ГОСТ Р ИСО 17665-1—2016
(34] EN 13060Малые паровые стерилизаторы (Small steam sterilizers)
(35] GAMP 4 The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in
Pharmaceutical Manufacture, December 2001. ISPE (International Society for Pharmaceutical Engineering), 3109 W.
Dr. Martin Luther King. Jr. Bivd.. Suite 250. Tampa. FL 33607
(36] Global Harmonization Task Force (GHTF). Study Group 1 (SG1). Document N029R15. dated 3 December. 2004
(37] Halvorson. H. O. and Ziegler, N.R. Applications of statistics to problems in bacteriology. Journal of Bacteriology.
25(2): pp. 101—118. 1932
(38] IEC 61010-2-040. Safety requirements for electrical equipment for measurement, control, and laboratory use —
Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
(39] Irvine. Th. F. and Liley. P.E. Steam and Gas tables with computer equations. Academic Press. 1984
(40] Momssey, R.F. and Phillips, G.B.. eds. Sterilization technology: A practical guide for manufacturers and users of
health care products. New York. Van Nostrand Reinhold. 1995
(41] National Canners Association. Manual for food Canners and Processors. Vol. 1. AVI Publishing Co.. Westport. CT.
1968
(42] PDA. Validation of steam sterilization cycles. Technical monograph No. 1. Parenteral Drug Association. 1978
(43] Pflug. I.J. Microbiology and Engineering of Sterilization Processes. 1999 Tenth Edition. Environmental Sterilization
Laboratory. 1920 South First SL Minneapolis. Philadelphia. PA, 1978
(44] Pflug. I.J. and Holkomb. R.G. Principles of thermal destruction of microorganisms. Disinfection. Sterilization and
Preservation. Block. S.S.. ed.. Lea and Febinger. Philadelphia. PA. 1983
(45] Pflug. I.J. and Kristen. D.E. Carrying out Biological Qualification, the Control Operation of Moist-Heat (Steam
Sterilization) Processes for Producing Sterile Pharmaceuticals and Medical Devices. PDA. Journal of Pharmaceutical
Science and Technology. 54 (2) 2000
(46] Sattar. S.A. and Springthorre. V.S. Methods under development for evaluating the antimicrobial activity ofgermicides.
Proceedings of the International Symposium on Chemical Germicides in Health Care. Cincinnati. Ohio. May 1994.
Polyscience Publications Inc. pp 237—254. 1995
(47] ИСО 18472
Стерилизация продуктов здравоохранения. Биологические и химические индикаторы.
Испытательное оборудование (Sterilization of health care products. Biological and chem
ical indicators. Test equipment)
(48] ИСО 22442-1
Медицинские изделия, использующие животные ткани и их производные. Часть 1.
Применение менеджмента риска (Medical devices utilizing animal tissues and their deriv
atives. Part 1: Application of risk management)
(49] ИСО 22442-2
Медицинские изделия, использующие животные ткани и их производные. Часть 2.
Контроль источника, сбора и обработки (Medical devices utilizing animal tissues and
their derivatives. Part 2: Controls on sourcing, collection and handling)
(50] ИСО 22442-3
Медицинские изделия, использующие медицинские изделия и их производные. Часть 3.
Валидация уничтожения и/или инактивации вирусов и инфекционных агентов спон-
гиозной формы энцефалопатии (spongiform encephalopathy. TSE) (Medical devices uti
lizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inacti
vation of viruses and transmissible spongiform encephalopathy (TSE) agents)
(51] Международный словарь основных и общих терминов метрологии (VIM), BIPM, IEC. IFCC. ИСО, IUPAC.
IUPAP. OIML. 2nd ed. Geneva. 1993 (International Vocabulary of Basic and General Terms in Metrology (VIM).
BIPM. IEC. IFCC. ISO. IUPAC. IUPAP. OIML. 2nd ed. Geneva. 1993)
35