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norms
and
standards

Overview

Standards &
Regulatory Compliance

Meeting international standards is critical for market success.
ac.biomed translates complex regulatory requirements into reliable, standard-compliant testing that accelerates approvals and builds trust.

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ASTM F 1841

(Blood Pump)

ASTM F 3067

(Stents)

FDA Guidance

(Heart Valve · Oxygenator)

ISO 14708-5

(Blood Pump)

ISO 15674

(Cardiotomy Reservoir)

ISO 15675

(Arterial Filters)

ISO 18193

(Cannula)

ISO 18242

(Blood Pump)

ISO 25539

(Stents)

ISO 5840

(Heart Valve)

A New Chapter
with Eurofins

As we have joined the Eurofins network, this website will be closing on December 31, 2026.

All content and information will be available on our new website.

Thank you for your trust and continued support. We look forward to continuing to provide you with reliable testing services as part of the Eurofins network.