KS P ISO 23328-2-2009 Breathing system filters for anaesthetic and respiratory use－Part 2：Non-filtration aspects《麻醉和呼吸用呼吸系统过滤器 第2部分 非过滤特性》.pdf

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3、P ISO 53561, 1： KS P ISO 53562, 2： KS P ISO 9360 1, / (HMEs) 1： 1 250 mL HMEs KS P IEC 60601 1, ISO 11607, Packaging for terminally sterilized medical devices 3 . KS P ISO 233282 :2009 3.1 BSF 3.2 BSF BSF 3.3 BSF , BSF 3.4 BSF , BSF 3.5 BSF BSF , BSF 3.6 BSF , BSF BSF 4 BSF 4.1 BSF (patient connecti

4、on port) KS P ISO 53561 . 4.2 BSF , KS P ISO 5356 1 KS P ISO 5356 2 15 mm 22 mm . 5 5.1 . ： (232) ：(60 15) % RH ： (9610) kPa 2 KS P ISO 233282 :2009 5.2 1 , KS P ISO 9360 1 6.3 . 1 BSF L/min 15 30 5.3 BSF KS P ISO 93601 6.4 . 6 BSF BSF ISO 11607 . 7 7.1 7.3 7.4 KS P ISO 15223 KS S ISO 7000 . 7.2 BSF

5、 BSF . a) BSF , b) BSF “APG” (KS P IEC 60601 1 ) 7.3 . a) , , b) BSF c) “( )” d) e) , (lot) (batch) f) BSF 7.4 BSF BSF BSF “ ” . 3 KS P ISO 233282 :2009 8 . a) b) / c) 5.2 1 d) mL BSF e) 5.3 mL/min f) , , BSF g) BSF , , , h) , i) j) ISO 233281 k) BSF Luer , 4 KS P ISO 233282 :2009 1 KS P ISO 15223,

6、, 2 KS S ISO 7000, 3 ISO 23328 1, Breathing system filters for anaesthetic and respiratory usePart 1 ： Salt test method to assess filtration performance 5 2： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 23328 2:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Breathing system filters for anaesth c and respiratory useetiPart 2：Non-filtration aspects ICS 11.040.10 Korean Agency for Technology and Standards http:/www.kats.go.kr