Developing innovative medical device technology is a high-risk operation.
That’s why start-up ventures to large established medical devices manufacturers use Medistri’s laboratory testing services to deliver accurate and reliable results for all their testing needs. Patient safety is predicated on the medical device’s specific structural materials and also on a comprehension of the compounds and residuals that might be produced or recognised throughout the supply chain. Medistri’s laboratory team aggregates all data, outlines findings, and recommend risk management proposals in a transparent, detailed, and precise manne — Allowing you to bring your safe product to market quickly.
👉 Medistri’s Laboratory Microbiological Testing Stack for Medical Devices:
✅ Bioburden Endotoxin Testing:
Many single-use medical devices are terminally sterilised using EO, Steam, or radiation technologies. Manufacturers are required to validate the sterilisation process and typically require both bioburden and sterility testing. Understanding and controlling the bioburden of a product is a prerequisite for any proper sterilisation.
✅ Cytotoxicity Testing:
The cytotoxicity testing is used to determine the toxicity of medical devices and materials. The test is carried out on all medical devices that come into touch with patients, as well as raw materials and devices that will be undertaking cleaning validation. Cytotoxicity testing evaluates whether a material can affect living cells. Medical Device Manufacturers are required to show that their devices are not cytotoxic in accordance with ISO 10993–5.
✅ Gravimetric Residue Analysis (ASTM F2459):
This test technique is for determining the quantity of residue produced from medical device metallic components following extraction with aqueous or organic agents. Gravimetry by itself is not accurate enough to determine cleanliness, hence it’s routinely paired with other analytical methods like GC-MS and FTIR.
✅ Total Organic Carbon (TOC) Testing:
TOC (Total Organic Carbon) Testing helps medical device manufacturers in the following areas:
Ensuring USP and EP standards for water quality are met
Validating the cleanliness of reusable and singe-use medical devices.
👉 International Standards Organization
- ISO 10993–5
- ISO 10993–12
- ISO 11731–1:2018
- ISO 11135
- ISO 19227
👉 United States Pharmacopeia
- USP <1>
- USP <61>
- USP <62>
- USP <85>
- USP <87>
- USP <161>
- USP <643>
- USP <645>
- USP <1231>
👉 Other Standards
- ANSI/AAMI ST72
- SM 5310C
- ASTM F2459–18
- ASTM F2847–17
- ASTM F3127–16
- ASTM F3208–20
🎯 To learn more about Medistri’s Laboratory’s Microbiological Testing Stack for Medical Devices, visit on our website at www.medistri.swiss or directly contact our team at contact@medistri.swiss.
- The Medistri Team
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