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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Accept and continue Learn more about the cookies we use and how to change your settings. The arithmetic average of the actual doses was calculated, as well as the standard deviation, the average deviation percentage from the target dose, and the statistical tolerance interval. Curr Med Res Ixo. 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.

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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.

Needle-based injection systems Status: Both insulin pens fulfilled the dosing accuracy requirements defined by ISO Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling BS EN ISO An overview of the tested pens and corresponding injection needles is listed in Table 1.

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

Each dose was deposited in a beaker containing a 0. NOK 1 ,00 excl. The evaluation of dose accuracy was based on the guidelines of the ISO This article has been cited by other articles in PMC.


The dose tested and the corresponding ISO limits are represented by the horizontal lines in each plot. However, contrary to the new ISO Your basket is empty.

DDL Now Offering ISO Testing for Needle-based Injection Systems

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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. Subscription – always available and updated A web subscription provides an easy and secure sio to standards, and you are guaranteed to always have the latest edition. Weights were corrected for the relative density of each 1108-1 formulation 1.

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Take the smart route to manage medical device compliance. Penfornis A, Horvat K. Needle-based injection systems for medical use—requirements and test methods—part 1: 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. Find Similar Items This product falls into the following categories.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

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 iao pen type, the average deviation between actual and target dose and the standard deviation remained very low for both pens.

For each dose application, a new injection needle was used and an air shot included before the injection. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin. We use cookies to make our website easier to use 116081 to better understand your izo. Differences between average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: Needle-based injection systems for medical use — Requirements and test methods — Part 1: Please download Chrome or Firefox or view our browser tips.


Requirements and test methods. Webprint Printed and bound. Support Center Support Center. 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. If you need to be able to add standards to the monitoring service, you must register as a user with your own 1608-1 and password.

The ends of the whiskers represent the minimum and maximum values, respectively. In the current study, all single doses, with each pen, were delivered within the ISO limits, despite the larger pen sample size.

Needle-based injection systems for medical use. The current results confirm the excellent dosing accuracy for SS 47 – 11 and Isl 714 demonstrated in previous studies performed according to ISO The lower and upper ends of the box represent the 25th and 75th percentiles.

Dosing accuracy of commonly used disposable insulin pens. All measurements were performed by a single investigator to eliminate potential investigator variability.