Ethylene Oxide Gas Sterilization of Medical Devices

被引:111
作者
Shintani, Hideharu [1 ]
机构
[1] Chuo Univ, Dept Sci & Engn, 1-13-27,Kasuga,Bunkyo, Tokyo 1120003, Japan
关键词
Medical devices; Ethylene oxide gas sterilization; Process design; Process validation; SOLID-PHASE EXTRACTION; TOXIC COMPOUNDS; CROSS-LINKING; GAMMA-RAYS; POLYURETHANE; PRODUCTS; 4,4'-METHYLENEDIANILINE; CHLOROHYDRIN; DEGRADATION; EFFICIENCY;
D O I
10.4265/bio.22.1
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.
引用
收藏
页码:1 / 16
页数:16
相关论文
共 66 条
[1]  
Aeschlimann H., 1984, NEW CEN ISO STANDARD
[2]  
Alfa M J., 1998, Disinfection, sterilization, and antisepsis in healthcare, P67
[3]   Comparison of ion plasma, vaporized hydrogen peroxide, and 100% ethylene oxide sterilizers to the 12/88 ethylene oxide gas sterilizer [J].
Alfa, MJ ;
DeGagne, P ;
Olson, N ;
Puchalski, T .
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY, 1996, 17 (02) :92-100
[4]  
Alfa MJ, 1997, INFECT CONT HOSP EP, V18, P641
[5]   Comparison of liquid chemical sterilization with peracetic acid and ethylene oxide sterilization for long narrow lumens [J].
Alfa, MJ ;
DeGagne, P ;
Olson, N ;
Hizon, R .
AMERICAN JOURNAL OF INFECTION CONTROL, 1998, 26 (05) :469-477
[6]  
American Association of Medical Instrumentation (AAMI), 2008, 17 AAMI TIR
[7]  
[Anonymous], 111382 ISO
[8]  
[Anonymous], 109937 ISO
[9]  
[Anonymous], 1998, 19 AAMI TIR
[10]  
[Anonymous], 1998, 109937 ANSIAAMIISO