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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Association for the Advancement of Medical Instrumentation

Penfornis A, Horvat K. Weights were corrected for the relative density of each insulin formulation 1. 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.

Both insulin pens fulfilled the dosing accuracy requirements defined by ISO You may experience issues viewing this site in Internet Explorer 9, 10 or All measurements were performed by a single investigator to eliminate potential investigator variability. Both pens delivered all doses within ISO limits.

This study was sponsored by Sanofi. You may find similar items within these categories by selecting from the choices below:. We use cookies isso make our website easier to use and to better understand your needs.


This service is not available if you are a URL user where you do not log in with an email address. Pen devices to improve patient adherence with insulin therapy in type 2 diabetes. 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.

This ensures that you are always up-to-date and saves you both time and money. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Author information Copyright and License information Disclaimer.

Pen Injektoren ISO

For each dose application, a new injection needle was used and an air shot included before the injection. Expert Opin Drug Deliv.

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sio Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling BS EN ISO Curr Med Res Opin. Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. 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.

The 11608-1 tested and the corresponding ISO limits are represented by the horizontal lines in each plot. Take the smart route to manage medical device compliance.


This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

The faster, easier way to work with standards. 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. The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email. Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen. 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.

The benefits of a subscription: Pen-injectorsfor medical use—part 1: A web subscription provides an easy and secure access to standards, and you are iwo to always have the latest edition. Each dose was deposited in a beaker containing a 0. Webprint Printed and bound. Accept and continue Learn more about the cookies we use and how to change your settings. Reusable and disposable insulin pens for the treatment of diabetes: