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医疗设备(体外诊断)检测

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军工检测 其他检测

NF S92-033*NF EN 13975:2003 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.

UNE-EN 12322:1999 微生物学培养基 文化媒的性能标准

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

KS P ISO 18113-4-2015(2020 - 制造商提供的信息(标签) - 第4部分: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 19001:2013 .生物着色用实验室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 18113-2:2018 - 制造商提供的信息(标签) - 第2部分:专业使用的试剂

In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use

KS P ISO 18113-5-2015(2020 - 制造商提供的信息(标签) - 第5部分:用于自检的仪器

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

BS EN 12286:1999(2001 .生物有机试样数量测量.参考测量过程说明

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

BS EN 12286:1999 .生物有机试样数量测量.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

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

MEDDEV 2.14/3-2007 指导方针.有关的指导方针:使用说明书(IFU)和其他(IVD)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

BS EN 14254:2004 .取自于人的不包括血液的样品用一次性容器

This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

BS EN 12287:1999 .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

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

ISO/IEEE 11073-10408:2010 保健信息学.床边(POC)通信.第10408部分:规范.温计

IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or environmental protection in all circumstances. Implementers

Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer

NF S97-518-10415*NF EN ISO 11073-10415:2011 保健信息学.床边(POC)通信.第10415部分:规范.磅秤

Health informatics - Personal health device communication - Part 10415 : device specialization - Weighing scale.

ISO/IEEE 11073-10415:2010 保健信息学.床边(POC)通信.第10415部分:规范.磅秤

IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or environmental protection in all circumstances. Implementers

Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale

ISO/IEEE 11073-10417:2010 保健信息学.床边(POC)通信.第10415部分:规范.血糖仪

IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection in all circumstances. Implementers

Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter

NF S92-033*NF EN 13975:2003 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.

UNE-EN 12322:1999 微生物学培养基 文化媒的性能标准

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

KS P ISO 18113-4-2015(2020 - 制造商提供的信息(标签) - 第4部分: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 19001:2013 .生物着色用实验室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 18113-2:2018 - 制造商提供的信息(标签) - 第2部分:专业使用的试剂

In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use

KS P ISO 18113-5-2015(2020 - 制造商提供的信息(标签) - 第5部分:用于自检的仪器

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

BS EN 12286:1999(2001 .生物有机试样数量测量.参考测量过程说明

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

BS EN 12286:1999 .生物有机试样数量测量.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

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

MEDDEV 2.14/3-2007 指导方针.有关的指导方针:使用说明书(IFU)和其他(IVD)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

BS EN 14254:2004 .取自于人的不包括血液的样品用一次性容器

This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

BS EN 12287:1999 .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

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

ISO/IEEE 11073-10408:2010 保健信息学.床边(POC)通信.第10408部分:规范.温计

IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or environmental protection in all circumstances. Implementers

Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer

NF S97-518-10415*NF EN ISO 11073-10415:2011 保健信息学.床边(POC)通信.第10415部分:规范.磅秤

Health informatics - Personal health device communication - Part 10415 : device specialization - Weighing scale.

ISO/IEEE 11073-10415:2010 保健信息学.床边(POC)通信.第10415部分:规范.磅秤

IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or environmental protection in all circumstances. Implementers

Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale

ISO/IEEE 11073-10417:2010 保健信息学.床边(POC)通信.第10415部分:规范.血糖仪

IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection in all circumstances. Implementers

Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter

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