{"id":2332,"date":"2024-11-26T10:16:36","date_gmt":"2024-11-26T02:16:36","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2332"},"modified":"2026-02-09T09:59:05","modified_gmt":"2026-02-09T01:59:05","slug":"terms-and-definitions-of-eto-gas-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2332","title":{"rendered":"Terms and definitions of eto gas sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-c4886133 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11-1024x1024.webp\" alt=\"\" class=\"uag-image-8477\" width=\"1024\" height=\"576\" title=\"eto-sterilizer-11\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">この文書の目的上、次の用語と定義が適用されます。 <strong>エチレンオキシド滅菌<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/aeration-room\/\">3.1 エアレーション <\/a><\/strong><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-88653b7b wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Aeration-Room-3-300x300.webp\" alt=\"\" class=\"uag-image-8358\" width=\"300\" height=\"300\" title=\"Aeration-Room-3\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">part of the eto gas sterilization process during which ethylene oxide and\/or its<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">反応生成物は、所定のレベルに達するまで医療機器から脱離します。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Note 1 to entry: This can be performed within the sterilizer and\/or in a separate chamber or room.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.2 曝気エリア <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">チャンバーまたはエアレーションが行われる部屋のいずれか<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.3 バイオバーデン <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">population of viable microorganisms on or in product and\/or sterile barrier system<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.2]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.4 生物学的指標 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">特定のエトガス滅菌プロセスに対して定義された耐性を提供する生存微生物を含むテストシステム<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.5 校正 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">指定された条件下で、測定器または測定によって示される量の値間の関係を確立する一連の操作<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">システム、または材料尺度または基準材料によって表される値、および規格によって実現される対応する値<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.6 化学インジケーター <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1 つ以上の事前定義されたプロセス変数の変化を明らかにするテスト システム<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセスへの曝露によって生じる化学的または物理的変化に基づく<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.6]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/precondition-room\/\">3.7 コンディショニング <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エチレンガス滅菌サイクル内でエチレンの前に製品を処理<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">所定の温度と相対湿度を達成するための酸化物の侵入<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: エチレンオキシド滅菌サイクルのこの部分は、大気圧または真空下で実行できます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 2: 3.27「事前調整」を参照<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.8 <\/strong><strong><em><strong><em>D <\/em><\/strong><\/em><\/strong><strong>価値 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>D<\/em>10 <strong>価値 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">規定の条件下で試験微生物集団の90%を不活化するのに必要な時間または用量<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.11] ?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: この国際規格の目的上、 <em>D <\/em>値は、試験微生物の集団の 90 % の不活化を達成するのに必要な曝露時間です。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.9 開発 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">仕様を詳しく説明する行為<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.13]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.10露点 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">飽和水蒸気圧が等しくなる温度。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">大気中の水蒸気の分圧<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: 大気を露点以下に冷却すると、水が凝縮する可能性があります。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.11 確立 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">理論的評価によって決定し、実験によって確認する<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.17]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">9ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/zjbocon.com\/product\/eto-sterilzer\/\"><strong>3.12 エチレンオキシド（EO）注入時間<\/strong>&nbsp;<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">チャンバーへの EO (混合物) の最初の導入から始まり、その注入が完了するまでの段階の期間<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.13 露光時間 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセスパラメータが指定された許容範囲内に維持される期間<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.18]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: サイクル致死率の計算では、EO 注入の終了と EO 除去の開始の間のエチレンオキシド滅菌の期間を指します。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.14 故障 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">one or more of the process parameters lying outside of its\/their specified<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">公差<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.19]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.15 フラッシング <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エチレンオキシドを負荷およびチャンバーから除去する手順<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">濾過された空気、不活性ガス、または蒸気の複数回の交互の導入とチャンバーの排気、または濾過された空気、不活性 10ISO 11135-2014 ガスまたは蒸気の負荷とチャンバーへの連続通過のいずれかによって行われます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.16 分数サイクル <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">従来に比べて EO ガスへの曝露時間を短縮したサイクル<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エチレンオキシド滅菌工程で指定<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.17 半サイクル <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エチレンオキシド滅菌プロセスで規定されている時間と比較して、EO ガスへの曝露時間が 50 % 短縮されるサイクル<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.18 医療施設 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">を専門とする政府および民間の組織および機関<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">健康の増進と維持、病気の予防と治療<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">病気や怪我<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">例 医療施設には、病院、老人ホーム、延長介護施設、独立型外科センター、診療所、診療所、または歯科医院が含まれます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.19 ヘルスケア製品 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">医療機器（以下を含む） <em>インビトロ <\/em>診断用医療機器、またはバイオ医薬品を含む医薬品<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">11 ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.20]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">3.20 設置資格 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">機器が提供されたという証拠を入手して文書化するプロセス<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">仕様に従って設置されています<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.22]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.21 医療機器 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">あらゆる器具、装置、用具、機械、器具、インプラント、 <em>インビトロ <\/em>試薬またはキャリブレーター、ソフトウェア、材料、または関連物品で、人間に対して 1 つまたは複数の特定の目的で単独または組み合わせて使用​​することをメーカーが意図したもの。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 diagnosis, prevention, monitoring, treatment or alleviation of disease,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 investigation, replacement or modification or support of the anatomy or of a physiological process,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 control of conception,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 disinfection of medical devices,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2014 providing information for medical purposes by means of <em>インビトロ <\/em>人体由来の検体の検査で、薬理学的、免疫学的、または代謝的手段によって人体内または人体上で主に意図された作用を達成しないが、そのような手段によってその機能が補助される可能性のある検体の検査<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[出典: ISO 13485:2003、定義 3.7]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.22 微生物 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">細菌、真菌、原生動物、ウイルスを含む顕微鏡サイズの実体<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: 特定の規格では、<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">あらゆる種類の微生物を不活化するエトガス滅菌プロセスの有効性<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">microorganisms, identified in the definition above, for validation and\/or<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エトガス滅菌プロセスの日常的な制御。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">3.23 運用資格 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">機器が設置された証拠を入手して文書化するプロセス<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">に従って使用すると、所定の制限内で動作します。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">操作手順<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.27]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.24 過剰なアプローチ<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">最低 12 個の胞子ログを提供する eto ガス滅菌プロセスを使用したアプローチ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">製品バイオバーデン以上の耐性を持つ生物学的指標への削減（SLR）<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.25パラメトリックリリース <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセスパラメータが指定された許容範囲内で提供されたことを示す記録に基づいて、製品が無菌であることを宣言する<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.29]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: このプロセスリリース方法には、生物学的指標の使用は含まれません。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">3.26 パフォーマンス認定 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">操作手順に従って設置および操作された機器が、所定の基準に従って一貫して動作し、それによって仕様を満たす製品が得られるという証拠を取得および文書化するプロセス<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.30]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-process\/\">3.27 事前調整 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エトガス滅菌サイクルの前に、指定された温度と相対湿度の条件を達成するために部屋またはチャンバー内で製品を処理すること<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.28 プロセスチャレンジデバイス <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">アエトガス滅菌プロセスに対する定義された耐性を構成するように設計され、プロセスのパフォーマンスを評価するために使用されるアイテム<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.33]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: この国際規格の目的のために、PCD は次のようにすることができます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">製品、模擬製品、または直接接種されるその他のデバイスであるか、<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">間接的に。 7.1.6 および D.7.1.6 を参照してください。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 2: この国際規格では、内部 PCD と外部 PCD が区別される。内部 PCD は、必要な製品 SAL が達成されていることを実証するために使用されます。製品または製品の輸送用ケースの範囲内に位置する PCD は内部 PCD であり、一方、輸送用ケースの間または積荷の外面に位置する PCD は外部 PCD です。外部 PCD は微生物検査に使用するように設計されたアイテムです。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">日常的な生産サイクルの監視。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.29 プロセスパラメータ <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセス変数の指定値<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: eto ガス滅菌プロセスの仕様には、<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセスパラメータとその許容誤差。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.34]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.30 プロセス変数 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">エチレンオキシド滅菌プロセス内の状態、殺菌効果を変える変化<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">例?時間、温度、圧力、濃度、湿度、波長。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.35]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.31 処理カテゴリー <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">滅菌可能なさまざまな製品または製品ファミリーのコレクション<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">一緒に<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: カテゴリ内のすべての製品は、エチレンオキシド滅菌プロセスに対して、そのグループのプロセスチャレンジデバイスと同等以下のチャレンジを示すと判断されています。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.32 製品 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセスの結果<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[出典: ISO 9000:2005、定義 3.4.2]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: エチレンオキシド滅菌基準の目的上、製品は<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">有形であり、原材料、中間体、サブアセンブリ、および<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ヘルスケア製品。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.33 製品ファミリー <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">滅菌可能な特性を備えた製品群<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">定義されたプロセス条件を使用する<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.34 製品積載量<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">製品が占める使用可能なチャンバー容積内の規定のスペース<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.35 認定された文化コレクション <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ブダペスト条約に基づく寄託機関 <em>インターナショナル<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>寄託金の認識<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>特許および規制を目的とした微生物<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.38]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.36 参照微生物 <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">認められた培養コレクションから得られた微生物株<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.37 再資格認定 <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">指定されたプロセスが継続的に受け入れられることを確認する目的で検証の一部を繰り返すこと<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.38 再利用可能な医療機器 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">メーカーが以下に適していると指定または意図した医療機器。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">再処理と再利用<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: これは、指定または意図された医療機器ではありません。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">メーカーは単回使用のみを目的としています。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.39 サービス <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">機器が正しく機能するために必要な外部ソースからの供給<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">例 電気、水道、圧縮空気、排水。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.41]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.40 単回使用医療機器 <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">メーカーが1回限りの使用を指定または意図した医療機器<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.41 指定する <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">承認された文書内で詳細に規定する<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.42 胞子ログの削減 <\/strong>初期胞子数のログ、 <em>N<\/em>0、最終母集団の対数を引いたもの、 <em>N<\/em>あなた<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[出典: ISO 14161:2009、定義 3.19]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: 細胞上の胞子数の減少について説明する。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">特定の物質への曝露によって生成される生物学的指標または接種物品<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">条件。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">直接列挙の場合:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SLR = ログ <em>N<\/em>0 ログ？ <em>N<\/em>あなた<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">どこ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 は初期母集団です。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>u は最終母集団です。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">フラクションネガティブの場合:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SLR = ログ <em>N<\/em>0 \u2013 log [ln (<em>q<\/em>\/<em>n<\/em>)]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">どこ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>N<\/em>0 は初期母集団です。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>q <\/em>テストされた反復サンプルの数です。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>n <\/em>は、成長にとってマイナスとなるサンプルの数です。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">生存者がいない場合、真の SLR は計算できません。一眼レフカメラは、<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">reported as \u201cgreater than\u201d log <em>N<\/em>0 1 つの生き残った微生物が使用された場合。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.43 無菌 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">生存可能な微生物を含まない<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.43]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.44 無菌バリアシステム<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">微生物の侵入を防ぎ、無菌化を可能にする最小限のパッケージ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">使用時の製品のプレゼンテーション<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.44]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.45 無菌性<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">生存微生物がいない状態<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: 実際には、微生物が存在しないという絶対的な言明は証明できません。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 2: 3.47「滅菌」を参照。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.45]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.46 無菌保証レベル <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">後にアイテム上に単一の生存微生物が発生する確率<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">殺菌<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: SAL という用語は、一般に 10-6 または 10-3 という定量的な値をとります。この定量的値を無菌性の保証に適用すると、SAL 10-6 は値が低くなりますが、SAL 10-3 よりも高い無菌性保証が得られます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.46]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/product\/eto-sterilzer\/\">3.47 滅菌 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">製品に生存微生物を含まないようにするために使用される検証済みのプロセス<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: 滅菌プロセスでは、微生物の性質<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">不活化は指数関数的であるため、個々の品目での微生物の生存は確率で表すことができます。この間に<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">確率は非常に低い数値に減らすことができますが、ゼロに減らすことはできません。 ISO 11135-2014<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 2: 3.46、無菌保証レベルを参照。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.47]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-cycle\/\">3.48 滅菌サイクル <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air\/inert gas admission<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.49 滅菌負荷 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">特定の薬剤を使用して一緒に滅菌される、または滅菌された製品<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">滅菌プロセス<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.48]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-process\/\">3.50 滅菌工程 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">指定された無菌要件を達成するために必要な一連のアクションまたは操作<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.49]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: この一連のアクションまたは操作には、前提条件が含まれます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">（必要な場合）、規定の条件下でのエチレンオキシドへの曝露、およびエチレンオキシドとその副生成物の除去に必要な後処理。滅菌プロセスに先立つ洗浄、消毒、または包装作業は含まれません。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.51 滅菌専門医 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">使用されている滅菌技術と、その滅菌技術が材料や微生物に及ぼす影響についての技術的知識を有する人<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.52 殺菌剤 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">規定の条件下で無菌性を達成するのに十分な殺菌活性を有する物質の生成<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.50]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.53生存者曲線 <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">規定の条件下で殺菌剤への曝露が増加することによる微生物集団の不活化のグラフ表示<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.51]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.54 無菌性テスト <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">滅菌プロセスにさらされた後に製品に対して実行される薬局方で定義された技術的操作<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.53]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.55 無菌性試験 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">開発、検証、または<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">製品またはその一部に生存微生物が存在するか否かを判断するための再認定<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.54]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.56 使用可能なチャンバー容積 <\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">固定部品や可動部品によって制限されず、滅菌負荷を受け入れることができる、滅菌室内の定義されたスペース<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">注記 1: 内部の負荷の周囲にガスが循環するために許容される容積<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">チャンバーは使用可能なスペースとして含まれません。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">3.57 検証 <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">プロセスが所定の仕様に準拠した製品を一貫して生成することを確立するために必要な結果を取得、記録、解釈するための文書化された手順<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">[SOURCE: ISO\/TS 11139:2006, definition 2.55]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3.58 バージンマテリアル <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">以前に使用されていない、または元の製造以外の加工が施された素材<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">エチレンオキサイド滅菌について詳しく知りたい場合<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">電話：<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">電子メール:<a href=\"mailto:hayley@hzbocon.com\">ヘイリー@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ローカルサイト: 中国浙江省杭州市下沙区財通中新1202号室<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Webサイト：<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">&nbsp;zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>この文書の目的上、次の用語と定義がエチレンオキシド滅菌に適用されます。 3.1 [ の曝気部分]&hellip;】<\/p>\n","protected":false},"author":234312599,"featured_media":8477,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":false,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2332","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - 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provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization validation","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=700%2C400 2x"},"classes":[]},{"id":2554,"url":"https:\/\/zjbocon.com\/?p=2554","url_meta":{"origin":2332,"position":4},"title":"30 m\u00b3 eto gas sterilizer","author":"Bocon Technical Team","date":"2024-12-31","format":false,"excerpt":"The 30 m\u00b3 eto gas sterilizer consists of the sterilizer housing, auxiliary equipment (heating and thermal cycling device, vacuum extraction device, dosing and vaporization device, humidification device, sealing device, residual gas processing device), and monitoring and control device.","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1 1x, 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sterilization goods, follow the closing procedure for the discharge door, and inflate the sealing gasket of the discharge door until the pressure reaches above 0.45 MPa to ensure a proper seal. 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