TECHNICAL AND REGULATORY REQUIREMENTS FOR RADIATION STERILIZATION FACILITIES USING ELECTRON-BEAM ACCELERATORS

被引：0
|
作者：
SAYLOR, MC
PARKS, LA
HERRING, CH
机构：
[1] IRT CORP,SAN DIEGO,CA 92121
[2] ETHICON ENDO SURG,CINCINNATI,OH 45242
来源：
NUCLEAR INSTRUMENTS & METHODS IN PHYSICS RESEARCH SECTION B-BEAM INTERACTIONS WITH MATERIALS AND ATOMS | 1993年 / 79卷 / 1-4期
关键词：
D O I：
10.1016/0168-583X(93)95489-R
中图分类号：
TH7 [仪器、仪表];
学科分类号：
0804 ; 080401 ; 081102 ;
摘要：
Various technical and regulatory considerations must be addressed in order to sterilize disposable medical devices by ionizing radiation. Current practices specific to electron beam-based sterilization events are discussed and include material compatibility testing, dose setting, dose mapping, process validation and process control associated with the accelerator/conveyor system. Projected trends in regulatory guideline development are made relative to the appearance and implementation of reliable high power machine-generated sources of electrons operating in the energy range of 0.3-12 MeV.
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页码：875 / 878
页数：4
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