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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All measurements were performed by a single investigator to eliminate potential investigator variability. In the current study, all single doses, with each pen, were delivered within the ISO limits, despite the larger pen sample size.

Study on the dosing accuracy of commonly used disposable insulin pens. This article has been cited by other articles in PMC.

The faster, easier way to work with standards. This could not be confirmed according to the new standard in the current study where equivalent results were obtained with the 2 pens. This ensures that you are always up-to-date and saves you both time and money.

Requirements and test methods Automated functions. National Center for Biotechnology InformationU. The balance was zeroed before each dose of insulin was deposited and weighed. Parenteral infusion equipment, Medical instruments, Medical equipment, Drug administration, Containers, Performance, Injection instruments, Measuring cylinders, Specification approvalPerformance testing, Surgical needles, Syringes, Injection guns.

The ends of the whiskers represent the minimum and maximum values, respectively. Learn more about the cookies we use and how to change your settings. Clarke A, Spollett G. Dosing accuracy of commonly used disposable insulin pens. Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen. An overview of the tested pens and corresponding injection needles is listed in Table 1.

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You may experience issues viewing this site in Internet Explorer 9, 10 or Worldwide Standards We can source any standard from anywhere in the world. Expert Opin Drug Deliv. Needle-based injection systems for medical use—requirements and test methods—part 1: You may find similar items within these categories by selecting from the choices below:.

Pen Injektoren ISO

Open in a separate window. The lower and upper ends of the box represent the 25th and 75th percentiles. For each dose application, a new injection needle was used and an air shot included before the injection.

Please download Chrome or Firefox or view our browser tips. Humalog KwikPen compared with vial and syringe and FlexPen. Weights were corrected for the relative density of each insulin formulation 1. NOK 1 ,00 excl. Click to learn more. Differences between average values of the actual dose from the target dose were statistically significant at the middle 40 U dose SS: 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.

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. Search all products by. 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. Start Webshop Product catalog Product presentation.

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BS EN ISO 11608-1:2015

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. Support Center Support Center. 16108-1 review our privacy policy. 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 1160-1, the average deviation between actual and target dose and the standard deviation remained very low for both pens.

Penfornis A, Horvat K. Accept and continue Learn more about the cookies we use and how to change your settings. This service is not available 116081 you are a URL user where you do not log in with an email address.

DDL Now Offering ISO Testing for Needle-based Injection Systems

Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin. You need to log in before adding standards to the monitoring service.

The line near the middle of each box represents the median 50th percentile. The benefits of a subscription: Declaration of Conflicting Interests: The moment new editions of the standards you monitor are released, changes are made, or appendixes are published, you will be alerted by email.

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