1.Study on Testing Methods of Pen-injector's Dosing Accuracy.
Chinese Journal of Medical Instrumentation 2020;44(6):549-552
OBJECTIVE:
An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests.
METHODS:
According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed.
RESULTS:
After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested.
CONCLUSIONS
Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.
Disposable Equipment/standards*
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Equipment Safety
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Injections, Intradermal/instrumentation*
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Syringes
2.Present application situation of medical consumble materials and the standard management.
Yin-bao CHONG ; Ma-li ZHAO ; Nan LI
Chinese Journal of Medical Instrumentation 2005;29(6):460-461
This paper introduces the present application situation of medical consumable materials in consumption, use, quality control and computer management. It presents the concrete contents of standard management in quality guarantee, rules and regulations, and cost reduction.
Costs and Cost Analysis
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Disposable Equipment
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economics
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standards
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Quality Control
3.Determination of residual cyclohexanone in disposable infusion set by gas chromatography.
Li ZHANG ; Yan WEN ; Tao HE ; Minzhu WANG ; Pinghua XU
Chinese Journal of Medical Instrumentation 2014;38(5):381-385
An effective GC method was established for contents determination of the residual solvent of cyclohexanone in infusion sets for single use. The cyclohexanone in infusion sets for single use products were extracted with circular pump, using ethylalcohol as the extraction solven, then the extract followed by analysis of gas chromatography-tandem mass spectrometry. The method was simple, rapid, sensitive and accurate, Cyclohexanone showed good linearity in the range of (5.5-190.9) μg/mL, the correlation coefficient was 0.999 0, the detection limit (S/N = 3) was 0.133 μg/mL and limits of quantitation (S/N = 10) was 1.33 μg/mL. The spiked average recoveries ranged from 98% to 99%. The relative standard deviations (RSDs) of the method ranged from 1.03% to 1.98%. The method was simple, fast, sensitive and accurate, and may serve as a mass control method for residual cyclohexanone in disposable infusion sets for single use.
Cyclohexanones
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analysis
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Disposable Equipment
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standards
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Gas Chromatography-Mass Spectrometry
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Solvents
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analysis