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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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Both pens delivered all doses within ISO limits. In 1160-81 current study, all single doses, with each pen, were delivered within the ISO limits, despite the larger pen sample size. Take the smart route to manage medical device compliance. The small square is the mean. Learn more about the cookies we use and how to change your settings.

Dose accuracy and injection force dynamics of a novel disposable insulin pen. You need to log in before adding standards to the monitoring service.

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

Click to learn more. The benefits of a subscription: Published online Jul isso Results Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Requirements and test methods Automated functions. Find Similar Items This product falls into the following categories.

However, the difference in dosing accuracy between SS and FT cannot be considered clinically relevant. The evaluation of dose accuracy was based on the guidelines of the ISO Declaration of Conflicting Interests: Start Webshop Product catalog Product presentation.

An overview of the tested pens and corresponding injection needles is listed in Table 1. Subscription – always available and updated A web subscription provides an easy and secure access to standards, and you are guaranteed to always have 11608-1 latest edition.

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Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling BS EN ISO Please download Chrome or Firefox or view our browser tips.

Needle-based injection systems for medical use — Requirements and test methods — Part 1: A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition.

Both insulin pens fulfilled the dosing accuracy requirements defined by ISO J Diabetes Sci Technol. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The moment new editions ido the standards you monitor are released, changes are made, or appendixes are published, you will be iwo by email. Target doses of 1 U minimum40 U middleand 80 U oso were ejected and measured for each pen.

However, contrary to the new ISO You may experience issues viewing this site in Internet Explorer 9, 10 or 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 isk type, the average deviation between actual and target dose and the standard deviation remained very low for both pens.

The lower and upper ends of the box represent the 25th and 75th percentiles.

ISO 11608-1:2014

Worldwide Standards We can source any standard from anywhere in the world. 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. Patients 1160-1 diabetes generally prefer insulin pens over vial and syringe because of the ease of use, discreetness of injection, and portability of the pens.

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This study was sponsored by Sanofi.

DDL Now Offering ISO Testing for Needle-based Injection Systems

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Differences between average values of the actual dose from the isp dose were statistically 116081 at the middle 40 U dose SS: Needle-based injection systems for medical use. National Center for Biotechnology InformationU. Needle-based injection systems Status: This ensures that you are always up-to-date and saves you both time and money. 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.

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.

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. We use cookies to make our website easier to use and to better understand your needs. The line near the middle of each box represents the median 50th percentile.

All measurements were performed by a single investigator to eliminate potential investigator variability.

Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. Read more about subscriptions. This article has been cited by other articles in PMC. Reusable and disposable insulin pens for the treatment of diabetes: The dose tested and the corresponding ISO limits are 1160-1 by the horizontal lines in each plot.