Study on Testing Methods of Pen-injector's Dosing Accuracy.
10.3969/j.issn.1671-7104.2020.06.017
- Author:
Binbin ZHANG
1
Author Information
1. Shanghai Testing and Inspection Institute for Medical Devices, Shanghai, 201318.
- Publication Type:Journal Article
- Keywords:
dose accuracy;
pen-injector;
tolerance intervals
- MeSH:
Disposable Equipment/standards*;
Equipment Safety;
Injections, Intradermal/instrumentation*;
Syringes
- From:
Chinese Journal of Medical Instrumentation
2020;44(6):549-552
- CountryChina
- Language:Chinese
-
Abstract:
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.
