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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Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

J Diabetes Sci Technol. 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.

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Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen.

The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email. The ends of the whiskers represent the minimum and maximum values, respectively. Curr Med Res Opin. Parenteral infusion equipment, Medical instruments, 116608-1 equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns.


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STN EN ISO zrušená | SUTN

In the current study, all single ido, with each pen, were delivered within the ISO limits, despite the larger pen sample size. Open in a separate window.

A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition. All measurements were performed by a single investigator to eliminate potential isso variability. For each dose application, a new injection needle was used and an air shot included before the injection. Your basket is empty.

BS EN ISO 11608-1:2015

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. Find Similar Items This product falls into the following categories. Author information Copyright and License information Disclaimer.

Penfornis A, Horvat K. Dose accuracy and injection 11608–1 dynamics of a novel disposable insulin pen. Take the smart route to manage medical device compliance. However, the difference in dosing accuracy between SS and FT cannot be considered clinically relevant.

Declaration of Conflicting Interests: Needle-based injection systems for medical use—requirements and test methods—part 1: The line near the middle of each box represents the median 50th percentile. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin.

This ensures that you are always up-to-date and saves you both time and money. Please download Chrome or Firefox or view our browser tips. Needle-based injection systems Status: The balance was zeroed before each dose of insulin was deposited and weighed.


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. The benefits of a subscription: Requirements and test methods.

However, contrary to the new ISO 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.

Assessment of patient-reported outcomes of insulin pen devices versus conventional vial and syringe. You need to log in before adding standards to the monitoring service. International Organization for Standardization. Start Webshop Product catalog Product presentation. Results Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. 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.

Study on the dosing accuracy of commonly used disposable insulin pens.