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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NOK 1 ,00 excl. Search all products by. International Organization for Standardization. Open in a separate window. An is of the tested pens and corresponding injection needles is listed in Table 1.

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Assessment of patient-reported outcomes of insulin pen devices versus conventional vial and syringe. National Center for Biotechnology InformationU. However, the difference in dosing accuracy between SS and FT cannot be 11608–1 clinically relevant. Sixty pens of each type were tested at 1, 40, and 80 U doses.

Both insulin pens fulfilled the dosing accuracy requirements defined by ISO Author information Copyright and License information Disclaimer. The line near the middle of each box represents the median 50th percentile.

Humalog KwikPen compared with vial and syringe and FlexPen. Requirements and test methods. This ensures that you are always up-to-date and saves you both time and money. However, contrary to the new ISO Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling BS EN ISO The lower and upper isp of the box represent the 25th and 75th percentiles.


ISO 11608-1:2014

Dosing accuracy of commonly used disposable insulin pens. Each dose was deposited in a beaker containing a 0. Standards monitoring is a free service designed for you who wish to be alerted of changes to or new editions of the standards required in your work. Find Similar Items This product falls into the following categories. All measurements were performed by a single investigator to eliminate potential investigator variability.

Pen Injektoren ISO

Clarke A, Spollett G. Click to learn more. Differences between average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: This article has been cited by other articles in PMC.

The arithmetic average of the actual 111608-1 was calculated, as well as the standard deviation, the average deviation percentage from the target dose, and the statistical tolerance interval. For each dose application, a new injection needle was used and an air shot included before the injection. Expert Opin Drug Deliv.

11680-1 Support Center Support Center. 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. Both pens delivered all doses within ISO limits. Curr Med Res Opin. The balance was zeroed before each dose of insulin was deposited and weighed. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin.


Published online Jul Needle-based injection systems for medical use. Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns. The plunger was kept depressed after each dose for 10 seconds and 6 seconds for SS and FT, respectively, to ensure that the entire dialed dose had been 1608-1.

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To assure the accuracy of the injected dose, insulin pens need to fulfill ISO requirements for dosing accuracy, which they have demonstrated in several studies. Study on the dosing accuracy of commonly used disposable insulin pens. Target doses of 1 U minimum40 U middleiiso 80 U maximum were ejected and measured for each pen. Reusable and disposable insulin pens for the treatment of diabetes: Applying the new dosing scheme with single measurements of each target dose delivered iiso 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 111608-1.

Monitoring Standards monitoring is a free service designed for you who wish to be alerted of changes to or new editions of the standards required in your work. This study was sponsored by Sanofi. You may find similar items within these categories by selecting from the choices below:.

The small square is the mean. This website is isoo viewed 1108-1 browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

You may experience issues viewing this site in Internet Explorer 9, 10 or The evaluation of dose accuracy was based on the guidelines of the ISO

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