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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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Take the smart route to manage medical device compliance. J Diabetes Sci Technol. Humalog KwikPen compared with vial and syringe and FlexPen.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This could not be confirmed according isk the new standard in the current study where equivalent results were obtained with the 2 pens.

NBN EN ISO 11608-1

Learn more about the cookies we use and how to change your settings. This article has been cited by other articles in PMC. Needle-based injection systems Status: Author information Copyright and License information Disclaimer. However, the iwo in dosing accuracy between SS and FT cannot be considered clinically relevant. The small square is the mean.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

Both pens delivered all doses within ISO limits. Curr Med Res Opin. Declaration of Conflicting Interests: However, contrary to the new ISO Requirements and test methods. Your basket is empty. A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition.


Results Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. 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. The benefits of a subscription: Please review our privacy policy.

Association for the Advancement of Medical Instrumentation

The ends of the whiskers represent the minimum and maximum values, respectively. Differences 11608- average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: Read more about subscriptions.

For each dose application, a new injection needle was used and an air shot included before the injection. The current results confirm the excellent dosing accuracy for SS 47 – 11 and FT 714 demonstrated in previous studies performed according to ISO Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen.

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Penfornis A, Horvat K. Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen.

Each dose was deposited in a beaker containing a 0. Weights were corrected for the relative density of each insulin formulation 1. Both insulin pens fulfilled the dosing accuracy requirements defined by ISO An overview of the tested pens and corresponding injection needles is listed in Table 1.


The line near the middle of each box represents the median 50th percentile. 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.

Reusable and disposable insulin pens for the treatment of diabetes: This study was sponsored by Sanofi. Study on the dosing 116608-1 of commonly used disposable insulin pens.

Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns. The lower and upper ends of the box represent the 25th and 75th percentiles.

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Worldwide Standards We can source any standard from anywhere in the world. 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.

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 expelled.