ГОСТ Р ИСО 23500-3-2021. Национальный стандарт Российской Федерации. Подготовка жидкостей для гемодиализа и сопутствующей терапии и менеджмент качества. Часть 3. Вода для гемодиализа и сопутствующей терапии
БИБЛИОГРАФИЯ
[1] | ISO 17294-2:2016, Water quality - Application of inductively coupled plasma mass spectrometry (ICP-MS) - Part 2: Determination of selected elements including uranium isotopes |
[2] | ISO 10304-1:2007, Water quality - Determination of dissolved anions by liquid chromatography of ions - Part 1: Determination of bromide, chloride, fluoride, nitrate, nitrite, phosphate and sulfate |
[3] | ISO 10359-1:1992, Water quality - Determination of fluoride - Part 1: Electrochemical probe method for potable and lightly polluted water |
[4] | RICE E.W., BAIRD A.B., EATON A.D. Standard Methods for the Examination of Water and Wastewater. 23rd Edition, American Public Health Association, American Water Works Association, Water Environment Federation. 2017 |
[5] | U.S. Environmental Protection Agency. Methods for the determination of metals in environmental samples, Supplement 1 (EPA-600-R-94-111). Cincinnati (Ohio): Environmental Monitoring Systems Laboratory |
[6] | U.S. Environmental Protection Agency. National Primary and Secondary Drinking Water Regulations. U.S. Environmental Protection Agency |
[7] | World Health Organization. Guidelines for drinking-water quality. Geneva, Fourth Edition, 2011. Available on line at: http://www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/ |
[8] | MALTAIS J.B., MEYER K.B., FOSTER M.C. Comparison of techniques for culture of dialysis water and fluid. Hemodial Int. 2017, 21 pp. 197 - 205 |
[9] | LEDEBO I., NYSTRAND R. Defining the microbiological quality of dialysis fluid. Artif Organs. 1999, 23(1) pp. 37 - 43 |
[10] | PASS T., WRIGHT R., SHARP B., HARDING G.B. Culture of dialysis fluids on nutrient-rich media for short periods at elevated temperatures underestimate microbial contamination. Blood Purif 1996, 14 (2) pp. 136 - 45 |
[11] | NYSTRAND R. Standards and standardisation of detection methods for bacteria endotoxin in water and dialysis fluid Nieren- und Hochdruckkrankheiten 1999, 28 pp. 43 - 48 |
[12] | REASONER D.J., Geldreich E.E. A new medium for the enumeration and subculture of bacteria from potable water. Appl Environ Microbiol. 1985, 49(1) pp. 1 - 7 |
[13] | VAN DER LINDE K., LIM B.T., RONDEEL J.M., ANTONISSEN L.P., DE JONG G.M. Improved bacteriological surveillance of haemodialysis fluids: a comparison between Tryptic soy agar and Reasoner's 2A media. Nephrol Dial Transplant. 1999, 14 (10) pp. 2433 - 7 |
[14] | WESTRICK J.A., SZLAG D.C., SOUTHWELL B.J., SINCLAIR J. A review of cyanobacteria and cyanotoxins removal/inactivation in drinking water treatment. Anal Bioanal Chem. 2010, 397(5) pp. 1705 - 14 |
[15] | MEREL S., WALKER D., CHICANA R., SNYDER S., |
[16] | Centers for Disease Control (CDC). Fluoride intoxication in a dialysis unit - Maryland. Morbidity and Mortality Weekly. 1980, 29 pp. 134 |
[17] | ARNOW P.M., BLAND L.A., GARCIA-HOUCHINS S., FRIDKIN S., FELLNER S.K. An outbreak of fatal fluoride intoxication in a long-term hemodialysis unit. Ann. Intern. Med. 1994, 121 (5) pp. 339 - 344 |
[18] | ALFREY A.C., LEGENDRE G.R., KAEHNY W.D. The dialysis encephalopathy syndrome. Possible aluminum intoxication. N Engl J Med 1976, 294(4) pp. 184 |
[19] | PARKINSON I.S., WARD M.K., KERR D.N. Dialysis encephalopathy, bone disease and anaemia: the aluminum intoxication syndrome during regular haemodialysis. J Clin Pathol 1981, 34 (11) pp. 1285 |
[20] | KOVALCHIK M.T., KAEHNY W.D., HEGG A.P., JACKSON J.T., AFREY A.C. Aluminum kinetics during hemodialysis. J. Lab. Clin. Med. 1978, 92(5) pp. 712 - 720 |
[21] | MASUYAMA J.T.Y. Effects of water purification on renal osteodystrophy in the patients with regular hemodialysis therapy, J. Japan. Soc. Kidney Dis. 1984, 26 pp. 407 - 416 |
[22] | SIMOES J., BARATA J.D., D'HAESE P.C., DE BROE M.E. Cela n'arrive qu'aux autres (aluminium intoxication only happens in the other nephrologist's dialysis centre). Nephrol Dial Transplant 1994, 9 (1) pp. 67 - 8 |
[23] | BEREND K., VAN DER VOET G., BOER W.H. Acute aluminum encephalopathy in a dialysis center caused by a cement mortar water distribution pipe. Kidney Int 2001; 59:746 |
[24] | CHOWDHURY S., RODRGUEZ M.J., SADIQ R. Disinfection byproducts in Canadian provinces: associated cancer risks and medical expenses. J Hazard Mater 2011, 187 (1 - 3) pp. 574 - 584 |
[25] | EATON J.W., KOPLIN C.F., SWOFFORD H.S., KJELLSTRAND C.M., JACOB H.S. Chlorinated urban water: A cause of dialysis-induced hemolytic anemia. Science. 1973; 181 (4098), pp. 463 - 464 |
[26] | FLUCK S., MCKANE W., CAIRNS T., FAIRCHILD V., LAWRENCE A., LEE J., MURRAY D., POLPITIYE M., PALMER A., TAUBE D. Chloramine-induced haemolysis presenting as erythropoietin resistance. Nephrol. Dial. Transplant. 1999, 14(7) pp. 1687 - 1691 |
[27] | DE TORRES J.P., STROM J.A., JABER B.L., HENDRA K.P. Hemodialysis-associated methemoglobinemia in acute renal failure. Am. J. Kidney. Dis. 2002, 39 (6) pp. 1307 - 1309 |
[28] | JUNGLEE N.A, RAHMAN S.U., WILD M., HIRST S., JIBANI M., SEALE J.R. When pure is not so pure: chloramine-related hemolytic anemia in home hemodialysis patients. Hemodial. Int. 2010, 14 (3) pp. 327 - 332 |
[29] | RICHARDSON D., BARTLET T.C., GOUTCHER E., JONES C.H., DAVISON A.M., WILL E.J. Erythropoietin resistance due to dialysate chloramine: the two-way traffic of solutes in haemodialysis. Nephrol Dial Transplant 1999, 14(11) pp. 2625 - 2627 |
[30] | AMES R.G., STRATTON J.W. Effect of chlorine dioxide water disinfection on hematologic and serum parameters of renal dialysis patients. Arch. Environ. Health. 1987, 42 (5) pp. 280 - 285 |
[31] | COMTY C., LUEHMANN D., WATHEN R., SHAPIRO F. Prescription water for chronic hemodialysis. Trans. Am. Soc. Artif. Intern. Organs. 1974, 10 pp. 189 - 196 |
[32] | CARLSON D.J., SHAPIRO F.L. Methemoglobin from well water nitrates. A complication of hemodialysis. Ann. Intern. Med. 1970, 73 (5) pp. 757 - 759 |
[33] | MANZLER A.D., SCHREINER A.W. Copper-induced acute hemolytic anemia. A new complication of hemodialysis. Ann Intern Med. 1970, 73(3) pp. 409 - 12 |
[34] | PETRIE J.J., ROW P.G. Dialysis anaemia caused by subacute zinc toxicity. Lancet. 1977, 1 (8023) pp. 1178 - 80 |
[35] | KATHURIA P., NAIR B., SCHRAM D., MEDLOCK R. Outbreak of lead poisoning in a hemodialysis unit. J. Am. Soc. Nephrol. 2004, 15 pp. 617A |
[36] | DAVENPORT A., MURCUTT G., WHITING S. Cross-sectional audit of blood lead levels in regular outpatient haemodialysis patients dialysing in north London. Nephrology (Carlton) 2009, 14 (5) pp. 476 - 481 |
[37] | HANNA-ATTISHA M., LACHANCE J., SADLER R.C., Champney Schnepp A. Elevated Blood Lead Levels in Children Associated With the FlintDrinking Water Crisis: A Spatial Analysis of Risk and Public Health Response. Am. J. Public. Health. 2016, 106 (2) pp. 283 - 90 |
[38] | KESHAVIAH P., LUEHMANN D., SHAPIRO F., COMPTY C. Investigation of the Risks and Hazards Associated with Hemodialysis Systems, (Technical Report, Contract #223-78-5046) Silver Spring, MD: U.S. Dept. of Health and Human Services, Public Health Service/Food and Drug Administration/Bureau of Medical Devices, June 1980 |
[39] | POLI D., PAVONE L., TANSINDA P., GOLDONI M., TAGLIAVINI D., DAVID S., MUTTI A., FRANCHINI I. Organic contamination in dialysis water: trichloroethylene as a model compound. Nephrol. Dial. Transplant. 2006, 21 (6) pp. 1618 - 25 |
[40] | SNYDER S.A., ADHAM S., REDDING A.M., CANNON F.S., dECAROLIS J., OPPENHEIMER J., WERT E.C., YOON Y. Role of membranes and activated carbon in the removal of endocrine disruptors and pharmaceuticals. Desalination 2007, 202 pp. 151 - 181 |
[41] | CAPPELLI G., BALLESTRI M., PERRONE S., CIUFFREDA A., INGUAGGIATO P., ALBERTAZZI A. Biofilms invade nephrology: effects in hemodialysis. Blood Purif. 2000, 18 (3) pp. 224 - 30 |
[42] | BERNICK J.J., PORT F.K., FAVERO M.S., BROWN D.G. Bacterial and endotoxin permeability of hemodialysis membranes. Kidney Int. 1979, 16 (4) pp. 491 - 496 |
[43] | BOMMER J., BECKER K.P., URBASCHEK R. Potential transfer of endotoxin across high-flux polysulfone membranes. J. Am. Soc. Nephrol. 1996, 7(6) pp. 883 - 888 |
[44] | TAO X., HOENICH N., HANDELMAN S.K., LEVIN N.W., KOTANKO P., HANDELMAN G.J. Transfer of low-molecular weight single-stranded DNA through the membrane of a high-flux dialyzer. Int J Artif Organs. 2014, 37 (7) pp. 529 - 38 |
[45] |
|
[46] | VANHOLDER R., VAN HAECKE E., VEYS N., RINGOIR S. Endotoxin transfer through dialysis membranes: small-versus large-pore membranes. Nephrol. Dial. Transplant. 1992, 7(4) pp. 333 - 339 |
[47] | WEBER V., LINSBERGER I., ROSSMANITH E., WEBER C., FALKENHAGEN D. Pyrogen transfer across high- and low-flux hemodialysis membranes. Artif Organs. 2004, 28 (2) 210 - 7 |
[48] | SCHINDLER R., BECK W., DEPPISCH R., AUSSIEKER M., WILDE A., |
[49] | SCHINDLER R., CHRIST-KOHLRAUSCH F., FREI U., SHALDON S. Differences in the permeability of high-flux dialyzer membranes for bacterial pyrogens. Clin Nephrol. 2003; 59 (6) pp. 447 - 54 |
[50] | LONNEMANN G., SERENI L., LEMKE H.D., TETTA C. Pyrogen retention by highly permeable synthetic membranes during in vitro dialysis. Artif Organs. 2001, 25 (12) pp. 951 - 60 |
[51] | EVANS R.C., HOLMES C.J. In vitro study of the transfer of cytokine-inducing substances across selected high-flux hemodialysis membranes. Blood Purif. 1991, 9 (2) pp. 92 - 101 |
[52] | LONNEMANN G. Chronic inflammation in hemodialysis: the role of contaminated dialysate. Blood Purif. 2000, 18(3) pp. 214 - 23 |
[53] | DAVENPORT A. Complications of hemodialysis treatments due to dialysate contamination and composition errors. Hemodial. Int. 2015, 19 (Suppl 3) pp. S30 - 3 |
[54] | DAWIDS S.G., VEJLSGAARD R. Bacteriological and clinical evaluation of different dialysate delivery systems. Acta Med. Scand. 1976, 199 (3) pp. 151 - 155 |
[55] | FAVERO M.S., PETERS N.J., BOYER K.M., CARSON L.A., BOND W.W. Microbial contamination of renal dialysis systems and associated risks. Trans. Am. Soc. Artif. Intern. Organs. 1974, 20 pp. 175 - 183 |
[56] | FAVERO M.S., PETERSON N.J., CARSON L.A., BOND W.W., Hindman S.H. Gram-negative water bacteria in hemodialysis systems. Health Lab. Sci. 1975; 12: 321 - 334 |
[57] | BOGIALLI S.F., DI GREGORIO L., LUCENTINI E., FERRETTI M., OTTAVIANI N., UNGARO P., ABIS M., DIGRAZIA M. Management of a toxic cyanobacterium bloom (Planktothrix Rubescens) affecting an Italian drinking water basin: A case study. Environmental Science & Technology 2013, 47 (1) pp. 574 - 584 |
[58] | SZLAG D.J., SINCLAIR B., SOUTHWELL J., WESTRICK A. Cyanobacteria and cyanotoxins occurrence and removal from five high-risk conventional treatment drinking water plants. Toxins. 2015, 7 (6) pp. 2198 - 2220 |
[59] | HILBORN E.D., SOARES R.M., SERVAITES J.C., DELGADO A.G., MAGALHAES V.F., CARMICHAEL W.W., AZEVEDO S.M. Sublethal microcystin exposure and biochemical outcomes among hemodialysis patients. PLoS ONE 2013; 8(7):e69518 |
[60] | JOCHIMSEN E.M., CARMICHAEL W.W., AN J.S., CARDO D.M., COOKSON S.T., HOLMES C.E., ANTUNES M.B., de MELO FILHO D.A., LYRA T.M., BARRETO V.S., AZEVEDO S.M., JARVIS W.R. Liver failure and death after exposure to microcystins at a hemodialysis center in Brazil. N Engl J Med 1998, 338 (13) pp. 873 - 878 |
[61] | AZEVEDO S.M., CARMICHAEL W.W., JOCHIMSEN E.M., RINEHART K.L., LAU S., SHAW G.R., EAGLESHAM G.K. Human intoxication by microcystins during renal dialysis treatment in Caruaru-Brazil. Toxicology 2002, 181 - 182 pp. 441 - 446 |
[62] | POURIA S., DE ANDRADE A., BARBOSA J., CAVALCANTI R.L., BARRETO V.T., WARD C.J. Fatal microcystin intoxication in haemodialysis unit in Caruaru. Brazil. Lancet 1998; 352 (9121) pp. 21 - 26 |
[63] | SOARES R.M., YUAN M., SERVAITES J.C., DELGADO A., MAGALHAES V.F., HILBORN E.D., CARMICHAEL W.W., AZEVEDO S.M. Sublethal exposure from microcystins to renal insufficiency patients in Rio de Janeiro. Brazil. Environ. Toxicol 2006, 21 (2) pp. 95 - 103 |
[64] | CARMICHAEL W.W., AZEVEDO S.F., AN J.S., MOLICA R.J.R., JOCHIMSENEM E.M., LAU S., RINEHART K.L., SHAW G.R., EAGLESHAM G.K. Human fatalities from cyanobacteria: chemical and biological evidence for cyanotoxins. Environ. Health. Perspect. 2001; 109 (7) pp. 663 - 668 |
[65] |
|
[66] | ARVANITIDOU M., SPAIA S., VELEGRAKI A., PAZARLOGLOU M., KANETIDIS D., PANGIDIS P., ASKEPIDIS N., KATSINAS C., VAYONAS G., KATSOUYANNOPOULOS V. High level of recovery of fungi from water and dialysate in haemodialysis units. J. Hosp. Infect. 2000, 45 (3) pp. 225 - 30 |
[67] | United States Pharmacopeia. <1231> Water for Pharmaceutical Purposes (Rockville, MD, March 8, 2017) |
[68] | ISO 23500-4:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
[69] | ISO 23500-5:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
УДК 628.1.038:616.61 - 78:006.354 | ОКС 11.040.60 |
Ключевые слова: гемодиализ, вода для диализа, микробиология, требования, испытания |