In the verification of sterilization procedure, although the sterilization effect can be evaluated by monitoring some parameters in the sterilization process, the sterilization degree of biological indicators is the most intuitive index to evaluate the effectiveness of a sterilization procedure. Commercial standard biological indicators can be used, and spores prepared by the most tolerant microorganisms isolated in the daily monitoring of contaminated bacteria can also be used. In the verification test of biological indicators, it is necessary to determine the D value of spores under actual sterilization conditions and determine the purity and quantity of spores. During verification, the microbial dosage of the biological indicator should be greater than the microbial contamination in daily detection, and it has strong tolerance to ensure greater safety in the sterilization process. In the final sterilization method, biological indicators should be placed in different parts of the sterilization cabinet. And prevent the indicator from directly contacting the sterilized articles. After sterilization according to the set conditions, the biological indicator was taken out and cultured in the culture medium respectively to determine whether the spores in the biological indicator were completely killed.
Generally, the sterilization verification of overkill products does not consider the level of microbial contamination, and commercial biological indicators can be used. For products with poor tolerance to sterilization methods, when designing sterilization procedures, we should predict the microbial pollution level in the production process according to experience, and select the number of strains and spores of biological indicators. The sterility assurance of such products should be evaluated by monitoring the quantity and tolerance of microbial contamination and the data obtained from the verification of sterilization procedures before sterilization of each batch of products.
In the sterilization biological monitoring of medical institutions, the national standard WS3 10 has clearly stipulated that:
1, the pressure steam sterilization process is once a week, and the biological indicator is sterilized by pressure steam;
2. Sterilize each batch of monitored ethylene oxide gas and use ethylene oxide sterilization biological indicator;
3, low temperature plasma sterilization monitoring once a day, using low temperature plasma sterilization biological indicators.
The above three sterilization methods are also the main sterilization methods in 20 12 medical institutions, among which pressure steam sterilization is the most widely used.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; By examining human samples, information can be provided for medical or diagnostic purposes.
Judging from the data in the above two paragraphs, the biological indicator of steam sterilizer does not belong to medical devices.