11.100.10 标准查询与下载

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

FprEN ISO 18113-2 体外诊断医疗器械 制造商提供的信息（标签） 第2部分：专业用体外诊断试剂（ISO/FDIS 18113-2:2022）

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for self-testing.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)

FprEN ISO 18113-4 体外诊断医疗器械 制造商提供的信息（标签） 第4部分：用于自检的体外诊断试剂（ISO/FDIS 18113-4:2022）

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)

FprEN ISO 18113-5 体外诊断医疗器械 制造商提供的信息（标签） 第5部分：用于自检的体外诊断仪器（ISO/FDIS 18113-5:2022）

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)

FprEN ISO 18113-3 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（ISO/FDIS 18113-3:2022）

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for self-testing.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)

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)

FprEN ISO 20916 体外诊断医疗器械 使用人体样本的临床性能研究 良好研究规范（ISO 20916:2019）

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

FprEN ISO 18113-1 体外诊断医疗器械 制造商提供的信息（标签） 第1部分：术语、定义和一般要求（ISO/FDIS 18113-1:2022）

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations. This document does not apply to: a) IVD medical devices for performance evaluation (e.g. for investigational use only); b) shipping documents; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements). .

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)