Application Note: Challenges In Testing of Dosing Accuracy According to IEC 60601-2-24 And AAMI TIR-101

Authors: Lucas Foerster | Last updated: April 2024

Overview

Discover the precision of Sartorius Cubis® II balances in ensuring accurate dosing rates for infusion pumps. This comprehensive study, created in collaboration with B. Braun AG, delves into the challenges of meeting stringent IEC and AAMI standards, analyzing potential sources of error, and providing actionable insights for optimal pump performance testing. Learn how advanced features like the monolithic weighing system and built-in ionizers contribute to reliable measurements, making Cubis® II balances an essential tool for medical device quality assurance.


  • Document type: Application Note
  • Page count: 9
  • Read time: 6 minutes


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Key Takeaways

  • Impact of humidity and temperature on dosing rates
  • Ways to reduce measurement drift
  • Optimization of dynamic weight changes
  • Ultra high resolution Cubis® II balances support adherence to IEC 60601-2-24 and TIR-101 standards.

This Resource is Designed for:

  • Manufacturers of medical devices: Infusion pumps: large volume, syringe, ambulatory, elastomeric, insulin, PCA, enteral, implantable
  • Testing labs, accredited lab for volumes, flowrates, pumps and micropumps

Applications Supported:

  • Gravimetric testing and validation of infusion pump performance
Challenges In Testing of Dosing Accuracy According to IEC

Figure 1. Cover of Application Note
 

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