KS P ISO 11609-2012 Dentistry－Dentifrices－Requirements test methods and marking《牙科学 牙膏的要求、试验方法和标志》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11609 , KS P ISO 11609:2012 2012 9 14 http:/www.kats.go.krKS P ISO 11609:2012 : ( ) ( ) () ( ) : (ISO/TC106) () () ( ) KS P ISO 11609:2012 : (http:/www.standard.go.kr) ： ：2004 11 2 ：2012 9 14 2012-0418 ： ：(ISO/TC106) ( 02-509-7294) (http:/www.kats.g

2、o.kr). 10 5 , . KS P ISO 11609:2012 i ii . iii 1 1 2 1 3 .1 4 2 4.1 .2 4.2 .2 4.3 pH .2 4.4 .2 4.5 .2 4.6 .3 4.7 3 5 3 5.1 pH 3 5.2 .3 5.3 .3 5.4 3 6 3 7 4 A( ) .5 B( ) 11 C( ) 14 17 KS P ISO 11609:2012 ii . KS P ISO 11609： 2004 . KS P ISO 11609:2012 iii 2010 2 ISO 11609, DentistryDentifricesRequire

3、ments, test methods and marking . KS P ISO 11609:2012 , Dentistry Dentifrices Requirements, test methods and marking 1 , , . , . . , . KS P ISO 74051 KS P ISO 10993 12 . 2 . . ( ) . KS M ISO 3696, KS P ISO 1942, KS X ISO 8601, International Nomenclature of Cosmetic Ingredients (INCI), international

4、Cosmetic Ingredients Dictionary and Handbook1)3 KS P ISO 1942 . 3.1 (dentifrice) 3.2 (toothpaste) , , , , . . 1) . http:/www.ctfa.org/council-bookstore. KS P ISO 11609:2012 2 3.3 (single-unit container) 3.4 (primary container) 4 4.1 4.1.1 C 0.15 % . ( 5 12, 28, 29 ). 4.1.2 300 mg . . 4.2 20 mg/kg .

5、13, 14, 15 , . 4.3 pH 5.1 pH 10.5 . 4.4 17 22 31 38 . 4.5 . A 2.5 B 2 KS P ISO 11609:2012 3 . A 4 B 4 5.2 5.3 . 4.6 5.4 30 . . 4.7 . . 5 5.1 pH 3 (KS M ISO 3696 3 ) pH 10 pH . 5.2 A B . . 23 24 5.3 A B . . 23 24 5.4 (402) , (755) % 3 30 .25 , . 6 (10 mL ) . a) “ ” (3. ) b) KS P ISO 11609:2012 4 c) d

6、) e) (INCI) f) , . mg/g g) (mL) (g) h) , 30 i) 1 000 g/g 6 7 , 5.4 . KS P ISO 11609:2012 5 A ( ) A.1 ADA 26 . A.2 . A.3 A.3.1 (calcium pyrophosphate)2) . (silica)3) 27. BSI 513630 . A.3.2 A.3.2.1 4). . ( 5) . . , . . , . A.3.2.2 Geiger-Mller 2) Odontex, 3030 Campfire Dr., Lawrence, KS 66049, USA . h

7、ttp:/. ISO . 3) (Sident) Evonik, Rodenbacher Chaussee 4, 63457 Hanau Wolfgang, Germany . Arnold.StoreckEVONIK.com. ISO . 4) Sabri Dental Enterprises, Inc., 1404 Brooke Dr., Downers Grove, IL 60515, USA . http:/ . ISO . KS P ISO 11609:2012 6 . Geiger . . (counting) 2 % . 1 1 000 . . A.3.3 A.3.3.1 A.3

8、.3.1.1 . . , . 14 mm, 2 mm . . . A.3.3.1.2 , . A.3.3.1.3 8 , 12 . 4 % . 32P - 1 mCi . . . . . 32P 14.3 4 . A.3.3.1.4 (polymer) . . 2 mm / . / , . . . A.3.3.2 A.3.3.2.1 . . KS P ISO 11609:2012 7 A.3.3.2.2 . . A.3.3.2.3 . . A.3.3.2.4 . 2 mm . A.3.4 5) 10 mm . . , . . , . Chatillon 150 g . . . A.3.5 10

9、 % 0.5 % (7MF CMC)6) . 1 L 50 mL 60 CMC 5 g . , 50 mL 60 . 1 L 900 mL . . . . A.3.6 A.3.1 . 10 g 50 mL (A.3.5). . . 40 % . 25 g 40 mL . 5) Odontex, 3030 Campfire Dr., Lawrence, KS 66049, USA . http:/www.O. ISO . 6) CMC Hercules Incorporated, Aqualon Division, 1111 Hercules Road, Hopewell, VA 23860-2

10、782, USA. http:/ ISO . KS P ISO 11609:2012 8 A.3.7 25 g 40 mL . 8 . . , . A.3.8 A.3.8.1 . . 6 000 , 1 000 . 150 g . . A.3.8.2 , 10 000 , 1 000 . . A.3.9 A.3.9.1 . 1 ( ) , 1 . 2 ( ) . 2 . . . 8 ( ). . 150 g , 1 500 3 000 . A.3.9.2 5 000 7 500 . A.3.10 . . , 3 mL . . . KS P ISO 11609:2012 9 . . . 1 60

11、 . A.3.11 A.3.11.1 . - . . . A.3.11.2 Geiger-Mller ( ) 5 mL . 250 mL . 1.0 mL . 0.5 mol/L NaOH 1.0 mL . . . . A.3.11.3 Cf . Cf4 4 (A.1) A.3.11.3.1 . , (CPM) , . A.3.13 , Cf . A.3.11.3.2 . , . , 0.01 g . A.3.11.3.3 g . . A.3.12 Gerger-Mller A.3.12.1 KS P ISO 11609:2012 10 ( ) . 2 + (A.2) 100fC (A.3)

12、A.3.12.2 ( ) . 2 + (A.4) 10fC (A.5) A.3.13 A.3.13.1 ( ) . 2gg + (A.6) gg 100 (A.7) A.3.13.2 ( ) . g 2gg + (A.8) gg 10 (A.9) KS P ISO 11609:2012 11 B ( ) B.1 BS 5136： 19813 ( A ) . B.2 B.2.1 , 0.1 m Surfometer Surftest SV-20007), , 0.1 m Proscan 20008). B.2.2 Kent 3 9), P1200 (silicon carbide) . ( ).

13、 B.2.3 , A.3.2.1 8 , / n . B.2.4 , A.3.4 B.2.5 , A.3.1 , BSI , BS 513630 . B.3 B.3.1 40 1 . 2 . . 7) Surfometer Planar Products., Sunbury on Thames, UK , Surftest SV-2000 Mitutoyo, Andover, UK . ISO . 8) Proscan 2000 Scantron Industrial products Ltd., Monarch Center, Venture Way, Taunton, UK . ISO . 9) Kent 3 Kermet International Ltd., Maidstone, UK . ISO . KS P ISO 11609:2012 12 B.3.2 ( , ) , 24 (