滅菌ハンドブック

発行によせてこの度、私の 20 年来の友人でありますドイツ

チュービン大学病院

中央滅菌材料室ディレクター

のトニー・ザネッティー氏の多大なるご協力とご尽力により、ドイツ、スイスの中央滅菌材料室の教育に現在も実際に使用されている『滅菌ハンドブック 第 5 版』を日本語に翻訳し、日本の皆様にご覧い
ただける機会を得ましたことを大変喜んでおります。
日本では、米国のガイドラインなどが翻訳され、また、それを引用した講演、講義などが非常にたくさん行われており、それにより米国の情報提供と言う意味では大きな役割を果たして来たと思われます。
特定非営利活動法人日本感染管理支援協会でも、2011 年に米国の中央滅菌材料室の実践者で構成される学会（IAHCSMM）が発行する『セントラルサービストレーニングマニュアル 第 7 版』を翻訳し、広く日本の方々へ正しい情報を提供して参りました。しなしながら、この米国の情報だけでは、日本の皆様に対して情報の偏りがあり、それぞれの本質を見抜けぬまま誤解されないかと、私は大変危惧しておりました。
そこで、今回情報の偏りと言う懸念事項を払拭する為に、年間数回にわたり情報交換の為に訪問しているドイツの中央滅菌材料室の情報を、チュービンゲン大学病院のトニー・ザネッティー氏からご紹介を受け、『滅菌ハンドブック 第 5 版』を日本の皆様へお届けすることができるようになり、このことは喜びに堪えません。
少し本書のことについて触れますが、それぞれの項目で皆様が知りたい内容を、しっかりと理論を述べて詳細に説明しているところは

流石ドイツの実践書と唸らせる一方、日本では数少ないこの領域のドイツ語の翻訳書でありますので、今まで独り歩きしていた様々な情報を整理するには大変役に立つ書籍であることには間違いありません。
理論をしっかり述べ詳細に説明していると言うことは、自分の知識の深まりと共に、同じ文章を何度も繰り返し読むことにより、更なる深みと広がりのある文章であることに気づかされ、不思議な感覚に驚きを覚えることなると思います。
さて、折しも日本では、日本医療機器学会から『医療現場における滅菌保証のガイドライン 2015』が公表されたこともありまして、日本の情報も皆様に届くことになりました。この日本のガイドラインと、特定非営利活動法人日本感染管理支援協会がご提供するアメリカ、ドイツの翻訳書を加えていただ
くことで、中央滅菌材料室のそれぞれの本質を広く深く知っていただく機会が整いました。これらを熟読していただき、自施設の中央滅菌材料室の更なる質保証を是非とも推進していただけることを懇願しております。
最後に、この翻訳本を販売することにあたり翻訳をご担当してくださいました竹之内 悦子 女史、ならびに、多大なるご協力をいただきましたスポンサー企業に心よりお礼申し上げます。
2016 年 2 月
特定非営利活動法人日本感染管理支援協会
理事長

土井

英史

目

次

1 滅菌の歴史 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 12 微生物学の基本 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 52.2.1

導入 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 5（真正）細菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 5
感染とコロニーの形成 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 62.2.2

細菌の可視化、培養、特定

2.1
2.2

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 7−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 7培地の上での細菌の培養 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 7
細菌の種類を特定するための生化学的テスト −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 7
血清学的特定方法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 7
細菌の染色体を直接検証することによる特定 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 78抗菌薬に対する感受性の特定 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
ヒトにとって重要な病原細菌の例 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 8
グラム陽性球菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 8
グラム陰性球菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 9
グラム陽性桿菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 9
グラム陰性桿菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 9グラム染色によって検証できない病原菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 9
真菌類 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 10
カンジダ症（鷲口瘡） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 10
アスペルギルス症 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 11
ニューモシスティス症 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 11ウイルス −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 11ウイルスの分類 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 12
ウイルス感染の経過、診断及び治療 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 13
医療機関スタッフの感染の危険 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 13
B 型肝炎と C 型肝炎、HIV 感染 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 13
プリオン −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 14
病原体となる他の微生物 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 15
顕微鏡標本

2.2.3

2.3
2.3.1
2.3.2
2.3.3
2.4
2.4.1
2.4.2
2.4.3
2.5
2.6

3 医療機器の器械学と機器の手入れ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 17−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 17−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 17
材料 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 17
材料記号と略号 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 18
外科機器の表面の性質と表面加工 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 19
特殊材料 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 20
まとめ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 22
医療機器の器械学 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 22
外科機器の作り方、鉗子を例に −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 22
機器に関する知識 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 24
メス −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 24
剪刀 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 24
鑷子 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 25

3.1

導入

3.2

基本

3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.3
3.3.1
3.4
3.4.1
3.4.2
3.4.3

3.4.6

鉗子 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 26
持針器 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 27
開創鈎 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 28

3.4.7

開創器

3.4.8

低侵襲手術（M15）機器

3.4.4
3.4.5

3.5
3.6
3.6.1
3.6.2

3.6.3
3.6.4
3.7
3.7.1
3.7.2

3.8
3.8.1
3.8.2
3.8.3
3.8.4
3.8.5
3.9
3.10
3.11
3.12

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 29−中空軸機器 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 29
医療機器の循環 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 30
手術での機能に合った機器の使用 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 31
機器の回収 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 31
洗浄と消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 32
用手洗浄と消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 32
超音波洗浄 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 33
機械洗浄と消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 33
機器の手入れと機能チェック −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 34
包装と滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 35
表面の変化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 35
表面の変化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 35
有機残渣 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 35
化学薬品の残渣によるしみ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 35
石灰によるしみ／薄層 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 36
ケイ酸塩／無機物によるしみ／薄層 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 36
平面の酸化による変色／有色のプラズマコーティング層の退色 −−−−−−−−−−−−−−−−−−−−−− 36
孔食 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 37
応力腐食割れ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 37
擦過腐食 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 37
すきま腐食 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 37
接触腐食 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 38
外面腐食 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 38
他の腐食の飛び火 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 38
合成樹脂の応力亀裂 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 38
機能試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 39
剪刀 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 39
切骨鉗子、骨はじき鉗子及び椎弓切除用骨鉗子 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 39
持針器 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 40
鑷子 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 40
鉗子 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 40
外科機器の修理と新たな再生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 40
メーカー、修理業者及び使用者への要求事項 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 41予想できる機器の欠陥 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 42
機器の手入れ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 42

4 中材及び開業医の衛生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45

4.3

導入 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45
中材の課題 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45
中材の運営上の枠組み条件 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45

4.3.1

病院衛生と中材

4.3.2

労働安全

4.1
4.2

4.3.3
4.4
4.4.1

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45
医療機器再生に関する法律及び規格の要求 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 45
部門の衛生と個人の労働衛生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 46
空間の分離 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 46
食事 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 46
清掃 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 46
面の消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 46

4.4.2

4.4.3
4.5
4.5.1

作業用及び部門専用の服装 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−46
頭髪／髪の保護 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−47
腕及び指のアクセサリー −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 47
部門専用の履物 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 47
手指の衛生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 47
使い捨て手袋 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 47
標準衛生措置と予防措置 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 47
手指衛生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48
使い捨て手袋 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48

4.5.2

保護用ガウン、エプロン −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48
口腔、鼻及び眼の保護 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48
面の消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48

4.5.3

傷つける危険性のある機器の安全な回収

4.5.4
4.5.5
4.6
4.6.1
4.6.2
4.6.3

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48

補足的保護措置 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 48
作業場所での血液による感染の防止 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 49
中材の衛生計画 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 49
面の洗浄と消毒：準備側 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 49
面の清掃と消毒：無菌物保管庫を含む清掃 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 49
面の清掃：非居住空間 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 50

5 消毒とその応用 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−51−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 51−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 51
滅菌との区別 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 51
物理的消毒法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 53
化学薬剤による消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 53
殺微生物作用の多様性と効果試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 53
消毒の標的である微生物 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 53
消毒作用物質と消毒剤の定式化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 54
消毒剤耐性は本当に問題なのか ? −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 56求められる効果／消毒剤の定義された効果 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 58
消毒剤の試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 60
消毒剤 − 医学分野での適用 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 62
衛生的手指消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 62
面の消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 63
機器の消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 64
医療機器の消毒と再生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 64
機器の循環 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 64
機器と機器の消毒剤の分類 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 65
正しい機器消毒剤の選択 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 66
熱と化学薬剤を組み合わせた消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 68
消毒剤溶液の再利用ないしは浸漬効果持続期間 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 71
超音波洗浄装置で使われる消毒剤 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 71
作業の安全と機器消毒剤 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 72
機器の消毒剤と医療機器法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 74

5.1

消毒の基本

5.1.1

消毒と概念

5.1.2
5.1.3
5.1.4
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.3
5.3.1
5.3.2
5.3.3
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8

6 医療機器の洗浄と消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 75
6.1
6.2
6.2.1

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 75−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 75
ズィンナーの円環 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 76
温度 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 76
物理的力 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 76
導入

洗浄の一般的基礎

6.2.2

薬品 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
時間 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
洗浄という化学的・物理学的事象 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
77
剥離 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
膨張 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
乳化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
分散 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 77
汚れ保持力 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 786.3
処理用化学薬剤 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 786.3.1
処理用化学薬剤の種類 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 786.3.2
内容物質とその機能 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 80
6.4
水質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 82
6.5
汚染／汚れ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 846.6
材料の挙動／材料保護 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 846.6.1
材料保護 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 84
6.6.2
熱消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 84
6.7
洗浄工程 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 85
6.7.1
予備洗浄 − 予備処理 − 超音波洗浄 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 85
6.7.2
通常の工程の流れ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 86
耐熱性医療機器用プログラムの流れは −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 86
非耐熱性医療機器向けプログラムの流れは −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 87
6.7.3
特殊な工程 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 87
変異型クロイツフェルト・ヤコブ病／クロイツフェルト・ヤコブ病向けプログラム −−−−−−−−−−−− 87「BGA（ドイツ連邦保健局）プログラム」あるいは「伝染病プログラム」 −−−−−−−−−−−−−−−−−−−− 886.8
試験方法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 89
6.8.1
EN ISO 15883 による試験の概観 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 89
扉、ロックおよびエラーメッセージの試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 89
温度の推移と熱を使った消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 89
計量と用量 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 89
洗浄性能 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 89
6.8.2
以下の措置は洗浄性能試験の一部である −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
目視点検 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
試験用の汚れ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
生物学的インジケータ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
噴射システムの点検 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
6.8.3
残留タンパク質による汚れを検証し評価する試験方法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
OPA 法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 90
ニンヒドリン法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 91
ビウレット法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 91
6.8.4
乾燥 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 916.8.5
処理用化学薬剤の残渣 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 91
6.9
洗浄及び消毒工程の定期点検 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 91
6.9.1
機器の清浄度と乾燥度の目視検査 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 91
6.9.2
プロセスパラメータの監視 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 91
6.9.3
洗浄性能 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 92
汚れ試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 92
6.10
運転日毎に行う試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 92
6.10.1 試験方法の概観 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 93
6.11
機械的及び用手再生のための実践的指示 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 94
6.11.1 回収／輸送 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 94
6.11.2 作業場所の構成 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 94
溶解／分解6.11.3

除染 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 95
機械的洗浄と消毒 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 95
医療機器の機械的洗浄及び消毒の一般的手順 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 96−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 96−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 96
消毒剤溶液の調合 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 97
超音波 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 97
医療機器用のウォッシャーディスインフェクター（WD） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 101
WD の重要な性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 101
オペレーター／使用者に対する要求事項 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 103
医療機器再生用の様々な WD のタイプ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 103
1 チャンバー式 WD −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 103
複数チャンバー式 WD ／サイクル型 WD（前後して複数のチャンバーが接続されているタイプ）−−−− 104
卓下型及び卓上型 WD −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 105
軟性鏡用 WD −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 105
コンテナ洗浄設備／カート洗浄設備 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 106
ラック、運搬カート −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 106
内腔のない外科機器用ラック、積載面 3 ～ 6 段 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 106
最終点検

6.11.4

6.12
6.12.1
6.12.2
6.12.36.12.46.12.5

用手洗浄及び消毒3 ～ 6 段の積載面を持つ外科機器用ラック、カニューレ及び内腔を持つ個々の機器の内側洗浄用接続システム付き−−−−−−−−−−−−−−−−−−−−− 106

低侵襲手術機器用ラック（MIS 用ラック） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107
眼科機器用ラック −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107
コンテナ用ラック −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107
医療機器とコンテナを組み合わせて積載するラック −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107
手術用履物のラック −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107
専用ラック −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 107
洗浄／消毒工程のバッチの文書化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 108
洗浄及び消毒工程のバリデーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 108
基本的一般的要求事項と試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 108
バリデーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 109
据付時適格性確認（IQ） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 109
運転時適格性確認（OQ） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 109
稼働性能適格性確認（PQ） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 109
再度の稼働性能適格性確認 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 110
マイクロ手術機器用ラック
麻酔材料用ラック6.12.66.13
6.13.17 包装 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 111
7.1

導入−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 111

7.2

無菌物包装の歴史 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 111
無菌物包装向け規格の成立 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−111
重要な規格一覧 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−1137.3

無菌バリアシステムに対する一般的要求事項

7.1.1
7.1.2

7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.3.8
7.4

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 113

定義 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 113
無菌バリアシステムは何を果たす必要があるのか？ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 114
医療機器との適合性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 114
滅菌方法との適合性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 115
微生物に対する効果的なバリア、ないしは使用までの無菌性維持 −−−−−−−−−−−−−−−−−−−−−−−− 116
透過性無菌バリアシステム材料の濾過効果 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 116

無菌提供のサポート −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 117
包装に対するその他の一般的要求事項 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 117
KRINKO（病院衛生・感染症予防委員会）− BfArM（医薬品・医療機器連邦研究所 ) の再生に関する新たな勧告 −−−− 118

7.5
7.5.1
7.5.2

無菌バリアシステムの包装システム −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−118
硬質包装：滅菌容器（コンテナ）と定期点検 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 118
セットの包装（ラッピング）用フレキシブルな包装材料 −−−−−−−−−−−−−−−−−−−−−−−−−− 119−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 119−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 120
透明包装 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 120
シール工程 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 122
適切なヒートシーラ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 122
ロータリーシーラ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 122
インパルスシーラ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 123
ヒートシーラに対する要求事項 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 123
ヒートシーラ新規購入のためのチェックリスト −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 123
定期点検 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 123
完全性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 123
剥離性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 125
シーム強度 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 125
包装工程のバリデーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 126
DIN EN 11607-2 による DGSV（ドイツ無菌物供給協会）の包装工程バリデーションに関するガイドライン −−−− 126
ヒートシール工程のバリデーション（機械工程） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 127
用手包装工程のバリデーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−127
包装システムの識別表示 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−128
輸送と保管 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 129
無菌医療機器保管期間の限定 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−129
多重包装／保護的包装の意義 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−129
異なる材料タイプの取り扱いの比較

7.5.3
7.5.4
7.6
7.6.1

7.6.2
7.6.3
7.7
7.7.1
7.7.2
7.7.3
7.8
7.8.1
7.8.2
7.8.3
7.9
7.10
7.10.1
7.10.2

包装技術

8 滅菌の基本 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 131
9 蒸気滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 1339.3

標準化された方法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 133
滅菌器 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 133
飽和水蒸気 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 1349.3.1

水蒸気を作る

9.3.2

効果

9.1
9.2

9.3.3
9.3.4
9.4
9.4.1
9.4.2
9.4.3
9.5
9.6
9.7

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 135−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 136
凝縮 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 137
非凝縮性気体 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 138
工程技術 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 139
被滅菌物が滅菌結果に及ぼす影響 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 141
包装が滅菌結果に与える影響 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 142
積載が滅菌結果に及ぼす影響 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 143
バリデーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−144
日常的監視と文書化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 148
まとめ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 150

10 過酸化水素低温プラズマ滅菌法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−151
10.1
10.2
10.2.110.2.2
10.3
10.4
10.4.1
10.4.2−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−151
物理的及び化学的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 151
物理的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 151
化学的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 151
殺微生物作用 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 153
反応動力学 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 154
D 値、SAL（無菌性保証水準）及びオーバーキル法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 155
蒸気滅菌の反応動力学 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−・156
導入

10.4.3
10.5
10.6
10.7
10.7.1
10.7.210.8

過酸化水素低温プラズマ滅菌法の反応動力学 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−157
滅菌器技術 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 159
工程管理 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−161−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−163−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−165
オペレーターの微生物学的稼働性能適格性確認（PQ） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−166
まとめ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 166
バリデーション

メーカーによる効果限界の算出とバリデーション

11 ホルムアルデヒド滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−167
11.1
11.1.111.1.2
11.1.311.1.4
11.2
11.3
11.3.1
11.3.2
11.4
11.5
11.5.1
11.5.2
11.5.311.5.4
11.6
11.7
11.7.1
11.7.2
11.8
11.9
11.10
11.11
11.12
11.13

低温蒸気ホルムアルデヒド法（LTSF）滅菌の基本 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 167
物理的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 167
化学的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 167
生化学的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 168
毒性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−168
水蒸気とホルムアルデヒドを使う滅菌 − 合理的代替方法か ? −−−−−−−−−−−−−−−−−−−−−−−−169
低温蒸気ホルムアルデヒド（LTDF）滅菌の工程技術 −−−−−−−−−−−−−−−−−−−−−−−−−−−−− 170
滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 170
脱離 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 172
滅菌器の構造 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 172
工程管理 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 174
コンディショニング（脱気、蒸気浸透及びホルムアルデヒド注入） −−−−−−−−−−−−−−−−−−− 175
平衡時間 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 175
滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 176
脱離 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 176
低温蒸気ホルムアルデヒド（LTSF）滅菌法の試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 177
低温蒸気ホルムアルデヒド（LTSF）滅菌工程の試験 −−−−−−−−−−−−−−−−−−−−−−−−−−−−− 177
バリデーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−177
微生物学的 PQ 用工程試験用具 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 179
低温蒸気ホルムアルデヒド（LTSF）滅菌器の運転 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 180
滅菌包装 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 181
リリースの文書化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 182
低温蒸気ホルムアルデヒド（LTSF）滅菌器の運転に関する特別な法的義務 −−−−−−−−−−−−− 183
構造上の要求事項 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 184
結び −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 184

12 酸化エチレン滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−18512.2.1

導入 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−185
酸化エチレンの基礎 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−185
物理的性質 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 185

12.2.2

化学的性質12.2.3

生化学的性質12.1
12.2

12.2.412.3
12.3.112.3.212.3.312.3.412.4
12.4.112.4.212.4.312.5−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 185−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−185
なぜ酸化エチレン滅菌なのか？ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−186
酸化エチレン滅菌の工程技術 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−186
作用物質濃度 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−187
湿度 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−187
温度 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−187
曝露時間 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−187
滅菌方法の安全性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−188
毒性 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−188
建築上の前提条件 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−188
機器技術 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 189
ガス混合物を使う陽圧法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−18912.6
12.6.1

酸化エチレン・カートリッジを用いる陰圧法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−189
第 1 段階：コンディショニングあるいはチャンバー内での調整 −−−−−−−−−−−−−−−−−−−−−−190
予備加熱 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−190
加湿12.6.2−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−190

第 2 段階：ガス段階 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−191
ガス注入 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−191
曝露 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−191
最終真空引き−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−19212.6.3フレッシュエアによるエアフラッシング −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−192
換気 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−192
第 3 段階：脱離あるいはガス抜き −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 193

12.7

滅菌後の酸化エチレンの処理

12.7.1

加水分解−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 193−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 193
12.7.2 後燃焼 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 194
12.7.3 触媒法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 194
12.7.4 連続 Sorpkat® 法 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 19412.8
酸化エチレン滅菌に関する運転及び運営上の前提条件 −−−−−−−−−−−−−−−−−−−−−−−−−−− 194
12.8.1 操作スタッフの職業教育 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 194
12.8.2 一般的衛生措置 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−19512.9
酸化エチレン滅菌される医療機器 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 195
12.9.1 使い捨て医療機器の再生と再滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 195
12.9.2 滅菌前工程 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 19512.10
品質保証 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 19512.10.1 機械に関する文書 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 196
12.10.2 無菌物に関する文書 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 196
12.11
結び −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 196

13 中材における機能上及び建築上の前提条件 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−197
13.1
13.2
13.2.1

病院内の中材の位置 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−197
室内設備 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−198
納入及び除染領域（「準備側」） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−19913.2.3

包装及び分別領域（清潔側） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 199
滅菌後の領域 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 200

13.2.4

経営及び横断的部門

13.3

機能上及び建築上の前提条件

13.2.213.3.1

13.4−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 200−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 200
建築上の要求事項 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 201
換気設備のある施設 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 201
機械設備 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 202
まとめ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 203

14 規格とその意味 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 205−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 205−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 206
再生にとって重要な規格 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 207
全ての規格は原則として同じ構成である −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 207
洗浄／消毒に関する重要な規格は −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 208
滅菌自体に関する重要な規格は −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 208
以下の製品規格は上記プロセス規格と密接に結びついている −−−−−−−−−−−−−−−−−−−−−−− 208
個々の規格の相互作用 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 21014.1

規格への導入

14.2

規格の成立

14.3
14.3.114.3.214.3.314.3.414.4

15 スイスにおける法的基礎 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211
15.1

スイスの法体系への導入 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−21115.1.3

国 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211
州 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211
課題 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211
市町村 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211

15.2

中材にとって最も重要な官庁

15.1.115.1.215.2.115.2.215.2.315.2.415.2.515.3
15.3.115.4
15.4.1−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211
スイス連邦保険局（BAG） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−211
BAG の最も重要な課題分野は −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 211
スイスメディック（Swissmedic スイス連邦医薬品局） −−−−−−−−−−−−−−−−−−−−−−−−−−−− 212
連邦経済省経済事務局（seco） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 212
スイス労働災害保険社（SUVA） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 212
連邦医薬品・医療機器法（医薬品法、HMG） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 212
目的 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−212
適用範囲 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 212
医療機器規則（MepV ） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 214
医療機器の維持補修・再生の責任 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 214
再生 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 214
大型滅菌器 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 214
第三者のための滅菌 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215
その他の情報 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215
変更 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215
整合性手続き（医療機器法 812.213 第 1 条 1 項） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215
整合性評価手続き −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215
整合性評価機関が援用されるのは −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215
ISO/EN 規格化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 215

16 品質管理 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 217−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 217−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 217
病院内の品質管理システム −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 217
品質管理システムの導入 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−218
品質管理の文書化 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 218
品質管理における実際的課題 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−219
品質計画の目標（計画） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 219
品質管理の目標（実行） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 219
品質保証の目標（品質保証） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−219
品質改善の目標（期待と現状の比較→措置） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 220
品質管理システムの制御体系 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 220
経営陣の責任 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 220
経営陣の義務 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 220
顧客重視 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 221
品質方針 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 221
計画 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 221
責任、権限及びコミュニケーション −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 221
管理の評価 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 221
中材管理者の責任 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 221
システムに関わるデータ／文書 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 222
より包括的データ／文書 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 223
資源管理 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 223
資源の準備 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 223
人材 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 223
インフラ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 223
作業環境 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 223

16.1

導入

16.2

定義

16.3
16.4
16.4.1
16.4.216.5
16.5.1

16.6
16.6.1

16.6.2

16.6.3製品の実現 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 224−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 224

製品実現の計画−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−224−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−224
調達 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−224
生産とサービスの提供 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 224
本来の中心業務 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 225
再生の循環 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 226
工程及び作業指示書 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−226
監視・測定手段の管理 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 226
顧客は王様 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 227
測定、分析及び改善 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−227
全般 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 227
監視と測定 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 227
欠陥の管理 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 228
データ分析 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 228
改善 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−228
まとめ −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 229
顧客に関わるプロセス
開発

16.7
16.7.1
16.7.216.8
16.8.116.9

語彙集 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−231
略語一覧 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 265
文献一覧 −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− 269
275
スポンサー一覧（原本に記載のスポンサー） −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−

第6章

第6章

医療機器の洗浄と消毒

75

医療機器の洗浄と消毒
アンケ・カーター，ノーマ・ヘルマン，コルネリア・フーゴー
ヴェローナ・シュミット，マティアス・チェルナー

6.1 導入

医療機器再生に対する要求は、ロベルト・コッホ研究所（RKI）の病院衛生及び感染予防委員会と医薬品・医療機器連邦研究所（BfArM）の勧告に説明されている（［62］補遺の文献目録参照）。この指令に従えば、再生には通常以下の個別の段階が含まれる。
●

専門的に適切な準備●

洗浄／消毒、すすぎと乾燥●

清浄度と傷のないことの検査●

手入れと修理

●

識別表示

●

包装，及び

●

滅菌
規定によれば病原菌の少ないあるいは無菌の医療機器の包装が、開封されたあるいは損傷した場合、あるいは医療機器が適用されがなかった場合、上に説明された再生が適用される。
医療機器の設定、操作、使用及び保守を管理する医療機器オペレーター規制（MPBetreibV）§4 によれば、
適当なバリデーション済みの方法を用いた医療機器の洗浄、消毒、滅菌は、その方法の結果が後から検証できる形で保証され、患者、使用者及び第三者の安全と健康が危険に曝されないように実施される。
▼▼

ブックマーク

確実で効果的な滅菌は、清潔な医療機器でしか実現されない。従って洗浄は再生の全体の流れの中で特別重要である。
洗浄、消毒、すすぎ及び乾燥は、用手及び機械的方法で行えるが、RKI によれば、特に標準化しやすさ及び労災防止という理由で、機械的方法が優先される。用手洗浄／消毒では、怪我や感染の危険性があり得ることを考慮しなければならない。従って適当な保護措置（例えば保護衣、ゴーグル、適当な手袋、室内環境の質）が提供、使用されなければならない。
用手洗浄・消毒は標準作業手順書（SOP、英語は standard operation procedure）に従って実施され、文書化される。
機械洗浄・消毒方法は、DIN EN ISO 15883 に従い、型式試験を受けた洗浄消毒器（ウォッシャー・ディ
スインフェクター）（WD）で、バリデーション済みの再生方法を用いて実施される［30］。
以下の章では洗浄と熱を用いた消毒の基礎、再生結果の検査方法、実践のヒントと、WD 及び相当す
る工程バリデーションに対する要求事項について説明する。

6.2 洗浄の一般的基礎

洗浄と言えば、好ましくない物質を、その後の再生にあるいは予定される使用に必要な程度まで表面から除去することと理解される。医療機器再生の洗浄では、好ましくない物質とは血液、分泌液、粘液あるいは他の組織や骨の構成要素である。微生物も洗浄で一定の程度まで除去される。優れた洗浄方法
は微生物を通常 99.9％（3log レベル）削減する。
洗浄は医療機器の再生で非常に重要な役割を果たす。清潔で菌のあまりついていない医療機器のみが、続く再生段階で確実に消毒、滅菌できるのである。残った汚れは●

化学消毒剤との相互作用を起こし、それによって消毒剤の効果が損なわれる可能性がある。

●

機器の腐食を引き起こす可能性がある。

●

微生物を確実な消毒あるいは滅菌から「守る」可能性がある。

76

滅菌ハンドブック

医療機器の洗浄から提供まで

コロニー形成単位
時間（分）図 6.1：消毒工程中の時間経過による微生物削減の例、単位：対象物当たりのコロニー形成単位

さらに消毒と滅菌の成果は最初の細菌数によって変わる（図 6.1）。
医療機器洗浄に対する要求事項は、一連の規格 DIN EN ISO 15883 に挙げられている。この場合、規格に説明された試験の合格判断基準が達成されていれば、洗浄は達成されたとみなされる。ドイツのバ
リデーション・ガイドラインによれば、機械洗浄・消毒工程の洗浄結果チェック用に、定められた形で汚染されたクライル止血鉗子が使われる。この場合 100 µg タンパク質／クライル止血鉗子の基準値を上回ってはならない［14］。
6.2.1 ズィンナーの円環
最適な洗浄結果を達成するか否かを決めるのは、様々なパラメータの相互作用である。このパラメー
タは円環の形で図示される（ズィンナーの円環）。円環が閉じればその洗浄は最適である。
▼▼

ブックマークズィンナーの円環は 4 つの主要パラメータである温度、時間、薬品、物理的力を表す。この 4 つが最適な洗浄結果を達成するのに必要である。
温度
温度を上げることで、物理学的及び化学的事象が加速される。例えば汚れを構成するものの膨張という物理学的事象がそれである。タンパク質の加水分解（分解）のような化学的事象も、タンパク質、脂肪及びデンプンの分解という酵素の作用による事象も同様に加速される。温度が上がるとさらに医療機
器表面から脂肪構成要素が剥がれやすくなる。但し温度が上がり過ぎると不都合が生じることもある。
タンパク質、脂肪、デンプンの分解を助けるように洗浄剤に酵素が添加されるが、温度が高過ぎると酵素の活性を下げる可能性があるのである。温度が比較的高い場合さらに、石灰沈着が発生することがあり、これが洗浄器内の石灰薄層形成につながる。従ってどの洗浄工程にも最適な温度を選ぶ必要がある。
物理的力
物理的力は特に、洗浄での静止摩擦の克服に役立つ。この静止摩擦によって汚れの粒子が機器表面に固定されるのである。例えばスプレーノズルから噴き出して WD 内の医療機器に作用する水によって物理的力が働く。内腔のある機器を水が流れ通る時にも物理的な剪断応力がはたらき、汚れが表面から剥がれるのを助ける。最後に用手洗浄に使われるブラシやスポンジのような補助手段も洗浄を力学的に支える。

第6章

医療機器の洗浄と消毒77

薬品
第 3 のパラメータは使われた洗浄剤の影響である。これはそれぞれの組成によって様々にプロセスを支える（熱と薬品を使った洗浄工程参照）。
時間
最後に、最適の洗浄結果を達成するには 3 つの要因が働けるそれなりの時間が必要である。
ズィンナーの円環を構成する要因はウェイトの置かれ方が異なることがある。用手洗浄工程では通常ブラシのような力学的補助手段が使われる。用手洗浄工程では補助手段が洗浄結果へ強い力学的影響を与えることで、温度が比較的低く、時間が比較的短いのを補う。
逆に WD 内の洗浄では、スプレーノズルから医療機器に伝わる力は、用手再生に比べてどちらかと言えば少ない。そこで WD では、より高い温度、より長い時間及び場合によってはより強力な洗浄剤が物理的力の不足を補うので、満足のゆく洗浄結果が得られるのである。
6.2.2 洗浄という化学的・物理学的事象
ズィンナーの円環で洗浄を化学的に補助する洗浄剤は、処理用化学薬剤として様々な課題を果たす。
洗浄中には以下の化学的・力学的事象が進行する。
剥離
洗浄作用物質を汚れと接触させるには、湿潤剤（界面活性剤）が役に立つ。というのも湿潤剤は水をはじく（疏水性の）残渣をも濡らす働きをするからである。さらに湿潤剤は汚れの下に潜り込んで汚れを表面から剥がし、洗浄剤溶液に吸収されるのを助ける。
溶解／分解
分解と溶解は重要である。汚れを構成する要素は分解と溶解が行われて初めて水溶性となり、洗浄剤
溶液によって運び出せるからである。汚れの構成要素の分解は洗浄剤の様々な内容物質によって可能になる。アルカリと酵素がその一例である。酸も無機残渣（石灰、尿石、錆）を分解し、汚れの構成要素
はそれによって水溶性となり洗い流せるようになる。
膨張
汚れを構成する要素が膨張することで、洗浄工程が汚れに近づきやすくなる。アルカリは膨張させる
内容物質の一つでもある。膨張は特に乾ききってしまった汚れの残り（例えば血液）に必要である。
乳化
脂肪は通常水不溶性で、洗浄剤の助けを借りずには表面から離すことも洗浄液で洗い流すこともできない。脂肪は、洗浄剤で洗い流せるように、いわゆる乳濁質に変えられる。この時脂肪の構成要素が、例えば界面活性剤の分子によって包まれる。小さな滴ができ、これが溶液中に浮かび、洗い流すことができる（図 6.2）。
分散
例えば全く水に溶けない骨粉、骨の削り屑のような、分解できない汚れの固体粒子がある。この場合
脂肪のような乳化もできない。ここでも洗浄剤の特別な構成要素が汚れの粒子を結合し、分散と呼ばれる浮遊状態に保つ。分散された微粒子（分散系）は洗浄液を介して洗い流すことができる（図 6.3）。

78

滅菌ハンドブック

医療機器の洗浄から提供まで

図 6.2：表面張力を下げる乳化剤により水の中で脂肪球と乳濁質が形成される。

図 6.3：表面張力を下げる分散剤により水の中で水不溶性粒子の分散が起こる。

汚れ保持力
汚れ保持力とは、洗浄剤溶液が物質（取り除くべき汚れ）を完全に溶解する（例えばデンプン、タンパク質）
か、乳濁質（脂肪）あるいは分散系（固体）として受け入れる能力である。汚れ保持力は洗浄剤の重要な性質である。よい洗浄結果の達成には、表面から剥がすだけでは足りない。汚れが別の場所に／別の機器に沈殿／堆積（再堆積）しない保証が必要である。
洗浄剤溶液の汚れ保持力は温度により変わる。溶液を冷却すると溶液中に存在する物質が元の不溶性の状態に戻るか、乳濁質及び分散系の安定性が落ちることがある。

6.3 処理用化学薬剤
6.3.1 処理用化学薬剤の種類
医療機器再生には様々な処理用化学薬剤が使われる。本章では、機械（及び用手）洗浄に使われる処
理用化学薬剤をより詳しく扱う（消毒剤については５章で説明した）。
医療機器再生用に、－使われる再生方法によって以下のタイプの処理用化学薬剤が使われる。
●

浸漬槽あるいは超音波洗浄槽での用手予備洗浄用洗浄剤●

浸漬槽あるいは超音波洗浄槽での用手の消毒を伴う予備洗浄用消毒洗浄剤●

機械的再生用洗浄剤

●

中和剤

●

リンス剤

●

機器の手入れ剤▼▼

ブックマーク

機械洗浄用洗浄剤は以下の種類の洗浄剤に分類できる。
●

酸性洗浄剤

●

中性洗浄剤

●

酵素入り中性洗浄剤●

弱アルカリ性洗浄剤●

酵素入り弱アルカリ性洗浄剤●

強アルカリ性洗浄剤

洗浄剤の課題は基本的に、汚れの下に潜り込み、膨張させ、医療機器表面から汚れを剥がすこと、また汚れを乳化させ、洗浄剤溶液中に分散させ、洗浄剤溶液とともに取り除き、医療機器や機械部品の再第6章

医療機器の洗浄と消毒

79

汚染を防ぐことである。水溶性の汚れは直接溶ける、水不溶性の汚れは化学的・物理的反応で溶ける構
成要素に分解され（例えば加水分解により）、乳化されるか、小さく分けられ、分散によって洗浄剤溶液
内で細かく分散され保持される。
洗浄と並んで洗浄剤溶液中の汚れの溶解、乳化及び分散は、適切な洗浄剤の重要な性質であり、これが汚れ保持力と呼ばれる。
酸性洗浄剤
pH 値が低く調整され（pH1 ～ 4）、有機酸あるいは無機酸と界面活性剤をベースにしている。酸性洗浄剤は、特に特別な洗浄の課題、つまり無機質／鉱物質の汚れを取り除くのに使われる。但し、例えば
アルミニウム製、アルマイトをかぶせたアルミニウム製の機器や硬質金属をはめ込んだ機器のような、酸に弱い医療機器の場合、酸性洗浄剤が使えないか、限定的にしか使えないことがある。
中性洗浄剤
主に界面活性剤と洗浄助剤をベースにし、約 pH7 の pH 値に調整されている。中性洗浄剤は特に繊細な医療機器に、低いあるいは中程度の温度範囲（20℃～ 55℃）で使われる。調合によって用途が用手及び／あるいは機械的再生用になる。洗浄剤の作用は特に界面活性剤の性質に基づき、従って調合によってまちまちで、使用可能温度と洗浄メカニズムが限定されている。
酵素入り中性洗浄剤
中性洗浄剤と同様に界面活性剤と洗浄助剤をベースにし、さらに洗浄力を高めるため特にタンパク質分解酵素（プロテアーゼ）を含んでいる。約 pH7 の pH 値に調整され、特に繊細な医療機器に、低いあるいは中程度の温度範囲（20℃～ 55℃）で使われる。調合によって用途が用手及び／あるいは機械的再生用になる。
洗浄作用は使われた界面活性剤の性質と酵素の加水分解（分解）効果に基づく。
弱アルカリ性洗浄剤
アルカリ性物質、界面活性剤及び洗浄助剤を含み、pH 9 ～ 11 の pH 値に調整されている。調合次第
でほとんど全ての医療機器に適しており、中程度の温度範囲（40℃～約 65℃）で、主に機械的再生に使われる。特に界面活性剤とアルカリ性物質の加水分解（分解）によって洗浄効果が達成され、調合次第
では純粋な中性洗浄剤を上回る。
酵素入り弱アルカリ性洗浄剤
弱アルカリ性物質、界面活性剤、洗浄助剤及びこの適用に特に適したタンパク質分解酵素（プロテアー
ゼ）を含んでいる。pH 値は約 pH9 ～ 11 に調整されている。調合によってはほとんど全ての医療機器に適し、中程度の温度範囲（40℃～約 65℃）で主に機械的再生用に使われる。洗浄効果は主に界面活性剤並びにアルカリ性と酵素の加水分解作用によって達成される。様々な洗浄のメカニズムが組み合わされているため、調剤のバランスや洗浄方法の温度管理によっては、この洗浄剤を使って非常によい結果を得ることができる。
強アルカリ性洗浄剤
例えば水酸化カリウム水溶液や水酸化ナトリウム水溶液、水ガラス（ケイ酸ナトリウム、ケイ酸カリウム、
ケイ酸リチウム）のような強アルカリ性物質を含む。通常は使用溶液中の pH 値が pH11 ～ 12 と高い。特に比較的高い温度範囲（55℃～ 93℃）で使われる。洗浄作用は特にアルカリ性の強い加水分解（分解する）

80

滅菌ハンドブック

医療機器の洗浄から提供まで作用に基づいている。この時タンパク質のような有機残渣が分解され、油は鹸化する。形成された分解生成物（例えば脂肪から形成された石鹸）は起泡性で、汚れがひどい場合に従来の洗浄剤を使うと起泡の問題につながることがある。そこで最近の調合の強アルカリ性洗浄剤には、起泡を調整する界面活性剤も含まれている。強アルカリ性洗浄剤は pH 値が高いので、一般に全ての医療機器に適している訳ではない。しかし材料適合性は、適切な腐食防止剤によって改善できる。それでも特にアルカリに弱い材
料の場合個別に考慮される。
浸漬槽あるいは超音波洗浄槽での用手予備洗浄用洗浄剤
その用途を明記することが求められる。この場合、非常に様々な調合が使われる可能性がある。医療機器は通常、予備洗浄後に水ですすぐ必要があるが、これは機械的再生工程で起泡しないためである。
特定の調合でメーカーがそれを明示していれば、機械的再生の前にすすぐ必要がない。
消毒洗浄剤
浸漬槽あるいは超音波洗浄槽内での用手の、消毒をともなう予備洗浄用で、通常は用手再生用の調合である。消毒洗浄剤を医療機器の機械的再生の予備洗浄に使うのは、タンパク質及び他の汚染の医療機
器への固着の可能性がない場合のみにすること。通常はこの製品も予備洗浄後医療機器から水で洗い流し、その後の機械的再生で起泡するのを防ぐ。起泡を少なく調整した特定の調合は、メーカーがそれを明示している場合、機械的再生前にすすぐ必要がない。
中和剤
無機酸あるいは有機酸を含み、アルカリ性（強アルカリ性）洗浄剤での洗浄後に少量をすすぎ水に添加して、残アルカリの中和を確実にする。
リンス剤
少量を最終すすぎ水に添加し、すすぎの対象への水分の付着を最小限にし、それによって乾燥を改善
し、乾燥時間を顕著に短縮する。リンス剤は医療機器に一部残るので、生物学的に問題のないことが保証されている必要がある（生体適合性）。
機器の手入れ剤
外科機器すべり面、例えば鉗子や剪刀の連結面の手入れに使われる。この薬剤は擦過腐食と「かじり」を防ぐのを助ける。機器の手入れ剤は例えば医療用パラフィン油と特殊な乳化剤でできており、乳化剤
は手入れ剤が蒸気を通すようにする。使われた機器手入れ剤は、その後の滅菌方法に適したものである
必要がある。
6.3.2 内容物質とその機能
アルカリ性物質は（例えば水酸化カリウム水溶液（KOH）、水酸化ナトリウム（NaOH））は強アルカリ性の反応をする物質（pH 値が高い）で、水溶液の形で特に温度が高くなると様々な汚れ（タンパク質、天然の脂）を加水分解できる。この時汚れは、小さい、大抵水溶性の構成要素に分解される。アルカリ性
物質はアルカリ性洗浄剤に使われている。
ケイ酸塩
水溶性のケイ酸ナトリウム、ケイ酸カリウム（例えばメタケイ酸ナトリウム）はアルカリ性の洗浄剤