We provide comprehensive biological evaluation services for medical devices, ensuring compliance with ISO 10993: Biological Evaluation of Medical Devices. Our fully accredited laboratory specializes in chemical, microbiological, and toxicity analysis, delivering precise testing to meet regulatory requirements and safeguard product safety.

As a SAMM-accredited facility, we adhere to ISO 19227: Implants for Surgery – Cleanliness of Orthopedic Implants, offering specialized testing to verify the cleanliness and biocompatibility of orthopedic implants. Our testing capabilities include:

> Non-Polar Organic Compounds (Total Hydrocarbon): In House Method MY/STP/433 Based on ISO 10993-12:2012 and ISO 9377-2:2000

> Polar Organic Compounds (Total Organic Carbon): In House Method MY/STP/434 Based on ISO 10993-12:2012 and EN 1484:2002

> Particulate Residue: In House Method MY/STP/437 Based on ASTM F2459-12

> Polar Inorganic Compounds (Metallic Impurities): In House Method MY/STP/432 Based on ISO 10993-12:2012 and ICP-MS

> Residual Acid (As Nitric Acid): In House Method MY/STP/438 for Quantification of Residual Acid by Conductivity Measurement

> Endotoxin: Multi-test Limulus Amoebocyte Lysate (LAL) kit

> Determination of population of microorganisms on products (Estimation of product bioburden): In House Method MY/STP/430 Based on ISO 11737-1:2018

> In Vitro-Cytotoxicity: In House Method MY/STP/431 Based on ISO 10993-12:2012 and ISO 10993-5:2009 (Annex C: MTT assay)

We also offer Sterilization Evaluation Services, including:

Ethylene Oxide Sterilization Evaluation:

Analytes: Ethylene Oxide, Ethylene Chlorohydrin (2-chloroethanol), Ethylene Glycol
Method: In House Method MY/STP/435 Based on ISO 10993-12:2012 and ISO 10993-7:2008

Sterility Assurance Analysis:
> Sterility Testing: BP 2020 Appendix XVI A.
> Determination of population of microorganisms on products (Estimating of product bioburden): In House Method MY/STP/430 Based on ISO 11737-1:2018

Our method development expertise includes:

> Development of chemical, microbiological, and toxicity testing methods.

> Initial validation to ensure accuracy, reproducibility, and suitability for intended use.

> Outgassing Analysis: Determination of composition, concentration, and evolution profiles of gases released from medical devices.

Partner with us for reliable, industry-compliant testing solutions tailored to your needs.