1 ISO 17665.1 医疗器械灭菌过程的开发、验证和常规控制要求 2006（英文版）.pdf

EN ISO 17665-1:2006 INTERNATIONAL ISO STANDARD 17665-1 First edition 2006-08-15 Sterilization of health care products — Moist heat — Part 1: Requirements forthe development, validation and routine controlof a sterilization process for medical devices Stérilisationdes produits desanté— Chaleurhumide— Partie 1:Exigences pourledéveloppement,lavalidationet le contrôlede routinedun procédédestérilisationdes dispositifs médicaux Reference number ISO 17665-1:2006(E) EN ISO 17665-1:2006 Contents Page Forewordv Introduction .vi 1 Scope .. 1 1.1 Inclusions . 1 1.2 Exclusions ... 1 2 Normative references ...2 3 Termsanddefinitions ...3 4 Quality managementsystemelements .. 10 4.1 Documentation ... 10 4.2 Management responsibility ... 10 4.3 Product realization ... 10 4.4 Measurement,analysis and improvement— Controlof non-conforming product ... 10 5 Sterilizing agent characterization .. 11 5.1 Sterilizing agent . 11 5.2 Microbicidaleffectiveness .. 11 5.3 Materials effects . 11 5.4 Environmentalconsideration ... 11 6 Processand equipment characterization . 11 6.1