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<AUTHOR>법제처 법령정보센터</AUTHOR>
<DATE>2025.11.25</DATE>
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<CHAR>&nbsp;국가법령정보센터</CHAR>
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<TEXT CharShape="12"><CHAR>[시행 2020. 12. 18.] [보건복지부고시 제2020-295호, 2020. 12. 18., 일부개정.]</CHAR>
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<P ParaShape="17"><TEXT CharShape="25"><CHAR>보건복지부(의료기관정책과), 044-202-2479</CHAR></TEXT></P>
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{전문}
<P ParaShape="23"><TEXT CharShape="6"><CHAR>제1조(목적)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 이 규칙은 「의료법」제36조 및 「의료법 시행규칙」제39조의2에 따라 의료기관에서 환자의 처치에 사용되는 기구 및 물품(1회용품은 제외한다. 이하 ‘기구’라 한다)에 대한 소독 등의 방법에 관하여 필요한 사항을 규정함을 목적으로 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제2조(정의)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 이 고시에서 사용하는 용어의 뜻은 다음과 같다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. "세척(Cleaning)"은 대상물로부터 모든 이물질(토양, 유기물 등)을 제거하는 과정을 말한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. "소독(Disinfection)"은 생물체가 아닌 환경으로부터 세균의 아포를 제외한 미생물을 제거하는 과정을 말한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 낮은 수준 소독(Low-level disinfection)은 10분 이내에 대부분의 영양성 세균과 일부 진균, 바이러스를 사멸시키나, 결핵균과 아포를 사멸시키지 못하는 것을 말한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 중간 수준 소독(Intermediate-level disinfection)은 결핵균과 영양성 세균, 대부분의 바이러스와 진균을 사멸시키나 아포는 사멸시키지 못하는 것을 말한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    다. 높은 수준 소독(High-level disinfection)은 모든 미생물과 일부 세균의 아포를 사멸할 수 있는 것을 말한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. "멸균(Sterilization)"은 물리적, 화학적 과정을 통하여 모든 미생물을 완전하게 제거하고 파괴시키는 것을 말한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제3조(감염위험도에 따른 기구 분류)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 의료기관에서 환자의 처치에 사용되는 기구는 환자와의 접촉 방법이나 상황에 따라 고위험기구, 준위험기구 및 비위험기구로 분류될 수 있으며, 필요한 개념에 따라 적절한 멸균 및 소독방법에 의해 관리되어야 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 고위험기구(Critical instrument)는 무균 조직이나 혈관에 삽입되는 기구로 어떤 미생물이라도 오염이 되면 감염의 위험이 매우 높다. 수술기구, 혈관카테터, 이식물, 무균조직에 사용되는 초음파 프로브 등이 여기에 속한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 멸균과정이 요구되며, 고온멸균법, 가스멸균법, 액체 화학멸균법 등을 이용한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 멸균된 채로 구매하거나 의료기관내에서 적절한 방법으로 멸균하여 사용하도록 하며, 사용 전에 멸균상태를 확인한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 준위험기구(Semicritical instrument)는 점막이나 손상이 있는 피부에 접촉하는 기구로 호흡치료기구, 마취기구, 내시경 등이 여기에 속한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. ‘높은 수준’의 소독이 요구되며 화학소독제를 사용한 경우 잔류 소독제가 없도록 멸균증류수로 깨끗하게 헹군다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 열에 안전한 의료기구인 경우에는 고온 멸균을 이용한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    다. 수돗물을 사용해야만 하는 경우라면 사용 후 알코올로 헹구고 압력이 있는 공기로 건조한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 비위험기구(Noncritical instrument)는 손상이 없는 피부와 접촉하지만 점막에는 사용하지 않는 기구로 혈압측정기, 청진기, 심전도 도구, 방사선 촬영용 카세트 등이 여기에 속한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. ‘낮은 수준’의 소독을 적용하며, 사용한 장소에서 소독하여 재사용할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제4조(멸균 및 소독방법)</CHAR></TEXT><TEXT CharShape="5"><CHAR> ① 의료환경에서 사용하는 기구의 범주와 요구되는 소독수준에 따른 멸균 및 소독방법은 별표 1과 같다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ② 의료기구는 소독과 멸균 전 세척을 시행하여야 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ③ 멸균 및 소독에는 식품의약품안전처에 신고 및 허가받은 의약품, 의약외품,의료기기 등을 사용하여야 하고, 각 제품의 사용방법을 준수하여야 한다. 다만, 중간 또는 낮은 수준의 소독에는 미국 FDA, 유럽 CE, 일본 후생성 또는 보건복지부장관이 따로 인정하는 기관에서 인증(허가, 신고, 등록 등 포함)을 받은 제품을 인증 용도에 따라 사용할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제5조(멸균시 주의사항)</CHAR></TEXT><TEXT CharShape="5"><CHAR> ① 멸균방법은 멸균 여부를 확인할 수 있는지, 내부까지 멸균 될 수 있는지, 물품의 화학적, 물리적 변화가 있는지, 멸균 후 인체나 환경에 유해한 독성이 있는지, 경제성 등을 고려하여 선택하도록 한다. 멸균시 주의사항은 다음 각 호와 같다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 멸균 전에 반드시 모든 재사용 물품을 세척해야 한다. 만약 유기물이 잔존할 경우에는 미생물이 사멸될 수 없다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 멸균할 물품은 건조시켜야 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 물품 포장지는 멸균제가 침투 및 제거가 용이해야 하며, 저장 시 미생물이나 먼지, 습기에 저항력이 있고, 유독성이 없어야 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  4. 멸균물품은 챔버 내 용적의 60∼70%만 채워 멸균제의 통기가 원활하게 하여야 하며, 가능한 같은 재료들을 함께 멸균한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제6조(멸균확인 등)</CHAR></TEXT><TEXT CharShape="5"><CHAR> ① 멸균공정이 제대로 수행되는지를 다음 각호의 방법을 통해 확인해야 하며, 이를 확인하기 위해 멸균과 관련한 기록(멸균기록, 멸균기의 정기검사 및 유지보수 기록, 물품 회수 기록 등)을 관리해야 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 기계적/물리적 확인(Mechanical/Physical)</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>1) 멸균과정 동안의 진공, 압력, 시간, 온도를 측정하는 멸균기 소독 챠트(chart)를 확인하는 방법으로 멸균기 취급자는 멸균 과정 동안 멸균 사이클을 표시하고 기록계를 확인해야 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>2) 이 방법은 멸균기 내부의 모든 부분에 대한 자료가 아니라 멸균기 내부의 한 시점에서의 상태를 나타내는 것이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 화학적 확인(Chemical indicator)</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>1) 멸균 과정과 관련된 하나 혹은 두 가지 이상의 변수의 변화에 의해 시각적으로 반응하는 민감한 화학제를 이용하는 방법이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>2) 이 방법은 잘못된 포장이나 잘못된 멸균기 적재 혹은 멸균기의 오작동으로부터 발생할 수 있는 잠재적인 멸균실패를 발견하는데 이용된다. 외부 화학적 확인은 모든 물품의 외부에 부착하여 실시하고, 내부 화학적 확인은 모든 멸균 물품 내부에서 시행한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 생물학적 확인(Biological indicator)</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>1) 멸균과정에 저항력이 있다고 알려진 표준화되고 생육력이 있는 미생물(일반적으로 박테리아 포자)로 구성되며 멸균 조건이 멸균 성공에 이를 정도로 적절한 지를 증명하기 위하여 이용하는 방법이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>2) 멸균과정 동안 멸균이 잘 안 되는 곳에 멸균기의 종류에 따라 Geobacillus stearothermophilus 나 Bacillus atrophaeus 와 같은 생물학적 지시기를 사용한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>3) 멸균 후 biological indicator 내의 세균을 배양하여 멸균 여부를 확인한다. 이 방법은 매일 하는 것이 이상적이나 적어도 주1회 이상 실시하는 것이 바람직하다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>4) 멸균기를 처음 설치하였을 때나 멸균기의 주요한 수리 후, 멸균기의 위치변경 및 환경적인 변화가 있을 때, 설명할 수 없는 멸균실패가 발생했을 때, 스팀 공급 및 공급라인의 변화, 물품의 적재방법 등의 변화가 있을 때에는 멸균기가 비어있는 상태에서 생물학적 지시기를 사용하여 연속 2회 검사를 시행한다. 2회 모두 멸균판정이 이루어졌을 때 멸균기를 가동시키도록 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ② 멸균 물품 사용 전 유효기간, 보관 조건, 포장상태 등을 확인하여 멸균이 유지된 경우 사용한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제7조(재검토기한)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 보건복지부장관은「훈령·예규 등의 발령 및 관리에 관한 규정」제7조에 따라 이 고시에 대하여 2020년 6월 22일을 기준으로 매 3년이 되는 시점(매 3년째의 2023년 6월 22일까지를 말한다)마다 그 타당성을 검토하여 개선 등의 조치를 하여야 한다.</CHAR></TEXT><TEXT CharShape="7"/></P>
<P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2020-295호, 2020. 12. 18.&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>이 고시는 발령한 날부터 시행한다.</CHAR></TEXT><TEXT CharShape="7"/></P>


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