ISO 11608-1 PDF
STANDARD. ISO. First edition. Pen-injectors for medical use —. Part 1: Pen-injectors — Requirements and test methods. Stylos-injecteurs . Smithers Pira tests needle-based injection systems (NISs) to ISO , assessing their functional performance against the various tests specified in this. ISO Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems.
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Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. Start Webshop Product catalog Product presentation. The plunger was kept depressed after each dose for 10 seconds and 6 seconds for SS and FT, respectively, 16108-1 ensure that the entire dialed dose had been expelled.
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Study on the dosing accuracy of commonly used disposable insulin pens. Subscription – always available and updated A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition.
DDL Now Offering ISO 11608-1 Testing for Needle-Based Auto Injection Systems
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Association for the Advancement of Medical Instrumentation
The evaluation of dose accuracy was based on the guidelines of the ISO If you need to be able to add standards to the monitoring service, you must register as a user with your own username and password. Needle-based injection systems for medical use. Applying the new dosing scheme with single measurements of each target dose delivered from the front, middle, and the rear one-third of the pen and the higher sample size of 60 pens for each pen type, the average deviation between actual and target dose and the standard deviation remained very low for both pens.
However, contrary to the new ISO The dose tested and the corresponding ISO limits are represented by the horizontal lines in each plot. The arithmetic average of the actual doses was calculated, as well as the standard deviation, the average deviation percentage from the target dose, and the statistical tolerance interval. Both pens delivered all doses within ISO limits.
No single dose of SS or FT was detected outside the specified limits, and the statistical tolerance intervals defined by the ISO standards were met by both pens at all 3 dosage levels Table 2.
Reusable and disposable insulin pens for the treatment of diabetes: International Organization for Standardization. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. This service is not available if you are a URL user where you do not log in with an email kso.
Dosing accuracy of commonly used disposable insulin pens. Dose accuracy and injection force dynamics of a novel disposable insulin pen. National Center for Biotechnology InformationU. Needle-based 1608-1 systems for medical use—requirements and test methods—part 1: Assessment of patient-reported outcomes of insulin pen devices versus conventional vial and syringe.
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This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens. Weights were corrected for the relative density of each insulin formulation 1. This article has been cited by other 116081 in PMC. Author information Copyright and License information Disclaimer.
The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email. Declaration of Conflicting Interests: All measurements were performed by a single investigator 1608-1 eliminate potential investigator variability.
Pen-injectorsfor medical use—part 1: NOK 1 ,00 excl. The benefits of a subscription: Differences between average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: The average values of the actual measured doses were closer to the target dose for SS at all 3 dosage levels compared with FT Table 2.
Injection force and dose accuracy of FlexTouch for the isk of a new basal insulin. J Diabetes Sci Technol. Furthermore, each target dose was delivered from the front one-third, middle one-third, and rear one-third of the pen cartridge with a corresponding transfer step in between the doses Figure 1.
For each dose application, a new injection needle was used and an air isi included before the injection. The ends of the whiskers represent the minimum and maximum values, respectively.