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现行 KS P ISO 18113-1-2018
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체외진단 의료기기 — 제조자가 제공하는 정보(라벨링) — 제1부: 어휘 및 일반 요구사항 体外诊断医疗器械 - 制造商提供的信息(标签)第1部分:术语 定义和一般要求
发布日期: 2018-08-22
KS P ISO 18113的该部定义了体外诊断医疗器械制造者提供的信息的概念,树立了一般原则,规定了核心要求。KS P ISO 18113的这部分不涉及术语的要求,因为这部分是法律和规定中要涉及的领域。KS P ISO 18113的本部对以下事项不适用:a)用于性能评价的体外诊断医疗器械(例如,研究专门用途)b)仪器显示c)物质安全保健资料
KS P ISO 18113의 이 부는 체외 진단 의료기기 제조자가 제공하는 정보에 대한 개념을 정의하고, 일반 원칙을 수립하며, 핵심 요구사항을 규정한다. KS P ISO 18113의 이 부는 용어에 대한 요구사항을 다루지 않는데, 이 부분은 법률 및 규정에서 다루어야 할 영역이기 때문이다.KS P ISO 18113의 이 부는 다음 사항에 대해서는 적용하지 않는다.a) 성능 평가용 체외 진단 의료기기(예를 들면, 연구 전문 용도)b) 기기 표시c) 물질 안전 보건 자료
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发布单位或类别: 韩国-韩国标准
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