ГОСТ РИСО 15197—2015
Библиография
[1] ISO /IEC G uide 99:2007. International vocabulary of m etrology — Basic and general conce pts and associated term s
(VIM )
[2] ISO 5725-1. A ccuracy (trueness and precision) o f m easurem ent m ethods and results — P art 1: G eneral principles
and definitions
[3]ISO 5725-1. A ccuracy (trueness and precision) o f m easurem ent m ethods and results — P art 2: B asic m ethod for the
determ ination o f repeatability and reproducibility o f a standard m easurem ent m ethod
[4) ISO 5725-1. A ccuracy (trueness and precision)
of
m easurem ent m ethods and results — P art 3: Interm ediate m ea
sures o f the precision of a standard m easurem ent m ethod
[5] U S Food and D rug A dm inistration. D raft G uidance for Industry. C linical Investigators and Food and D rug A d m i
nistration S taff — D esign C onsiderations for Pivotal C linical Investigators for M edical D evices. Issued on A ugust
15. 2011. A vailable at http://
w w w .fda
.gov/ M edical D evices/D eviceR egulationand G uidance/G uida neeD ocum ents/
um 265553.htm . A ccessed on 2011-11-26
[6]M o sb y’s M edical D ictionary. Elsevier. E ighth E dition. 2009
[7] E valuation of P recision P erform ance o f Q ualitative M easurem ent M ethods: A pproved G uidance-S econd Edition;
C LS I docum ent E P 5-A 2. W ayne. PA: C linical and Laboratory S tandards Institute: 2004
[8 ]C H A N A.Y.. SW A M IN A TH A N R.. C O C K R A N C .S. Effectiveness o f sodium fluoride as a preservativeof glucose in
blood. C lin C hem /1989, 35 (2) pp. 315— 317
[9] JC T LM database: Laboratory m edicine andm
vitro
diagnostics. D atabase o f higher-order referace m aterials,
m easurem ent m ethods/procedures and services (B ureau international des poids et m easures (B IP M ). S evre
(FR A N C E ). A vailable at http:i7
w w w .bipm .org/jctlm /
. A ccessed o n 2011-02-09
[10) PAR KES et al. A new consensus erro r grid to evaluate the clinical significance o f inaccuracies in the m easurem ent
o f blood glucose. D iabetes C are. 2000, 23 (8) pp. 1143— 1148
[11) M ethod com parison and bias estim ation using patient sam ples; A pproved G uidance-S econd E dition: C LS I docu
m ent EP 9-A 2. W ayne. PA: C linical and Laboratory S tandards Institute; 2002
[12) B LA N D J.M . A LTM A N D .G . S tatisticaL m ethods for assessing agreem ent betw een tw o m ethods o f clinical m easure
m ent. Lancet. 1986. 1, pp.307— 310
[13) Interference Testing in C linical C hem istry: A pproved G uidance-S econd E dition; C LS I docum ent E P 7-A2. W ayne.
PA: C linical and Laboratory S tandards Institute; 2005
[14) S elf-m onitoring o f blood glucose. A m erican D iabetes A ssociation. D iabetes C are. 1994. 17 (1) pp. 81— 86
[15] A m erican D iabetes A ssociation. C onsensus statem ent o n self-m onitonng of blood glucose. D iabetes C are. 1 98 7.10
(1) pp. 9 5 — 99
[16) B O Y D J.C .. B R U N S D.E. Q uality specifications for glucose m eters: assessm ent b y sim ulation m odeling of errors in
insulin dose. C lin C hem . 2 0 0 1 .4 7 pp. 209— 214
[17) B O Y D J.C .. B R U N S D.E. M onte C arlo S im ulation in E stablishing A nalytical Q uality R equirem ents for C linical Labo
ratory Tests: M eeting C linical N eeds. M ethods in E nzym ology. C hapter 16. E lsevier Inc. Vol. 467, 2009
[18) T he D iabetes C ontrol and C o m plications Trial R esearch G roup. The effect o f intensive treatm ent o f diabetes on
the deve lopm ent and progression of long-term com plications in insulin-dependent diabetes m ellitus. The D iabetes
C ontrol and C om plications Trial R esearch G roup (D C C T). N .E ngl.J.M ed. 1993. 329 (14) pp. 977— 986
[19J C ouncil D irective 98/79/E C o f the E uropean P arlam ent and o f the C ouncil mOf 2 7 O ctober 1998 on
in vitro
D iagnos
tic M edical D evices. O fficial Journal o f the E uropean U nion L331, D ecem ber 7. 1998
[20) C h aractenzation and Q ualification of C om m utable R eference M aterials for Laboratory M edicine = First E dition. C LSI
docum ent C 53-A . W ayne. PA: C linical and Laboratory S tandards Institute: 2010
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