ISO 11608-1 PDF

February 17, 2019

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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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. Each dose was deposited in a beaker 11608-11 a 0.

ISO 11608-1:2014

Published online Jul An 16108-1 of the tested pens and corresponding injection needles is listed in Table 1. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen.

The plunger was kept depressed after each dose for 10 seconds and 6 seconds for SS and FT, respectively, to ensure that sio entire dialed dose had been expelled. Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO

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Take the smart route to manage medical device compliance. Needle-based injection systems for medical use. Results Both insulin pens showed excellent dosing accuracy at all dosage levels 11068-1 2. Clarke A, Spollett G. A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition.

The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email. Humalog KwikPen compared with vial and syringe and FlexPen. The ends of the whiskers represent the minimum and maximum values, respectively.


Pen devices to improve patient adherence with insulin therapy in type 2 diabetes. Both pens delivered all doses within ISO limits. Study on the dosing accuracy of commonly used disposable insulin pens. However, the difference in dosing accuracy between SS and FT cannot be considered clinically relevant.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Needle-based injection systems for medical use—requirements and test methods—part 1: J Diabetes Sci Technol.

Assessment of patient-reported outcomes of insulin pen devices versus conventional vial and syringe. 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. Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns.

Click to learn more. Read more about subscriptions. Webprint Printed and bound. Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. Furthermore, each target dose was delivered from the front one-third, middle one-third, and rear one-third of the pen cartridge with a corresponding transfer step in between the doses Figure 1. Requirements and test methods. Pen-injectorsfor medical use—part 1: Expert Opin Drug Deliv.

This article has been cited by other articles in PMC. The evaluation of dose accuracy was based on the guidelines of the ISO 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. Worldwide Standards We can source any standard from anywhere in the world.


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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. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin. NOK 1 ,00 excl. The dose tested and the corresponding ISO limits are represented by the horizontal lines in each plot.

The lower and upper ends of the box represent the 25th and 75th percentiles. Start Webshop Product catalog Product presentation. Monitoring 116088-1 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 1608-1.

Learn more about the cookies we use and how to change your settings. The current results confirm the excellent dosing accuracy for SS 4ixo – 11 and FT 714 demonstrated in previous studies performed according to ISO 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.

Sixty pens 11608- each type were tested at 1, 40, and 80 U doses. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling BS EN ISO Weights were corrected for the relative density of each insulin formulation 1. We use cookies to make our website easier to use and to better understand your needs. In the current study, all single doses, with each pen, were delivered within the ISO limits, despite the larger pen sample size.