ISO 11608-1 PDF

Tygolkree Click to learn more. Humalog KwikPen compared with vial and syringe and FlexPen. To assure the accuracy of the injected dose, pens need to fulfill ISO requirements for dosing accuracy, which they have demonstrated in several studies. Worldwide Standards We can source any standard from anywhere in the world. J Diabetes Sci Technol.

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Abstract Background The pen injection format, typically used for insulin administration, has been adapted for the injectable, noninsulin diabetes therapy pramlintide. All pens were stabilized under testing conditions for 4 h prior to testing. One site used a compression load cell Zwick device to test pens; one site performed tests manually.

Injection-force testing was performed using a Zwick device. Mean percentage of dose accuracy was The average injection force across both pens did not exceed 7 N regardless of needle size. Keywords: accuracy, hyperglycemia, pramlintide, reproducibility, type 1 diabetes, type 2 diabetes Introduction The first pen injection device was launched in 1 for the administration of insulin to patients with type 1 or advanced type 2 diabetes.

Since then, pens have continued to gain in popularity, primarily outside the United States; however, pen use in the United States now appears to be increasing. Pen properties associated with improved ease of use include portability and ease of reading, ease of adjustment, ergonomic design, sturdiness, and differentiation between multiple pens for patients using more than one injectable medication.

Low injection force pens allow patients to inject the full dose by applying a low and steady pressure without experiencing hand or grip fatigue. A survey of studies between and assessing patient-reported outcomes of pen versus vial and syringe showed substantial preferences for the pen. Durable refillable pens are used repeatedly, and spent drug cartridges are replaced with new ones as needed.

Patients with diabetes are deficient in both insulin and amylin. Pramlintide, like amylin, slows gastric emptying, suppresses inappropriate postprandial glucagon secretion, and increases satiety.

These effects complement those of insulin to help circulating glucose concentrations stay within the normal range, thus avoiding hyperglycemia and, over the long-term, lowering hemoglobin A1c.

Patients using pramlintide require two to four injections per day based on eating habits in addition to their injections of rapid-acting insulin. Thus, a drug delivery system pen that increases ease of use and accuracy may be beneficial to patients. This article describes the design features, dose accuracy, and dose injection force of the pramlintide pen delivery system. Methods Design Features Two sets of dosing options are available for the pramlintide pen.

Adjustable dosing allows patients to use less pramlintide if they better tolerate lower than higher doses or require gradual titration to improve tolerability. The fixed dose design differs from that used in insulin pens, which are designed to deliver a continuous drug dose across a wide range. Both pramlintide pens allow use of 29, 30, or 31 G type A needles, and the pens may be used for up to 30 days, depending on dose size and injection frequency.

Pens have a maximum diameter of Three key design features help ensure a high level of dosing accuracy. A stroke sleeve moves the toothed rod forward by a precise distance when the dosage knob is depressed, and a guiding sleeve with interlocking teeth prevents the toothed rod from traveling backward data on file, Amylin Pharmaceuticals, Inc.


CSN EN ISO 11608-1

Find Similar Items This product falls into the following categories. The ends of the whiskers represent the minimum and maximum values, respectively. Curr Med Res Opin. International Organization for Standardization. Published online Jul If you need to be able to add jso to the monitoring service, you must register as a user with your own username and password. This service is not available if you are a URL user where you do not log in with an email address. The evaluation of dose accuracy was based on the guidelines of the ISO Search all products by.


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ISO 11608-1.pdf


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