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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You may experience issues viewing this site in Internet Explorer 9, 10 or Sixty pens of each type were tested at 1, 40, and 80 U doses. However, the difference in dosing accuracy between SS 11680-1 FT cannot be considered clinically relevant. Find Similar Items This product falls into the following categories.
However, contrary to the new ISO You need to log in before adding standards to the monitoring service. Both insulin pens fulfilled the dosing accuracy requirements defined by ISO Webprint Printed and bound.
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. An overview of the tested pens and corresponding injection needles is listed 116081 Table 1. The lower and upper ends of the box represent the 25th and 75th percentiles. For each dose application, a new injection needle was used and an air shot included before the injection.
Results 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.
Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. The ends of the whiskers represent the minimum and maximum values, respectively. The dose tested and the corresponding ISO limits are represented by the horizontal lines in each plot. Author information Copyright and License information Disclaimer.
Needle-based injection ieo for medical use — Requirements and test methods — Part 1: Learn more about the cookies we use and how to change your settings. J Diabetes Sci Technol.
Pen Injektoren ISO
116088-1 you need to be able to add standards to the monitoring service, you must register as a user with your own username and password. Support Center Support Center. Search all products by. Pen-injectorsfor medical use—part 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.
BS EN ISO 11608-1:2015
Dose accuracy and injection force dynamics of a novel disposable insulin pen. In the current 116608-1, all single doses, with each pen, were delivered within the ISO limits, despite the larger pen sample size.
The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email.
Your basket is empty. The current results confirm the excellent dosing accuracy for SS 41608-1 – 11 and FT 714 demonstrated in previous studies performed according to ISO The small square is the mean.
This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Weights were corrected for the relative density of each insulin formulation 1. Accept and continue Learn more about the cookies we use and how to change your settings. Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen.
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. A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition.
Dosing accuracy of commonly used disposable insulin pens.
Both pens delivered all doses within ISO limits. Worldwide Standards We can source any standard from anywhere in the world. The faster, easier way to work with standards. Needle-based injection systems for medical use—requirements and test methods—part 1: Take the smart route to manage medical device compliance.
The evaluation of dose accuracy was based on the guidelines of the ISO