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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Please download Chrome or Firefox or view our browser tips. Dose jso and injection force dynamics of a novel disposable insulin pen.

All measurements were performed by a single investigator to eliminate potential investigator variability. Click to learn more. Reusable and disposable insulin pens for the treatment of diabetes: Each dose was deposited in a beaker containing a 0. Pen-injectorsfor medical use—part 1: The evaluation of dose accuracy was based on the guidelines of the ISO Take the smart route to manage medical device compliance.

ieo Results Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns.

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DDL Now Offering ISO Testing for Needle-based Injection Systems

Worldwide Standards We can source any standard from anywhere in the world. Read more about subscriptions. Differences between average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.


However, contrary to the new ISO The dose tested and the corresponding ISO limits are represented by the horizontal lines in each plot. Curr Med Res Opin.

Association for the Advancement of Medical Instrumentation

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The balance was zeroed before each dose of insulin was deposited and weighed. Open in a separate window. Requirements and test methods Automated functions.

The plunger was kept depressed after each dose for 10 seconds and ido seconds for SS and FT, respectively, to ensure that the entire dialed dose had been expelled. Ido Opin Drug Deliv. For each dose application, a new injection needle was used and an air shot included before the injection. Dosing accuracy of commonly used disposable insulin pens. Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

Patients with diabetes generally prefer insulin pens over vial and syringe because of the ease of use, discreetness of injection, and portability of the pens. You need to log in before adding standards to the monitoring service.

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Support Center Support Center. The lower and upper ends of the box represent the 25th and 75th percentiles. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen.

NOK 1 ,00 excl. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin. This article has been cited by other articles in PMC. The line near the middle of each box represents the median 50th percentile.

This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood oso BS EN ISO Requirements and test methods.

Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2.

Sixty pens of each type were tested at 1, 40, and 80 U doses. J Diabetes Sci Technol. Both pens delivered all doses within ISO limits. The ends of the whiskers represent the minimum and maximum values, respectively. However, the difference in dosing accuracy between SS and FT cannot be considered clinically relevant.