In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 5:In vitro diagnostic instruments for selftesting
IDT ISO 18113-5:2009
全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
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。
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