收试验用取样规程.统计特性

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.

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

EN 13975:2003 体外诊断用医疗装置的验收试验用取样规程.统计特性

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body.

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

NF C42-739:2003 测量、控制和试验室用电气设备的安全要求.第2-101部分:试验室诊断(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.

BS EN 61010-2-101:2002 测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求

Replacement: This part 2 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following:  a physiological or pathological state; or  a congenital abnormality;  the determination of safety and compatibility with potential recipients;  the monitoring of therapeutic measures. Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a home environment. NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 as well as within the scope of this standard, it will also need to meet the requirements of those other part 2 standards.

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

ISO 15194:2002 实验室条件下医用诊断装置.生物原始试样中数量值的测量.标准物质的描述

This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement pro-cedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This European Standard also provides instructions on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate. This European Standard is not applicable to the production of the reference materials.

In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials

ISO 15193:2002 实验室条件下医用诊断装置.生物原始试样中数量值的测量.参考测量法的说明

This European Standard specifies requirements for the drafting of a reference measurement procedure. NOTE: It is intended that an experienced laboratory worker, following a measurement procedure written in accordance with this European Standard can be expected to produce results with an uncertainty of measure-ment not exceeding the stipulated range. This European Standard is applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

DIN EN 13641:2002 体外诊断试剂相关的感染风险的消除或降低; 德文版本 EN 13641:2002、德文和英文文本

This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits.

Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts

NF S92-032:2002 体外诊断试剂的稳定性试验

Stability testing of in vitro diagnostic reagents.

EN 13641:2002 消除和降低与在实验室条件下诊断试剂相关感染性风险

This European Standard specifies requirements related to design and manufacture in order to effectively controlthe risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materialsand kits, hereinafter called IVD reagents.The standard is applicable to in vitro diagnostic reagents containingmaterial of human origin.The standard is also applicable to in vitro diagnostic reagents containing materialsobtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, whenthe results of a risk analysis reveal thatThere is a risk of human infection.The standard does not apply toThe following:一instruments and specimen receptacles;NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment isaddressed in other relevant International and/or European Standards.一general aspects of workers' protection;transportation of infectious goods;一disposal measures.NOTE 2 Some of the most relevant documents relating to aspects not covered byThis standardBibliography for information.are listed in

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

BS EN 13641:2002 消除和降低与体外诊断试剂有关的感染的危险性

This European Standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection. The standard does not apply to the following: - instruments and specimen receptacles; NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards. - general aspects of workers' protection; - transportation of infectious goods; - disposal measures. NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

BS EN 13532:2002 自测试用的体外诊断医疗装置的一般要求

This European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.

General requirements for in vitro diagnostic medical devices for self-testing

BS EN 13612:2002 体外诊断医疗装置的性能评估

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.

Performance evaluation of in vitro diagnostic medical devices

BS EN 376:2002 制造商提供的有关自我测试用的体外诊断试剂的信息

This European Standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents. NOTE This standard can also be applied to accessories.

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

BS EN 592:2002 自我测试用体外诊断仪器的使用说明书

This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions.

Instructions for use for in vitro diagnostic instruments for self-testing

BS EN 13640:2002 体外诊断试剂的稳定性试验

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the - determination of IVD reagent shelf-life including transport stability; - determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability); - monitoring of stability of IVD reagents already placed on the market; - verification of stability after IVD reagent modifications that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.

Stability testing of in vitro diagnostic reagents