A Study on Sterilization of Medical Products by Gamma-irradiation.

Gamma선 조사에 의한 의류제품의 멸균연구

Biological safety, physico-chemical and microbiological experiments were carried out in order to study the possibility of radiation sterilization on medical products, such as polyethylene and polystyrene bottles, gauze sponges and surgical silk suture. Results are as follows: 1. Biological test on plastic samples as to acute systemic toxicity, eye irritation, skin irritation, pyrogen, haemolysis showed satisfactory results. But physico-chemically, the oxidizable matter, nonvolatile residues, residue on ignition seemed to be increased slightly in irradiated samples, though the experimental results were within the range of U.S.P. 19, N.F. and K.P. III. 2. After irradiation, both plastic and gauze sponges showed considerable decrease in pH. 3. Most medical products were sterilized by 1.5 Mard. For the sterilization of the suigical silk suture, 4.5 Mrad is required dul to its radiation resistant micro-organisms. 4. Biologically, total dose of 2.5 Mrad was safe enough to sterilize the medical products, and physico-chemically the results are acceptable according to U.S.P. 19 and K.P. III. However, better results may be expected when the quality of material and additives are improved.