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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Association for the Advancement of Medical Instrumentation

J Diabetes Sci Technol. 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. The ends of the whiskers represent the minimum and maximum values, respectively.

For each dose application, a new injection needle was used and an air shot included before the injection.

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

The small square is the mean. Learn more about the cookies we use and how to change your settings.

However, the difference in dosing accuracy between SS and FT cannot be considered clinically relevant. Start Webshop Product catalog Product presentation.



Weights were corrected for the relative density of each insulin formulation 1. Penfornis A, Horvat K.

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Published online Jul Please download Chrome or Firefox or view our browser tips. Requirements and test methods. Please review our privacy policy. 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. Both insulin pens fulfilled the dosing accuracy requirements defined by ISO Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen.

Both insulin pens showed excellent dosing accuracy at all dosage levels Figure 2. NOK 1 ,00 excl. Needle-based injection systems for medical use—requirements and test methods—part 1: You need to log in before adding standards to the monitoring service.

The balance was zeroed before each dose of insulin was deposited and weighed. A web subscription provides an easy and secure access to standards, and you are guaranteed to always have the latest edition. Webprint Printed and bound. Pen devices to improve patient adherence with insulin therapy in type 2 diabetes.


Needle-based injection systems Status: Accept and continue Learn more about the cookies we use and how to change your settings. However, contrary to the new ISO Study on the dosing accuracy of commonly used disposable insulin pens.

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 current results confirm the excellent dosing accuracy for SS 47 – 11 and FT 714 demonstrated in previous studies performed according to ISO Read more about subscriptions. 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. 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.

Target doses of 1 U minimum40 U middleand 80 U maximum were ejected and measured for each pen. International Organization for Standardization.