KS P ISO 20776-1-2020-传染病药敏试验和抗菌药敏试验装置性能评价第1部分:试验抗菌剂体外抗感染性快速生长需氧菌活性的肉汤微稀释参比法疾病（ISO 20776-1-2019 包括修订版2019-12） -国家数字标准馆

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감염원 감수성 시험과 항균제 감수성 기기 성능 평가 — 제1부: 감염성 질환과 관련 된 급속증식 호기성 세균에 대한 항균제의 체외작용 시험용 액체배지 미량 희석 기준시험법 传染病药敏试验和抗菌药敏试验装置性能评价第1部分:试验抗菌剂体外抗感染性快速生长需氧菌活性的肉汤微稀释参比法疾病（ISO 20776-1-2019 包括修订版2019-12）

发布日期： 2020-12-30

                该标准解释了判断MIC的一种经过认证的试验方法液体培养基微量稀释法（肉汤微量稀释法）。MIC反映了说明的试验条件下的药品作用，考虑到医药药理学或细菌耐药性机制等其他因素，可以解释为临床管理目的。通过它，可以将细菌分类为“感受性（S）、“中间耐性（I）”或“耐性（R）”，也可以通过MIC分布定义野生型或非野生型细菌群体。MIC值的临床解释超出了该标准的适用范围，但为了便于临床解释，为了特定的抗菌剂-细菌组合，必须修改基本方法。这些修改包括在单独的表格中。为了确保比较及可靠的结果，建议将其他感受性试验方法（例如，日常方法或诊断试验仪器）与经认证的试验方法进行比较验证。

이 표준은 MIC 판단을 위한 하나의 인증된 시험방법인 액체배지 미량 희석법(broth microdilution)에 대 해 설명한다. MIC는 설명된 시험 조건에서의 의약품 작용을 반영하며, 의약품 약리학 또는 세균 내성메 커니즘 등 기타 요인을 고려하여 임상관리 목적으로 해석할 수 있다. 이를 통해 “감수성(S),” “중간내성 (I)” 또는 “내성(R)”으로 세균을 분류할 수 있으며, MIC 분포를 통해 야생형 또는 비야생형 세균집단을 정의할 수도 있다. MIC값의 임상적 해석은 이 표준의 적용범위를 벗어나지만 임상적 해석을 용이하게 하기 위한 특정 항균제－세균 조합을 위해서는 기본 방법을 수정해야 한다. 이러한 수정사항은 별도의 표에 포함되어 있다. 비교 및 신뢰 가능한 결과를 확보하기 위해 다른 감수성 시험방법(예를 들어, 일상 적 방법 또는 진단 시험 기기)을 이 인증된 시험방법과 비교하여 검증하는 것이 권장된다.

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发布单位或类别：韩国-韩国标准

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