11.100.10 标准查询与下载

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 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 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 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

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

EN 13532:2002 自测试用在玻璃试管内诊断的医疗装置一般要求

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 forThe purposes as specified byThe manufacturer.

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

EN 13612:2002 在实验室条件下诊断医疗装置的性能评估.合并勘误表-2002年12月

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 9

Performance evaluation of in vitro diagnostic medical devices

IEC 61010-2-101:2002 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

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. 2 Equipment excluded from scope Addition: Add the following second paragraph: Products for general laboratory use are not IVD medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

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 591:2001 专业用体外诊断仪器的使用说明

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments. 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 professional use

BS EN 12287:1999 体外诊断医疗设备.生物起始试样中的数量测量.标准物质的说明

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 procedures. 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 medical devices - Measurement of quantities in samples of biological origin - Description of reference materials

BS EN 12286:1999 体外诊断医疗设备.生物有机体试样数量测量.参考测量过程说明

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 measurement 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

NF S92-040:1999 活体外诊断医疗装置.生物染色体外诊断试剂制造商提供的信息

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.

NF S92-019:1999 活体外医疗装置.生物起源的样品数量测量.参考测量过程展示(欧洲标准EN 12286)

In vitro medical devices. Measurements of quantities in samples of biological origin. Presentation of reference measurement procedures.

BS EN 1658:1997 对体外诊断仪器作标记的要求

This standard provides requirements for the marking of in vitro diagnostic instruments. In connection with electrical equipment for laboratory use the requirements are additional to those specified in 5.1 to 5.3 of EN 61010-1:1993. An easy to understand uniform marking of in vitro diagnostic instruments is important for their safe and correct handling.

Requirements for marking of in vitro diagnostic instruments

NF S92-018:1997 试管诊断仪器的标记要求

Requirements for marking of in vitro diagnostic instruments.

NF S92-031:1996 体外诊断系统.体外诊断医疗器材用 EN 29001、EN 46001、EN 29002 和 EN 46002 的应用指南

In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices.

DIN 58937-7:1994 普通化验室医学(临床病理学).第7部分:实验室诊断系统的特性列表

General laboratory medicine (clinical pathology); part 7: listing of features of in vitro diagnostic systems

prEN ISO 15193 体外诊断医疗器械 参考测量程序的要求 (ISO/DIS 15193:2023)

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

prEN ISO 5649 医学实验室 实验室开发测试的设计、开发、实施和使用的概念和规范（ISO/DIS 5649:2023）

The proposed standard document specifies requirements for ensuring quality, safety and performance of laboratory-developed tests (LDT). It outlines the general principles and assessment criteria by which LDT shall be designed, developed, manufactured, validated and monitored for internal use by medical laboratories. While the proposed standard follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within certain disciplines of medical laboratory testing. This document does not cover requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-in-vitro-diagnostic purposes. However, the concepts presented in this document may also be useful for these institutions. The proposed standard does not apply to the design, development and industrial production of commercially used in vitro diagnostic medical devices.

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023)