1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P 3009 KS P 3009 :2010 2010 12 30 http:/www.kats.go.krKS P 3009:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2010 12 30 2010-0689 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P 3009:2010 i ii 1 1 2 1 3 .1 4 .2 5 3 6 4 7 4 8 .6 8 KS P 3
2、009:2010 ii . . , , . , , . KS P 3009:2010 Intradermal acupuncture needles 1 , , , , . 2 . . ( ) . KS D 3703, KS P ISO 109931, 1: KS P ISO 109935, 5: KS P ISO 109936, 6: KS P ISO 109937, 7: KS P ISO 1099310, 10: KS P ISO 1099311, 11: KS P ISO 1099317, 17: KS P ISO 11135, KS P ISO 117372, 2: 3 . 3.1
3、( 鍼, acupuncture needles) , 3.2 ( 皮內鍼, intradermal acupuncture needles) 3.3 ( 滅菌鍼, sterilized acupuncture needles) KS P 3009:2010 2 3.4 ( 鍼體, body of the needle) ( 1 ) 3.5 ( 鍼炳, handle of the needle) ( 1 ) 3.6 ( 鍼尖, tip of the needle) ( 1 ) 3.7 (primary packaging) 1 3.8 (secondary packaging) , . 4 4
4、.1 1 , . 1 d 1 2 L 1 3 L 2 1 3 2 1 L 2L 1d 1KS P 3009:2010 3 4.2 4.2.1 , (:mm) . 4.2.2 1 ( 1 ). 1 :mm (d 1 ) 0.10 0.10 0.16 0.16 0.25 0.25 0.40 0.40 10 % 4.2.3 2 ( 1 ). 2 :mm (L 2 ) (L 1 ) 5 0.5 5 10 0.8 10 30 1.0 30 80 1.5 80 2.0 2 5 5.1 7.3 , . 5.2 KS D 3703 STS 316, STS 304 . , STS 304 () . KS P
5、3009:2010 4 5.3 , , . 6 6.1 a) 7.1 , . b) , . 6.2 6.2.1 . . 6.2.2 , , , 7.1 . 6.2.3 KS P ISO 1099317 . 6.3 6.3.1 60 . 7.2.1 . 6.3.2 , 7.2.2 . 7 KS P ISO 109931 , , , , . 7.1 a) (X10) , , , . (X20 ) , 30 , , KS P 3009:2010 5 . b) 7.3 , , /, , , , . 7.2 7.2.1 KS P ISO 11135 . KS P ISO 109937 . 7.2.2 ,
6、 KS P ISO 117372 . 7.3 7.3.1 , / () . KS P ISO 10993 5 . 7.3.2 / . . KS P ISO 1099310 . 7.3.3 , / . (, , ) . KS P ISO 1099310 . 7.3.4 , ( ) . KS P ISO 1099310 . 7.3.5 () , / 24 1 . . KS P 3009:2010 6 . (single test) . , (subacute), (subchronic) . . KS P ISO 1099311 . 7.3.6 / 24 10 % ( 90) 1 . , . .
7、KS P ISO 1099311 . 7.3.7 , DNA . KS P ISO 109935 . 7.3.8 . . , . KS P ISO 109936 . , , . 8 8.1 8.1.1 . . . . 8.1.2 . 8.1.3 KS P 3009:2010 7 . a) b) (:mm) c) “” “sterile” d) e) f) ( .) 8.2 8.2.1 , . 8.2.2 . . a) (, , ) b) c) (:mm) d) e) “” “sterile” f) g) h) i) ( .) j) k) (, , ) l) KS P 3009:2010 8 1
8、 WHO Library Cataloguing in Publication Data, WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region 2 , , 3 Yong-Hyun Baek, In-Tae Chung, Sang-Hoon Lee, Jae-Dong Lee, Do-Young Choi, A Study for Biocompatibility of Acupunctures Metal Materials, -Focused on Bio
9、logical Character-, Department of Acupuncture 26(3):201-6. 12 . Nitionl Stailless steel . . 1994 ;17(2):495 13 . . . 1998 ; 15(1):225-34 14 . . . 1995 15 Yamaguchi K, Konishi H, Hara S, Motomura Y, Biocompatibility studies of titanium-based alloy pedical screw and rod system histological aspects. Spine J. 2001 Jul-Aug ;1(4) : 260-8 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P 3009 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Intradermal acupuncture needles ICS 11.040 Korean Agency for Technology and Standards http:/www.kats.go.kr