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现行 KS P IEC 62366-1-2018
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의료기기 — 제1부:의료기기에 대한 사용성 공학 적용 医疗器械.第1部分:可用性工程在医疗器械上的应用
发布日期: 2018-11-05
该标准规定了制造者分析、规定、开发和评价与安全相关的医疗器械可用性的过程。通过该使用性工学(人机工程学)流程,制造商可以评估和缓解正确使用和使用错误,即与正常使用相关的风险。该过程可用于识别与非正常使用相关的风险,但不能用于评估或缓解该风险。
이 표준은 제조자가 안전과 관련된 의료기기의 사용성을 분석, 규정, 개발 및 평가하는 프로세스를 규정한다. 이 사용성 공학(인간공학) 프로세스를 통해 제조자는 올바른 사용과 사용 오류, 즉 정상 사용과 관련된 위험을 평가하고 완화할 수 있다. 이 프로세스는 비정상 사용과 관련된 위험을 식별하는 데는 사용할 수 있지만, 이 위험을 평가하거나 완화하는 데는 사용할 수 없다.
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