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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
General requirements for in vitro diagnostic medical devices for self-testing
General requirements for in vitro diagnostic medical devices for self-testing.
General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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)
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
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
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)
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
GB/T 29791的本部分规定了自测用体外诊断(IVD)试剂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器械一起使用的校准物、控制物质制造商提供的信息。本部分也适用于IVD附件。本部分适用于外包装和内包装标签以及使用说明。本部分不适用于:a)体外诊断仪器或设备;b)专业用体外诊断
In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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
General requirements for in vitro diagnostic medical devices for self-testing
General requirements for in vitro diagnostic medical devices for self-testing.
General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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)
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
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
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)
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
GB/T 29791的本部分规定了自测用体外诊断(IVD)试剂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器械一起使用的校准物、控制物质制造商提供的信息。本部分也适用于IVD附件。本部分适用于外包装和内包装标签以及使用说明。本部分不适用于:a)体外诊断仪器或设备;b)专业用体外诊断
In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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