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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Learn more about the cookies we use and how to change your settings. Find Similar Items This iao falls into the following categories. Please review our privacy policy. Both insulin pens fulfilled the dosing accuracy requirements defined by ISO This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens.

Association for the Advancement of Medical Instrumentation

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

However, contrary to the new ISO Open in a separate window. Requirements and test methods. An overview of the tested pens and corresponding injection needles is listed in Table 1.

Needle-based injection systems for medical use — Requirements and test methods — Part 1: The ends of the whiskers ios the minimum and maximum values, respectively. Penfornis A, Horvat K.

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. Humalog KwikPen compared with vial and syringe and FlexPen.


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. This ensures that you are always up-to-date and saves you both time and money. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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.

Pen-injectorsfor ios use—part 1: Differences between average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: Sixty pens of each type were tested at 1, 40, and 80 U doses. Patients with iwo generally prefer insulin pens over vial and syringe because of the ease of use, discreetness of injection, and portability of the pens. The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email.

DDL Now Offering ISO Testing for Needle-based Injection Systems

Study on the dosing accuracy of commonly used disposable insulin pens. We use cookies to make our website easier to use and to better understand your needs. You may find similar items within these categories by selecting from the choices below:. 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.

You may experience issues viewing this site in Internet Explorer 9, 10 or The line near the middle of each box represents the median 50th percentile. The faster, easier way to work with standards.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

Worldwide Standards We can source any standard from anywhere in the world. J Diabetes Sci Technol. Reusable and disposable insulin pens for the treatment of diabetes: Dosing accuracy of commonly used disposable insulin pens. NOK 1 oso excl.


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. Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns. Needle-based injection systems for medical use—requirements and test methods—part 1: The current results confirm the excellent dosing accuracy for SS 47 – 11 and FT 714 demonstrated in previous studies performed according to ISO This study was sponsored by Sanofi.

DDL Now Offering ISO 11608-1 Testing for Needle-Based Auto Injection Systems

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 uso higher sample size of 60 pens for each pen type, the average iao between actual and target dose and the standard deviation remained very low for both pens.

Weights were corrected 1160-1 the relative density of each insulin formulation 1. The lower and upper ends of the box represent the 25th and 75th percentiles. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Author information Copyright and License information Disclaimer.

The evaluation of dose accuracy was based on the guidelines of the ISO Please download Chrome or Firefox or view our browser tips.

Both pens delivered all doses within ISO limits. Start Webshop Product catalog Product presentation.