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现行 KS P ISO 15223-2-2019
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의료기기 — 의료기기의 라벨, 라벨링 및제공해야 할 정보에 사용하는 기호 — 제2부: 기호 개발, 선택 및 검증 医疗器械 - 符合医疗器械标签 标签和要提供的信息 - 第2部分:符号开发 选择和验证
发布日期: 2019-11-25
KS P ISO 15223-2的本部规定了ISO 15223-1中要包含的符号的开发、选择和验证过程。该标准的目的是使ISO 15223-1的符号易于理解。如果遵循该标准的符号验证过程得到遵守,则按照ISO14971及IEC62366中定义的那样,只要医疗器械符号使用性相关的残余风险没有客观反对的证据,就视为允许。该标准不限于限制要求或标签的限制方针中规定的符号。
KS P ISO 15223-2의 이번 부는 ISO 15223-1에 포함시킬 기호의 개발, 선택 및 검증 프로세스를 규정한다. 이 표준의 목적은 ISO 15223-1의 기호를 쉽게 이해할 수 있도록 하는 것이다. 이 표준에 따른 기호의 검증 프로세스가 준수되었다면 ISO 14971 및 IEC 62366에 정의된 대로 의료기기 기호의 사용성과 관련된 잔여위험이 객관적인 반대의 증거가 있지 않는 한 허용되는 것으로 간주한다. 이 표준은 규제 요구사항 또는 라벨링의 규제 지침에 규정된 기호에만 한정되지 않는다.
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发布单位或类别: 韩国-韩国标准
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