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Technical requirements for medical cleaning fluid
Date [2020-09-02 10:09]【 】Times

medical Cleaning liquid The technical requirements are as follows:


1、 Impurity limit: refer to GB 9985 for the limit of fluorescent whitening agent, methanol, formaldehyde, arsenic (calculated as arsenic in 1% solution) and heavy metal (Pb in 1% solution).


2、 Appearance: the liquid product should be clear and transparent, without stratification, suspended solids or precipitation, no peculiar smell, and the color should be light, consistent with the description in the manual; the solid product should have a correct appearance, uniform color, no obvious impurities and stains, consistent with the description in the manual.


3、 Metal corrosivity: neutral medical cleaning solution has no corrosion to metal; acidic and alkaline medical cleaning fluid has no corrosion or only slight corrosion to metal, which will not accelerate the phenomenon of rust; the corrosion degree of medical cleaning fluid to instruments should not be stronger than that of pure water washing. The test method is shown in Appendix A.


 Cleaning liquid


4、 Content of active ingredients: the content of active ingredients in medical cleaning fluid should meet the requirements of enterprise standards.


5、 Reduce water hardness: medical cleaning fluid should be able to remove metal ions (such as Ca2 + and Mg2 +) in water, reduce the hardness of water, and prevent scale deposition from damaging the appearance and function of medical devices. Methods refer to GB / T 5750.4.


6、 Low foaming: medical cleaning fluid should be low foam type, easy to rinse clean.


7、 Stability


1. Stability of physical properties. Under the condition of high temperature and low temperature storage, the physical properties of the product shall remain unchanged


a) Heating test: the heating test is qualified if it is placed in 40 ℃± 1 ℃ incubator for 24h, and no stratification, turbidity and odor change are observed immediately.

b) Low temperature test: put it in the refrigerator at - 10 ℃± 1 ℃ for 24h, take it out and return to room temperature, and observe that there is no crystallization and precipitation, so the low temperature test is qualified.


2. Validity after unsealing. Products should be marked with the expiration date after opening. Within the period of validity after the label is opened, the decrease rate of the content of active ingredients shall be ≤ 10% or the cleaning effect shall meet the requirements.


3. Content stability of active ingredients. The validity period should be more than 1 year. Under the conditions of room temperature, dark and sealed storage, the decrease rate of the content of active ingredients should be less than or equal to 10% within the validity period of the label; if the effective ingredients cannot be determined, the cleaning effect should meet the requirements. Natural storage or accelerated test (storage at 37 ℃ for 90 days) can be used. If the decrease rate of active ingredient content is less than or equal to 10%, the validity period can be set as 1 year. Enzyme containing medicine Cleaning liquid Under the conditions of room temperature, dark and sealed storage, the decrease rate of enzyme activity should be ≤ 20% within the label validity period. See Appendix B for the test method.


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