体外诊断设备检测

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

COM(95)/C 172/02-1995 针对关于体外诊断设备的欧洲议会和欧盟理事会指令的提案

Proposal for a European Parliament and Council Directive on in Vitro Diagnostic Medical Devices

ISO 20916:2019 使用人类标本的体外诊断设备（IVD）的临床表现研究 - 良好的学习实践

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

DS/INF 174:2013 医疗设备公共采购建议，包括辅助设备、体外诊断设备和植入物 采购流程、要求规范、评估标准和合同条件

Recommendations for the public procurement of medical equipment, including assistive devices, in vitro diagnostic devices and implants - Procurement process, requirements specification, assessment criteria and contract conditions

COM(96) 643 FINAL-1996 针对对体外诊断设备的指令的提案进行修改的欧洲议会和欧盟理事会条例的提案

Amended Proposal for a European Parliament and Council Directive Amending the Directive Proposal on in Vitro Diagnostic Medical Devices

DIN EN 592:2002 个人用体外诊断检查设备使用说明

Instructions for use for devices for in-vitro diagnostic examinations for personal use

MEDDEV 2.14/3-2007 医疗设备指导方针.有关体外诊断设备的指导方针:使用说明书(IFU)和其他体外诊断(IVD)医疗设备信息的提供.适用于制造商和公告机构的指导方针.修订件1

GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

MEDDEV 2.14/1-2004 医疗设备指导方针.有关体外诊断设备的指导方针:界定方面的问题.适用于制造商和公告机构的指导方针.修订件1

GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES Rev. 1

BS ISO 21474-2:2022 体外诊断医疗设备 核酸多重分子检测 验证和验证

1   Scope This document gives the general requirements for validation and verification of multiplex molecular tests which simultaneously

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification

NF S92-033*NF EN 13975:2003 体外诊断医疗设备的验收试验用取样程序.统计问题

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

NP EN 12286-2000 体外诊断测量设备．大量生物样品测量，相关的测量参考

A presente Norma Europeia específica as exigências relativas à redac??o de um procedimento de medi??o de referência. NOTA: Tem a finalidade de

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

UNE-EN 12322:1999 体外诊断医疗设备 微生物学培养基 文化媒体的性能标准

IN VITRO DIAGNOSTIC MEDICAL DEVICES. CULTURE MEDIA FOR MICROBIOLOGY. PERFORMANCE CRITERIA FOR CULTURE MEDIA.

2009/886/EC CORR-2009 2009年11月27日欧盟委员会对有关体外诊断设备的通用技术规范的 2002/364/EC号决定进行修订的决定的勘误表.2009年12月4日欧盟官方公报L 318[:EU 2002/364/EC]

Corrigendum to Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices

BS EN ISO 19001:2013 体外诊断医疗设备.生物着色用实验室诊断试剂生产厂商提供的信息

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

KS P ISO 18113-4-2015(2020 体外诊断医疗设备 - 制造商提供的信息（标签） - 第4部分:体外诊断试剂用于自检

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

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

COM(95)/C 172/02-1995 针对关于体外诊断设备的欧洲议会和欧盟理事会指令的提案

Proposal for a European Parliament and Council Directive on in Vitro Diagnostic Medical Devices

ISO 20916:2019 使用人类标本的体外诊断设备（IVD）的临床表现研究 - 良好的学习实践

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

DS/INF 174:2013 医疗设备公共采购建议，包括辅助设备、体外诊断设备和植入物 采购流程、要求规范、评估标准和合同条件

Recommendations for the public procurement of medical equipment, including assistive devices, in vitro diagnostic devices and implants - Procurement process, requirements specification, assessment criteria and contract conditions

COM(96) 643 FINAL-1996 针对对体外诊断设备的指令的提案进行修改的欧洲议会和欧盟理事会条例的提案

Amended Proposal for a European Parliament and Council Directive Amending the Directive Proposal on in Vitro Diagnostic Medical Devices

DIN EN 592:2002 个人用体外诊断检查设备使用说明

Instructions for use for devices for in-vitro diagnostic examinations for personal use

MEDDEV 2.14/3-2007 医疗设备指导方针.有关体外诊断设备的指导方针:使用说明书(IFU)和其他体外诊断(IVD)医疗设备信息的提供.适用于制造商和公告机构的指导方针.修订件1

GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

MEDDEV 2.14/1-2004 医疗设备指导方针.有关体外诊断设备的指导方针:界定方面的问题.适用于制造商和公告机构的指导方针.修订件1

GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES Rev. 1

BS ISO 21474-2:2022 体外诊断医疗设备 核酸多重分子检测 验证和验证

1   Scope This document gives the general requirements for validation and verification of multiplex molecular tests which simultaneously

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification

NF S92-033*NF EN 13975:2003 体外诊断医疗设备的验收试验用取样程序.统计问题

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

NP EN 12286-2000 体外诊断测量设备．大量生物样品测量，相关的测量参考

A presente Norma Europeia específica as exigências relativas à redac??o de um procedimento de medi??o de referência. NOTA: Tem a finalidade de

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

UNE-EN 12322:1999 体外诊断医疗设备 微生物学培养基 文化媒体的性能标准

IN VITRO DIAGNOSTIC MEDICAL DEVICES. CULTURE MEDIA FOR MICROBIOLOGY. PERFORMANCE CRITERIA FOR CULTURE MEDIA.

2009/886/EC CORR-2009 2009年11月27日欧盟委员会对有关体外诊断设备的通用技术规范的 2002/364/EC号决定进行修订的决定的勘误表.2009年12月4日欧盟官方公报L 318[:EU 2002/364/EC]

Corrigendum to Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices

BS EN ISO 19001:2013 体外诊断医疗设备.生物着色用实验室诊断试剂生产厂商提供的信息

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

KS P ISO 18113-4-2015(2020 体外诊断医疗设备 - 制造商提供的信息（标签） - 第4部分:体外诊断试剂用于自检

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