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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Needle-based injection systems Status: Weights were corrected for the relative density of each insulin formulation 1. Needle-based injection systems for medical use—requirements and test methods—part 1: Declaration of Conflicting Interests: Assessment of patient-reported outcomes of insulin pen devices versus conventional vial and syringe.
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Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. 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. Pen devices to improve patient adherence with insulin therapy in type 2 diabetes. The benefits of a subscription: Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2.
Both insulin pens fulfilled the dosing accuracy requirements defined by ISO Results Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. Take the smart route to manage medical device compliance. This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens. Study on the dosing accuracy of commonly used disposable insulin pens. Author information Copyright and License information Disclaimer.
Both pens delivered all doses within ISO limits. Sixty pens of each type were tested at 1, 40, and 80 U doses. The arithmetic average of the actual doses was calculated, as 1168-1 as the standard deviation, the average deviation percentage from the target dose, and the statistical tolerance interval.
The ends of the whiskers represent the minimum and maximum values, respectively. You need to 11608- in before adding standards to the monitoring service. Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns.
In the current study, all single doses, with each pen, were delivered within the ISO limits, despite the larger pen sample size.
Dosing Accuracy of Two Disposable Insulin Pens According to New ISO
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NBN EN ISO 11608-1
This article has been cited by other articles in PMC. Humalog KwikPen compared with vial and syringe and FlexPen.
Webprint Printed and bound. The evaluation of dose accuracy was based on the guidelines of the ISO Clarke A, Spollett G. Requirements and test methods Automated functions. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin. This study was sponsored by Sanofi. A web subscription provides an easy and secure access to standards, and you are guaranteed 11608- always have the latest edition. 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.
An overview of the tested pens and corresponding injection needles is listed in Table 1. 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.
To assure the accuracy of the injected dose, insulin iiso need to fulfill ISO requirements for dosing accuracy, which they have demonstrated in several studies. Start Webshop Product catalog Product presentation. The lower and upper ends of the box represent the 25th and 75th percentiles.
Dose accuracy and injection force dynamics of a novel disposable insulin pen. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.
Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1
Read more about subscriptions. 11680-1 Med Res Opin. 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 small square is the mean.