KS P ISO 14408-2009 Tracheal tubes designed for laser surgery－Requirements for marking and accompanying information《设计用于激光手术的气管导管 标记和有关信息要求》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 14408 KS P ISO 14408:2009 2009 12 21 http:/www.kats.go.krKS P ISO 14408:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 12 18 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 14408:2009 i .1 1 1 2 1 3

2、.1 4 2 4.1 2 4.2 .2 4.3 3 4.4 3 5 .3 5.1 .3 5.2 4 5.3 .4 5.4 4 6 KS P ISO 14408:2009 Tracheal tubes designed for laser surgery Requirements for marking and accompanying information 2005 2 ISO 14408, Tracheal tubes designed for laser surgery Requirements for marking and accompanying information , . 1

3、 . 2 . . ( ) . KS B ISO 11990, 3 . 3.1 (tracheal tube) (ISO 4135： 2001) 3.2 (cuff) ISO 4135： 2001 . 3.3 (laser-resistant tracheal tube) KS P ISO 14408:2009 2 . 3.4 (laser-resistant tracheal tube treatment) 3.5 (upper anatomical airway； upper airway) 3.6 (laser-resistant portion) 4 4.1 4.2, 4.3 4.4 K

4、S S ISO 7000 EN 980 . 4.2 4.2.1 , , , , EN 980 . 4.2.2 . a) / b) c) d) ( “ .”) 4.2.3 ( ) . 4.2.4 . 4.2.5 . 4.2.6 , 5.4 . 4.2.7 . 4.2.8 . . . , KS P ISO 14408:2009 3 , . 4.3 . a) b) / c) d) e) f) , g) “ ” “ ” h) , “1 ” i) (mm ) j) (： YYYY MM) k) (： , , ) l) , 4.4 . a) ( ) b) / c) d) e) f) g) “ ” “ ”

5、h) , “1 ” i) (： YYYY MM) j) k) (： , , ) l) , 5 5.1 5.1.1 . 5.1.2 , , KS P ISO 14408:2009 4 5.2 , 5.3 . KS B ISO 11990 . 5.4 5.4.1 KS B ISO 11990 . 5.4.2 ( 1 ), 5.4.2.1 5.4.2.6 . 5.4.2.1 “0.5 mm , (Maximum power settings at which ignition did not occur when tested using a spot size of 0.5 mm)” . 5.4.

6、2.2 0 W 100 W 100 W . 5.4.2.3 0 10 . 10 100 W (16010) % . 5.4.2.4 1 10 . 2 W 20 % 1 10 . 5.4.2.5 / . . 5.4.2.6 . a) b) c) , , KS P ISO 14408:2009 5 1 (0.5 mm , ) , s, W Nd： YAG (1.06 m) CO2 (10.6 m) KTP (0.532 m) Argon (0.5 m) KS P ISO 14408:2009 6 1 ISO 4135： 2001, Anaesthetic and respiratory equip

7、ment Vocabulary 2 ISO 5361(all part), Trached tubes 3 KS S ISO 7000, 4 KS P ISO 10993( ), 5 EN 980, Graphical symbols for use in the labelling of medical devices 6 EN 1041, Information supplied by the manufacturer with medical devices 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 14408:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Tracheal tubes designed for laser surgeryRequirements for marking and accompanying information ICS 11.040.10 Korean Agency for Technology and Standards http:/www.kats.go.kr