KS I ISO 17994-2010 Water quality－Criteria for establishing equivalence between microbiological methods《水质 微生物方法之间的等效性建立规则》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS I ISO 17994 KS I ISO 17994 :2010 2010 8 31 http:/www.kats.go.krKS I ISO 17994:2010 : ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2005 12 14 ：2010 8 31 2010-0347 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS I ISO 17994:2010 i .1 1 1 2 1 3 ,

2、.1 4 4 5 4 5.1 .4 5.2 4 5.3 .5 5.4 ()(counting and confirming)8 6 (calculations) 9 6.1 (preliminary editing of the raw data).9 6.2 (the basic relative differences)9 6.3 (the mean relative difference) .9 6.4 (the expanded uncertainty)10 6.5 P/A (P/A methods)10 7 10 7.1 (preliminary evaluations)10 7.2

3、 (two-sided evaluation).11 7.3 (one-sided evaluation) 12 7.4 P/A (two P/A methods) 13 8 .13 A() 14 B() 15 B.1 .15 B.2 (panel)15 B.3 (practical aspects).15 B.4 (the data report sheet) 15 C() .17 19 KS I ISO 17994:2010 Water qualityCriteria for establishing equivalence between microbiological methods

4、2004 1 ISO 17994, Water qualityCriteria for establishing equivalence between microbiological methods , . . . . 1 2 . . ( ) presence/absence(P/A) . ( MPN) (P/A) . 2 . . ( ) . KS I ISO/TR 13843, 3 , 3.1 KS I ISO 17994:2010 2 . 3.1.1 3.1.1.1 (reference method) . 3.1.1.2 (trial method) 3.1.1.3 (equivale

5、nt method) , “ (not different)” 3.1.1.4 (standard uncertainty) GUM 3.1.1.5 (expanded uncertainty) . . . GUM 3.1.1.6 (coverage factor) () (multiplier) k2 . 95 % . 3.1.2 3.1.2.1 (count) , , (bacteriophages) (plaques) MPN . KS I ISO 17994:2010 3 3.1.2.2 (presumptive count) 3.1.2.3 (confirmed count) (fa

6、lse positive) 3.1.2.4 (relative difference) RD () a b RD x . xln(a)ln(b)100 % a b 3 . % 100 ) ( ) ( 2 b a b a x “ (relative difference)” . 3.2 A ( ) a A a i i A ( ) B ( ) b B b i i B ( ) C D A B “ (not different)” () i running k (coverage factor) L A B (, ) MPN m MPN n n AP/A , A B n BP/A , A B P/A

7、/ s ( ) s 2 x s ( ) U x x i i a i b i x x i (i1, 2, , n) KS I ISO 17994:2010 4 x L 95 % , 95 % x H 95 % , 95 % X 2 (Poisson) y / 4 2 () (a ib i ) . . (0) 2 (“not different”) . 7.2 7.3 . A . 1 (D) (L) . 2 D10 % . 3 . ( ) . 5 5.1 KS I ISO 13843 . . . . . B . , . 5.2 . . (0) (zero count) . KS I ISO 179

8、94:2010 5 . . , (spiking) . (spiking) . . 5.3 5.3.1 . . “ ” . “ ” . , . . . ( ), . 5.3.3 5.3.6 . 5.3.2 . 6. . 5.3.3 , 95 % n . nCs 2 s 2 ： C ： C C4/L 2 . D() L( ) LD/2( 1 ). KS I ISO 17994:2010 6 1 (L) D a% L % C 60 30 0.004 4 40 20 0.010 0 30 15 0.017 8 20 10 0.040 0 10 5 0.160 0 a (D) . s80. n6 40

9、0 C . 10 % (L10 %) n6 400 0.040 0256 . 5.3.4 , MPN MPN (n) (m) . n1 700/m 5 1 700/5340 10 % . 5.3.5 , (mixed comparions) MPN ( 5.3.3) ( 5.3.4) . , 2 . . . 5.3.6 , P/A P/A . ( ) ( ) . 95 % L 2 . ( ) ( ) . “ ” . KS I ISO 17994:2010 7 2 P/A L L % n 40 100 30 170 20 380 15 680 10 1 540 5 6 140 5.3.7 P/A

10、 (number of samples when comparing a counting method with a P/A method) . P/A (down-grading) P/A (up-grading) . (down-grading) ( ) . . , P/A (5.3.6). 1 ( ) . P/A P/A MPN (up-grading). , 100 mL 10 mL 10 , MPN 5 mL 20 . MPN (5.3.4) (5.3.5) . 2 P/A MPN (up-grading) . . . . (up-grading) . 5.3.8 (the min

11、imum requirements for verification) . , . . . , . (7.2.4 7.3.5 ) . 30 . KS I ISO 17994:2010 8 2 4 y s n n ： s ： y ： x y 1| | | | 2 D x y D ： % “ ” 0 x：% (7.3) , y 2 D x y 2 x D . . MPN 2 . P/A , 400 ( ) ( ) . 5.4 ()(counting and confirming) 5.4.1 . 2 . 100 mL MPN . 5.4.2 (confirmation) (confirmation

12、) . ( ) . ( B ). , . , 10 30 . . 1：3, 1：2 . . . ( ) . KS I ISO 17994:2010 9 . (conformation rate) . in situ ( ) . , . MPN P/A . 6 (calculations) 6.1 (preliminary editing of the raw data) (0, 0) TNTC, “ (larger than)” . (0, 0) . 6.2 (the basic relative differences) 6.2.1 (regular count data) 0 (a i ,

13、 b i ) . % 100 ) ln( ) ln( i i i b a x 6.2.2 (0) (results with zeroes) (a i , 0) (0, b i )(type) . , . (a i , 0)(type) , . % 100 ) 1 ln( i i a x (0, b i )(type) , . % 100 ) 1 ln( i i b x 1 (1) “ (count)” . , (a i , 0) ( a i 1, 01). 2 (0) . (0) . 75 % (regular count data) . 6.3 (the mean relative dif

14、ference) (average relative performance) % . n x x i n ： KS I ISO 17994:2010 10 x i ： i 6.4 (the expanded uncertainty) x () . 1 ) ( 2 n x x s i ( “ ”) . n s s x k2 . n s ks U x 2 “ ” . (lower limit)： U x x L(upper limit)： U x x H6.5 P/A (P/A methods) P/A . n A A B . n B B A . P/A (X 2 )(sign test) Mc

15、Nemar . . . ) ( ) ( B A 2 B A 2 n n n n X 7 7.1 (preliminary evaluations) 7.1.1 (examination by groups) . (non-parametric) . . , . , KS I ISO 17994:2010 11 . . . . . . 7.1.2 (outlier) , . . ln(b i ) ln(a i ) . . (great random variation) . . , 1 . . 7.2 (two-sided evaluation) 7.2.1 , . , . , (D) (D)

16、. 7.2.2 “ ” (methods “not different”) “ ”. D x L 0 0 x H D 7.2.3 “” (methods “different”) “ ”. x L 0 x H 0 7.2.4 (inconclusive) . x L D x H 0 x L 0 x H D KS I ISO 17994:2010 12 . 5.3.8( C ) . 7.2.5 , (indifferent) () . x LD x H 0 x L 0 x HD ( ) . . 7.3 (one-sided evaluation) 7.3.1 (reference method) 2. (D) . . 7.3.2 “ ” (methods “not different”) “ ”. D x L 0 x H 0 7.3.3 ： (trial method：higher recovery) ( ) . x L 0 . 7.3.4 ： (trial method：lower recovery) () . x H 0 7.3.5 (inconclusive) . x L D x H 0 . 5.3.8(5.3.8 ) .