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现行 KS P ISO 19001-2017(2022)
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체외진단용 의료기기 — 생물학에서 염색을 위한 체외진단 시약에 대하여 제조자가 제공하여야 할 정보 体内诊断医疗器械.生物学染色用体外诊断试剂制造商提供的信息
发布日期: 2017-12-29
该标准规定了制造者提供的信息的要求,以及生物学中用于染色的试剂。该标准适用于生物学中用于染色的染料、染色液、显色试剂以及其他试剂的生产者、供应商和销售者。对该标准规定的制造者提供的信息的要求是获得生物学中染色全领域可比较和可再现结果的前提。
이 표준은 생물학에서 염색에 사용되는 시약과 함께 제조자가 제공하는 정보에 대한 요구사항을 규정한다. 이 표준은 생물학에서 염색에 사용하는 염료, 염색액, 발색시약 및 그 외의 다른 시약의 생산자, 공급자 및 판매자에게 적용한다. 이 표준에 규정된 제조자가 제공하는 정보에 대한 요구사항은 생물학에서 염색 전 분야에 걸쳐 비교 가능하고 재현 가능한 결과를 얻기 위한 전제 조건이다.
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发布单位或类别: 韩国-韩国标准
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