Method for determining the mortality of sterilization process in sterilization process - overkill method
B.1 General
B.1.1 The basis for the definition of this process is the inactivation of the reference microorganisms, which has been widely used. The method of the present sterilization process usually identified conserved, with the processing level may exceed the level of treatment required to achieve the desired sterility.
A guide to this method can be found in ISO 14161.
B.1.2 The definition of a conservative process requires the use of one of the following methods a) or b):
a) Semi-period method: A total of three consecutive tests should be performed with the result that all biological indicators (number of colonies not less than 106) are inactivated to confirm the minimum action time. The role of time should be provided for this purpose at least twice the minimum time. A short period of time with viable microorganisms should be run at the same time to demonstrate the suitability of survival techniques.
b) Periodic calculation: Using one of the methods described in A.3, determine the conventional processing parameters for the biomarker spore log reduction value of at least 12 SLR. The number of cycles is determined according to the method used.
B.1.3 The conditions for the reactivation of biological indicators in the validation, including the incubation time, should be determined and documented. The culture time should take into account the possibility of delayed growth of spores exposed to EO.
B.2 procedure
B.2.1 Determining the worst product or PCD, which is at least as difficult to sterilize as the most difficult item used in the sterilization process.
B.2.2 Determine where the most difficult to achieve sterilization conditions in the product.
B.2.3 Establish sterilization process monitoring by one of the following methods, including known microbial counts and known resistance to EO:
a) placing the biological indicator in the location of the product where it is most difficult to achieve sterilization, or placing it in a PCD, or
b) Inoculate appropriate reference microorganisms in the product where it is most difficult to achieve sterilization conditions.
See ISO 14937:2000, Table A.1.
If the monitoring location is not the most difficult to sterilize, determine its relationship to the most difficult location.
B.2.4 The above PCD is packaged using a packaging method equivalent to that of a conventional product and placed in the sterilized article.
B.2.5 Exposing the sterilized article to EO using less lethal conditions than the specified sterilization process.
B.2.6 If the inactivation of the known microbial population has been confirmed in accordance with A.3, the expected probability of survival of the known microorganism is inferred and the required SAL is taken into account to determine the extent of the sterilization process.
Common medical masks are used to block spouts exhaled from the oral cavity and nasal cavity, and can be used for one-time hygiene care in ordinary medical environments with the lowest protection level. It is suitable for general hygiene care activities, such as sanitary cleaning, liquid distribution, cleaning bed units, etc., or the blocking or protection of particles other than pathogenic microorganisms such as pollen.
Conforms to the relevant registered product standard (YZB), generally lacks the filtration efficiency requirements for particles and bacteria, or the filtration efficiency requirements for particles and bacteria are lower than medical surgical masks and medical protective masks, only reaching 20.0% for 0.3μm diameter aerosols -25.0% protection effect, can not reach the filtration efficiency of particles and bacteria, can not effectively prevent pathogens from invading through the respiratory tract, can not be used for clinical invasive operations, nor can it protect particles and bacteria and viruses, only limited to dust particles Or aerosol plays a certain mechanical barrier.
1. Carefully cover the mouth and nose with a mask and fasten it to minimize the gap between the face and the mask;
2. Avoid touching the mask when using it-after touching the used mask, for example to remove or clean the mask, wash your hands with soap and water or use alcohol hand sanitizer;
3. After the mask is wet or contaminated with moisture, replace with a new clean and dry mask;
4. Do not reuse disposable masks. Disposable masks should be discarded after each use.
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