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1、取栓器设计验证测试方案Design Verification Test Protocol forThrombus Retriever肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃
2、袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁
3、袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂
4、蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂
5、薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀
6、蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁
7、薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂
8、蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀
9、蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀
10、蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁
11、螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿
12、螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿
13、袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀
14、衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈
15、蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈
16、薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃聿薆蒅罿羅薅薈螂芃薄螀羇艿薃袂袀膅薂薂肅肁薂蚄袈莀薁螆肄芆蚀衿袇膂虿薈肂肈芅蚁袅羄芅袃肀莃芄薃羃艿芃蚅腿膅节螇羁肁芁袀螄荿芀蕿羀芅莀蚂螃膁荿螄羈肇莈蒄螁肃莇蚆肆莂莆螈衿芈莅袀肅膄莄薀袇肀莄蚂肃羆蒃螅袆芄蒂蒄肁膀蒁薇袄膆蒀蝿腿肂葿袁羂莁蒈薁螅芇蒈蚃羁膃蒇螆螃蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆
17、膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄
18、芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅
19、芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃
20、芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃
21、莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄
22、莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂
23、莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃
24、蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅芁薈螀肄莃莁蚆膃肃薆薂膂膅荿袁膁芇薄袇膁蒀莇螃膀腿蚃虿腿节蒆羇膈莄蚁袃膇蒆蒄蝿芆膆虿蚅袃芈蒂薁袂莀蚈羀袁膀蒀袆袀节螆螂衿莅蕿蚈衿蒇莂羇袈膇薇袃羇艿莀蝿羆莁薅蚅羅肁莈薀羄芃薄罿羃莆蒆袅羃蒈蚂螁羂膇蒅蚇羁芀蚀薃肀莂蒃袂聿肂蚈螈肈膄蒁蚄肇莆螇蚀肇葿薀羈肆膈莂袄肅 文件更改号更改申请人更改后版本日 期X12013-05-091.0 Purpose 目的The purpose of this protocol is to establish a test method and acceptance criteria to verif
25、y the design of thrombus retriever. Through testing all of the samples whether comply with the enterprise standard, to approve the design rationality of product characteristics.该方案的目的是建立取栓器验证设计的测试方法和接收标准。通过测试样品是否满足企业标准的要求来验证取栓器产品设计是否合理。2.0 Scope 范围This protocol just covers the retriever shaped secti
26、on samples manufactured by Laserage and the assembled finish product thereout.该方案仅覆盖由Laserage加工的取栓网架及由此组装的取栓器成品。3.0 User Needs用户需求根据DDD1001000取栓器设计描述文件中对于用户需求中关于功能要求、性能要求和可靠性要求等方面的规定来制定本验证测试方案。Catalog 项目User Need 用户需求Design Input 设计要求1. 功能要求功能需求定义了产品的性质和用途产品尺寸：取栓网架正常状态下的直径应能适合血管的内径根据血管直径设计取栓网架标准直径，分
27、别涵盖3,4,5,6mm的血管直径取栓网架自膨胀后的长度应能包含血栓的整体根据血栓长度，将取栓网架可用长度设计成15-30mm 等几个规格取栓网架压缩状态下的直径应能放入输送导管内取栓网架压缩后的直径小于0.017”或0.021”取栓器应能将血栓顺利取出取栓网架的网孔尺寸设计成适中取栓网架远端应封闭，使用过程中应不使血栓碎块逃逸整个产品的长度应能使取栓网架到达病灶区产品整体长度设计成180cm以上取栓器应具有推送性能推送金属丝具有一定的支撑力，近端直径设计成0.4mm取栓器应能抗折推送金属丝具有一定强度，远端直径设计成渐变推送金属丝采用镍钛丝等不易折弯的材料2. 性能要求性能要求指定多少或有设
28、备必须履行它的功能。取栓网架应能轻易通过弯曲的血管设计采用0.02-0.1mm直径的镍钛丝或以上壁厚的镍钛管以增加柔顺性取栓网架在取栓过程中应对血管壁产生尽可能小的损伤设计对取栓网架进行电解抛光，去除毛刺设计对取栓网架表面涂覆亲水涂层，减少对血管壁的磨损设计取栓网架的径向支撑力应适中取栓网架在X光下应能清晰的显影取栓网架远端和近端设计3-4个铂金金属环取栓网架推出微导管后应能自膨胀采用超弹性材料镍钛合金制作取栓网架外观要求：产品应整洁，无污渍应在进货检验或半成品检验中加入外观检验要求金属件表面应无锈蚀痕迹金属材料均采用镍钛，不锈钢等材料要求：材料应满足生物相容性要求取栓网架采用镍钛合金推送金属
29、丝设计采用镍钛合金盘管设计采用PE材料显影环设计采用铂金材料保护套设计采用PTFE材料运动要求：取栓器使用时在微导管内前后运动应灵活取栓器尺寸应与微导管匹配取栓器应与其他公司的微导管尺寸匹配，在其中运动应无阻力7. 可靠性要求取栓器产品在使用过程中不允许失效，也不允许遗落任何异物在人体血管内取栓支架与远端显影弹簧圈的连接力需大于3N取栓支架与近端显影环的连接力需大于3N推送金属丝与近端显影环的连接力需大于3N支撑弹簧圈与推送金属丝的连接力应大于3N支架本身镍钛丝的连接力强度需满足企业标准要求应能承受极限工作条件而不断裂4.0 Reference Documents参考文献Listed belo
30、w are the supporting documents applicable to the preparation of this protocol, as well as procedures to follow during execution of the protocol.Q/TFOV 5-2013 Enterprise Standard of Presgo Thrombus retrieverDDD1001000 Design Description Document for Thrombus retrieverFMEA1001000 Failure Mode and Effe
31、ct Analysis for Thrombus retrieverPPL1001000 Instructions for Use of Thrombus retrieverLHR Lot History Record of Thrombus retrieverMPI1001001 Flow Chart for Thrombus Retriever5.0 Acceptance Criteria接收标准All samples for this verification test should meet the predetermined specifications and the requir
32、ement specified in the enterprise standard.本次测试方案的所有样品应满足预设的规格及企标中指定的要求。6.0 Material & Equipment物料设备Scale卷尺Micro caliper 千分尺Tensile test machine 拉力测试机Micro catheter 微导管0.017”Simulation aneurysm model 动脉瘤模型7.0 Samples to be tested 测试样品规格The specification tested in this verification is FG1001800-0420,
33、 the detailed information is shown as below: the retriever shaped section is open, the diameter is 4mm and the effective length is 20mm, the total length of thrombus retriever is 180cm.本次测试的样品规格为FG1001800-0420，表示取栓网架为远端开放式的，取栓网架的直径为4mm，可用长度为20mm，取栓器的整体长度为180cmThe samples used in this test are the mo
34、st representative product; the diameter and effective length of retriever shaped section are the median among the whole specifications.此次的测试样品为最具代表性的规格，其取栓网架的直径和可用长度均为整个规格的中值。Refer to the requirement of Flow chart MPI1001000 and Lot history record to make the samples, and test after sterilization.按取
35、栓器流程图草案MPI1001001和LHR草案的规定制作此次样品，经灭菌后用于本次测试。8.0 Verification Test Processing验证测试方法This verification test protocol will include following contents:本测试方案包含以下内容8.1 Physical dimension measurement of retriever shaped section and other components取栓网架和其他部件的物理尺寸测量The purpose of this test is to ensure that t
36、he dimension of the samples comply with the enterprise standard or the predetermined specifications. The testing items and criteria refer to the Figure 1 & table 1本项测试的目的是为了确认样品的尺寸是否满足企业标准和预设的规格的要求，测试项目和接收标准参见图1和表1 Fig. 1 Presgo Thrombus RetrieverTable 1 Dimension test items and acceptance criteriaD
37、imension test itemsAcceptance criteriaTotal length of Thrombus Retriever (L1)18010cmTotal length of Retriever shaped section (L2)322mmEffective length of Retriever shaped section (L3)202mmStruts width of Retriever shaped section (L4)0.0550.01mmDistance from proximal marker to detachment zone (L5)311
38、mmDetachment zone (L6)0.30.1mmOuter diameter of Retriever shaped section D1)4.00.5mmInternal diameter of Retriever shaped section (D2)3.80.5mmOuter diameter of Push wire (D3)0.40.05mmOuter diameter of proximal marker (D4)0.0155Note: The inspection method of the Retriever shaped section dimension sha
39、ll be complied with the requirement as below:注：取栓网架的尺寸测量方法应满足以下要求：Use non-contact measuring equipment which resolution is 0.1mm or more higher to inspect the dimension of the Retriever shaped section as listed in table 1: the dimension of L2, L3, L4, L5, L6, D1, D2 and D4. Inspector shall measure bo
40、th sides and middle of the Retriever shaped section and in two directions perpendicular to each other, each dimension shall be measured 3 times and take the average.通过分辨率达0.1mm或更高的非接触性仪器测量取栓网架表1中所列的如下尺寸：L2, L3, L4, L5, L6, D1, D2 和 D4。测量时，应选择取栓网架的两端及中部，并在相互垂直的两个方向上测量，每个值应测量3次，并取其平均值。8.2 Visual inspe
41、ction 外观检测The purpose of this test is to observe the surface of the components of Thrombus Retriever to meet the enterprise standard. The testing items and criteria refer to table 2本项测试的目的是观察取栓器各部件的外观是否满足企业标准的要求，测试项目和接收标准参见表2Table 2 Visual inspection items and acceptance criteriaTest itemsAcceptance
42、 criteriaAppearance of Retriever shaped section取栓网架内外表面无毛刺，无焦痕，连接处无断裂 No burrs and scorch on inside and outside surface, no disrupt at jointAppearance of metal components各金属件表面无油污、锈迹等 No grease and rust on surface of metal componentsAppearance of plastic components各塑料件表面应透明并无黑点等异物 No black spot and
43、any foreign bodies on surface of plastic components8.3 Flexibility 柔顺性The purpose of this test is to verify the flexibility of the delivery system and the performance when the thrombus retriever going through the curved vessel.本项测试的目的是考察输送系统和取栓器介入手术时在血管内的弯曲能力，通过弯曲血管结构的能力。Curve the 0.017” Micro cathe
44、ter to six tangent circles, each circle diameter is 50mm, and connect the rotating hemostatic valve to Luer lock connector of Micro catheter. Push forward the thrombus retriever into Micro catheter, and it can pass through Micro catheter smoothly, or the maximum resistance force should be similar to
45、 the competitors. The acceptance criteria refer to Table 3.将0.017”的微导管弯曲成6个相切的直径为50mm的圆圈，在微导管鲁尔接头上连接旋转止血阀，导入取栓器样品，应能顺利通过微导管。其最大推送力应和竞争对手产品的相差不大，接收标准见表3Table 3 Flexibility of delivery into Micro catheterTest itemsAcceptance criteria取栓器在通过弯曲的微导管时的最大阻力 Maximum resistance force when the Thrombus retriev
46、er going through the curved Micro catheter取栓器推进过程中应无阻力或与竞争对手产品的相差不大 Feel small resistance force during delivery thrombus retriever or the force is similar to the competitors8.4 Recoil ratio 回缩率The purpose of this test is to verify the performance of adherence to the vessel wall.本测试项目的目的是考察取栓网架的贴壁性。M
47、easure the diameter (D before) of retriever shaped section before withdraw it into the Protective tube, and after place three days stretch it out of the Protective tube, then measure the diameter (D after) again, the measurement method refer to 7.1; After that, calculate the recoil ratio refer to th
48、e following formulaRecoil Ratio（%）= (D before D after ) / D before X 100%The acceptance criteria refer to Table 4.先测量取栓网架回缩入保护套管前的直径D before，然后将取栓网架缩入保护套管，放置3天后取出再测量其直径Dafter，测量方法参照7.1，计算其前后的变化率。接收标准见表4.Table 4 Recoil ratio before and after in Protective tubeTest itemsAcceptance criteria取栓网架放置在保护套管前后的直径变化The diameter variation of retriever shaped section before and after placement in Protective tube回缩率值小于10%Recoil ratio 10%8.5 Compression force 压缩力The pu