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Hemolysis

(Blood Pump)

Ensuring the safety and biocompatibility of blood-contacting medical devices requires precise evaluation of hemolysis — the damage of red blood cells under mechanical stress. Hemolysis testing is not just a regulatory requirement; it is a critical step in validating device performance and patient safety.

At our testing facility, we conduct hemolysis assessments in full compliance with ASTM F1841, ISO 18242, and ISO 14708-5:

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  • ASTM F1841:
    Provides standardized methods for measuring hemolysis in blood pumps, ensuring reproducible and clinically relevant results.

 

  • ISO 18242:
    Establishes protocols for extracorporeal blood-contacting devices, focusing on hemocompatibility and performance under simulated physiological conditions.

 

  • ISO 14708-5:
    Defines requirements for implantable circulatory support systems, including hemolysis evaluation as part of long-term safety and reliability testing.
  • Patient Safety:
    Minimizing hemolysis reduces risks of anemia, organ stress, and secondary complications.

 

  • Regulatory Compliance:
    Adherence to international standards accelerates approval processes and market entry.

 

  • Device Optimization:
    Detailed hemolysis data informs design improvements, from impeller geometry to surface properties.

 

By combining advanced test rigs, precision analytics, and strict adherence to global standards, we help manufacturers demonstrate the safety and reliability of their blood-contacting devices. Partnering with us means confidence in both compliance and innovation — ensuring that life-saving technologies reach patients with proven performance.

Workflow

How we work:

A clear, three-step workflow—ensures a reliable, data-driven progress.

Feasibility
Study

Performance
Charaterization

Full approval-
relevant studies

Your journey with ac.biomed:

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1.
Service Request

2.
Information Provision

3.
NDA

1.
Service Request
2.
Information Provision
3.
NDA
4.
Service Requirements
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4.
Service Specification

5.
Quotation

6.
Order

7.
Order Confirmation
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
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8.
Test Plan

9.
Test Plan Approval

10.
Test Execution

11.
Test Report
9.
Test Plan
10.
Test Plan Approval
11.
Test Execution
12.
Test Report

Our strengths

“Outstanding service, reliable support, genuine customer closeness and open communication – this is our shared path to success.”

Quality

ac.biomed provides
quality services.

Certificate
ISO 17025
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Certificate
ISO 9001:2015
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Move forward
with ac.biomed

We want to hear from you. Whether you‘re a prospective client, a professional interested in joining our team, or simply someone interested in our work, send us a note.

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