インダストリーレポート 滅菌前、滅菌後試験データの修正 2015年 4月 Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® 滅菌前、滅菌後のインダストリーサマリーレポートの修正 滅菌前、滅菌後のレポートのバクテリアバリア性データに誤りが発見さ れた レギュラトリーサマリーレポート作成中に発見された 機能的同一性には変わりなし 結果としては移行プロトコル品の方がより優れているという結果 修正表は旭・デュポンのホームページにあります 2 プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 ASTM F 2638 原本 1073B Pre-Sterilization 1059B Post-Sterilization Pre-Sterilization 0.25 0.50 Post-Sterilization Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 1073B Pre-Sterilization 0.25 0.00 -0.25 -0.50 Coated Uncoated Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® 1059B Post-Sterilization Pre-Sterilization Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1073B コート品 パウチ用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1073B コート品 ブリスター用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1073B コート品 硬質トレイ用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1073B パウチ用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1059B コート品 ブリスター用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1059B パウチ用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization プロトコル評価結果：滅菌前、滅菌後のバクテリアバリア性 1059B ブリスター用途 ASTM F 2638 原本 Pre-Sterilization Post-Sterilization 0.25 0.50 Difference in the Means (Test-Control) % pMax Difference in the Means (Test-Control) % pMax 0.50 修正 0.00 -0.25 -0.50 Pre-Sterilization 0.25 0.00 -0.25 -0.50 Dashed line (– – –)=Mean of the difference in the means Test=Transition Protocol Material Control=Current Tyvek ® Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15) ® Post-Sterilization
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