A Precise Weigh to Assess Medical Pump Performance
Download Collaboration with B.Braun – Challenges in Testing Infusion Pumps
Ultra-High Resolution Weighing for Accurate Flow Rate Assessment and Regulatory Compliance
In the critical field of medical device manufacturing, particularly for devices that deliver life-sustaining fluids, precision is paramount. Sartorius understands the importance of ensuring accurate dose administration and sets the standard in precision lab weighing for infusion device manufacturers and testing labs.
Our Cubis® II Balances are engineered to support accurate dose administration for devices like infusion pumps, supporting your experts in Product Development, Quality Assurance, Regulatory Affairs, and more.
Be equipped with trustworthy data to uphold the integrity of medical infusion pumps throughout their lifecycle with:
Discover the Sartorius difference in ensuring the reliability and integrity of infusion pumps, where every microliter counts.
Fluid delivery performance testing for volumetric infusion, insulin, syringe, container, or peristaltic pumps.
Sartorius Cubis® II Ultra-High Resolution balances are the premier choice for infusion pump manufacturers aiming for AAMI TIR 101 compliance, offering unparalleled precision in flowrate and accuracy testing. The Cubis® II MCA66S micro balance and MCA225S semi-micro balance stand out with their advanced features, ensuring that technical experts can conduct thorough and reliable tests with confidence. The key benefits include:
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Per AAMI TIR 101 §4.2 and in IEC 60601-2-4, ISO 3696 grade 3 (or better) water or 0,9% normal saline should be used for the test solution.
The Arium® Advance EDI reliably delivers water of consistently high grade 2 water quality. Equipped with three purification stages, the system efficiently removes impurities and other contaminants from tap water.
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To be compliant with AAMI TIR 101, FDA, MDR, and GMP laboratory balances should be tested and calibrated regularly. Our Sartorius Service provides the needed certificates for your application.
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Calibration of mass standards ASTM Class 3 or OIML F1 as mentioned in AAMI TIR 101 Table 2
This kit includes a moisture trap to saturate the air surrounding the beaker, a weighing system adapter, multiple beakers, and a pre-pierced cover for...
A monolithic weighing system that empowers flow & accuracy. Cubis® II balances offer exceptional repeatability, high capacities, fast stabilization, and low weighing drifts under real-life conditions.
Increase your efficiency without compromising between long testing periods and high precision. Our Cubis® II High-Capacity Micro balances are designed to let you run a maximum number of shots through high capacities (61g) and a readability of 1 µg with minimum interruption.
The Cubis® II balances achieve high and accurate data transfer rates of 10 Hz (10 measuring values per second) and can achieve even higher transfer rate with specific adjustments.
Discover the precision of Sartorius Cubis® II balances in ensuring accurate dosing rates for infusion pumps
Understand how the Cubis® II Ultra-High Resolution balances (5-digit and 6-digit) perform under real lab conditions and how they perform against a com...
Guidelines for precise calibration of lab weights to maintain test equipment accuracy per OIML R111-1
Understand Sartorius calibration certificates for NAWI, aligned with EURAMET cg-18, in our detailed white paper.
Advantages and highlight of a coated draft shield for lab balances
Overview of infusion pump testing and innovations.
Dive into medical infusion technology with Lucas Foerster explaining our in-depth exploration of precision balances like Cubis®️ II, the critical role of infusion pump testing, and the exciting future trends in drug delivery systems. Learn how dose accuracy, regulatory compliance with standards like ISO 60601-2-24, and advancements in medical devices are shaping patient care.
For accurate fluid delivery testing in infusion pumps, it's crucial to select a balance that aligns with IEC 60601-2-24 and TIR 101 standards. Key considerations include:
Opting for the highest balance capacity and resolution ensures reliable pump performance testing.
The Sartorius Cubis® II Balances assist microvolume pump manufacturers in testing flow rates and accuracy. For evaluating microvolume pumps, we suggest employing the latest Cubis® II Ultra-High Resolution Balances, offering resolutions of 0.01 mg (semi-micro balance with a 220 g capacity) or 0.001 mg (high-capacity micro balance with a 61 g capacity). These balances deliver rapid and stable readings and are equipped with an integrated ionizer and a conductive coating on the draft shield to eliminate static interference.
The Cubis® II balances feature a monolithic weighing system that supersedes the traditional 150+ piece systems, significantly diminishing weighing drift and establishing them as the optimal choice for precise applications.
AAMI TIR 101:2021 recommends ASTM Class 3/OIML Class F1 weights. The nominal mass value of your weight should be more than 80% of the maximum capacity of your weighing instrument. Proof of traceability to national standards should be available.
Shop Now F1 Weight Set 1 mg – 5 kg with DAkks Certificate
The report from the EMPIR Metrology for Drug Delivery project details various calibration methods for assessing the response or delay time of drug delivery devices using Newtonian liquids for ultra-low flow rates from 5 nL/min to 100 nL/min. The methods explored include gravimetric, optical (meniscus tracking and pendant drop), microPIV/microPTV, and displacement methods. Each method is traceable to specific standards and involves unique model functions and uncertainty components such as volume, time, radius, and stability of motion.
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Read this article and learn form the testing process for medical infusion pumps, including flow rate testing. Lucas Foerster also spotlights key lab weighing innovations that are helping drug delivery system manufacturers meet the demands of a stringent regulatory environment.
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