自我检测用体外诊断医疗器械基本要求检测

YY/T 1454-2016 自我检测用体外诊断医疗器械基本要求

本标准规定了自我检测（以下简称自测）用体外诊断医疗器械的设计原则、制造商提供的标记和信息、性能评估、用户验证等。本标准适用于自我检测用体外诊断医疗器械。本标准不适用于自测用体外诊断医疗器械的医学特性

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

GOST R EN 13532-2010 体外诊断医疗器械自检通用要求

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

UNE-EN 13532:2002 用于自检的体外诊断医疗器械通用要求

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

CEN EN 13532-2002 用于自检的体外诊断医疗器械的一般要求

General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing

NF S92-024*NF EN 13532:2002 自测用体外诊断医疗器材的一般要求

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

YY/T 1441-2016 体外诊断医疗器械性能评估通用要求

本标准适用于对体外诊断医疗器械(以下简称IVD MD)的性能评估，包括自我检测体外诊断医疗器械，进行性能评估。 本标准规定了制造商在性能评估研究中对研究计划、实施、评估和制定文件的职责和总体要求。 本标准不适用于对某一特定IVD MD或某一具体用途的评估方案。 考虑到IVD MD的性质和用途

General requirements of performance evaluation of in vitro diagnostic medical devices

DIN EN 13532:2002 体外诊断医疗器械自检通用要求；德文版 EN 13532:2002，德文和英文文本

General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts

EN ISO 18113-4:2009 体外诊断医疗器械.制造商提供的信息(标签).第4部分:体外诊断试剂进行自我测试

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

EN ISO 18113-4:2011 体外诊断医疗器械.制造商提供的信息(标签).第4部分:体外诊断试剂进行自我测试

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

BS EN ISO 18113-4:2011 体外诊断医疗器械.制造商提供的信息(标签).自测用体外诊断剂

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

GB/T 29791.5-2013 体外诊断医疗器械 制造商提供的信息（标示） 第5部分:自测用体外诊断仪器

GB/T 29791的本部分规定了自测用体外诊断(IVD)仪器制造商提供信息的要求。本部分也适用于预期与自测用体外诊断医疗仪器一起使用的装置和设备。本部分也适用于IVD附件。本部分不适用于:a)仪器维修或修理的说明;b)体外诊断试剂,包括校准物和用于控制该试剂的控制物质;c)专业用体外诊断仪器

In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting

EN ISO 18113-5:2011 体外诊断医疗器械.制造商提供的信息(标签).第5部分:体外诊断仪器自检

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

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

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

NF S92-011:1992 活体外诊断系统.自我试验用活体外诊断剂加标签要求

IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).

BS EN ISO 18113-5:2011 体外诊断医疗器械.制造商提供的信息(标签).自试验用体外诊断仪器

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing

YY/T 1454-2016 自我检测用体外诊断医疗器械基本要求

本标准规定了自我检测（以下简称自测）用体外诊断医疗器械的设计原则、制造商提供的标记和信息、性能评估、用户验证等。本标准适用于自我检测用体外诊断医疗器械。本标准不适用于自测用体外诊断医疗器械的医学特性

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

GOST R EN 13532-2010 体外诊断医疗器械自检通用要求

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

UNE-EN 13532:2002 用于自检的体外诊断医疗器械通用要求

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

CEN EN 13532-2002 用于自检的体外诊断医疗器械的一般要求

General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing

NF S92-024*NF EN 13532:2002 自测用体外诊断医疗器材的一般要求

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

YY/T 1441-2016 体外诊断医疗器械性能评估通用要求

本标准适用于对体外诊断医疗器械(以下简称IVD MD)的性能评估，包括自我检测体外诊断医疗器械，进行性能评估。 本标准规定了制造商在性能评估研究中对研究计划、实施、评估和制定文件的职责和总体要求。 本标准不适用于对某一特定IVD MD或某一具体用途的评估方案。 考虑到IVD MD的性质和用途

General requirements of performance evaluation of in vitro diagnostic medical devices

DIN EN 13532:2002 体外诊断医疗器械自检通用要求；德文版 EN 13532:2002，德文和英文文本

General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts

EN ISO 18113-4:2009 体外诊断医疗器械.制造商提供的信息(标签).第4部分:体外诊断试剂进行自我测试

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

EN ISO 18113-4:2011 体外诊断医疗器械.制造商提供的信息(标签).第4部分:体外诊断试剂进行自我测试

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

BS EN ISO 18113-4:2011 体外诊断医疗器械.制造商提供的信息(标签).自测用体外诊断剂

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

GB/T 29791.5-2013 体外诊断医疗器械 制造商提供的信息（标示） 第5部分:自测用体外诊断仪器

GB/T 29791的本部分规定了自测用体外诊断(IVD)仪器制造商提供信息的要求。本部分也适用于预期与自测用体外诊断医疗仪器一起使用的装置和设备。本部分也适用于IVD附件。本部分不适用于:a)仪器维修或修理的说明;b)体外诊断试剂,包括校准物和用于控制该试剂的控制物质;c)专业用体外诊断仪器

In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting

EN ISO 18113-5:2011 体外诊断医疗器械.制造商提供的信息(标签).第5部分:体外诊断仪器自检

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

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

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

NF S92-011:1992 活体外诊断系统.自我试验用活体外诊断剂加标签要求

IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).

BS EN ISO 18113-5:2011 体外诊断医疗器械.制造商提供的信息(标签).自试验用体外诊断仪器

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing