IC- Innovation in Biomedical              
              

Density and Porosity (ISO/IEC 17025 accredited)

Assuring the safety of materials used in the development of medical devices includes a critical assessment on physico-chemical of the manufactured products. Our laboratory offers comprehensive physico-chemical characterization services according to standard documents such as ISO and ASTM.

Carbon and Sulfur Analysis (ISO/IEC 17025 accredited)

The acceptable bio-capability and physical and mechanical properties primary steel and finished metals product especially medical devices are highly depending on the level of impurity of the element such as carbon and sulfur. Our laboratory offers a redefined way of determining carbon and sulfur in metals, ores and other inorganic materials using a robust Carbon & Sulfur Analyzer.

High Definition Live Science Imaging

Industrial Centre of Innovation in Biomedical supports the imaging needs of the scientific and research communities with advanced innovation and technical expertise for visualization, measurement and microstructural analysis. The testing includes Fluorescence & Confocal Microscopy; Variable Pressure Scanning Electron Microscopy (VPSEM).

Optical Properties of Thin Film

Our team provides a central aspect of optical thin film characterizations via multiple optical techniques such as reflectometry, transmission spectrometry, ellipsometry as well as optical plane imaging through microscopy. These techniques are used with suitable optical mathematical model related to the tested material such as Cauchy, Lorent-Lorenz, Bruggermann and Drude as well as Fresnel optical approximation to truly define the desired optical properties.

Chemical Analysis by Fourier Transform InfraRed (FTIR) Spectroscopy (ISO/IEC 17025 accredited)

This is a non- destructive method to analyze the chemical functions by using the vibration detection that correspond to the chemical bonding of a particular material.

The test method is in accordance with ASTM E1252 – 98 and ASTM E573-01 for Qualitative Measurement of IR Spectrum.

Elemental Analysis through Energy Dispersive X-Ray (EDX) (ISO/IEC 17025 accredited)

Energy dispersive X-ray spectroscopy (EDS or EDX) is an analytical technique used for the elemental analysis or chemical characterization of a sample based on the principle of an interaction of some source of X-ray excitation with sample's elements.

Our energy dispersive spectrometer microanalysis system coupled with Field Emission Scanning Electron Microscope can execute the material identification and weight percentage determination as well as standard quantitative analysis of mass fraction.

Sterility

We provide sterility testing which is based on ISO 11737-2:2009 guideline using direct immersion method for products in the form of solid dosage, powders, ointments and creams.

In-Vitro Cytotoxicity

Our laboratory provides the In Vitro Cytotoxicity assessment through the colorimetric assay of MTT assay (tetrazolium dye) and Alamar Blue Assay.

Polymer Degradation

Our polymer degradation analysis and studies shall include degradation product analysis (identification and quantitation), polymer degradation experimental design and extractable and leachable testing evaluation of functional material properties during degradation. Testing that may be employed to study the effect of degradation process on the polymeric may involve GPC, SEM, FTIR, TGA and UV-vis.

Ceramic Degradation

To ensure the safety profiles of the resorbable ceramic based medical devices, confirmation through the degradation and dissolution are performed to confirm that the ceramic products are free from processing contaminants and residuals, such as machining oils and cutting fluids as well as self-leaching ions.

Advanced Materials Testing Laboratory experts are happy to support manufacturers facing the challenge, providing testing and offering regulatory expertise during the entire medical life cycle.

Metal Corrosion

Corrosion testing determines the resistance of materials to corrosion under certain environmental conditions, including temperature, humidity and salt water. ICI Biomedical offers a full array of corrosion testing services to ensure the performance of metals and coatings.

The corrosion test is based on the ISO 10993-15 Biological Evaluation of Medical Devices, Part 15 - Identification and Quantification of Degradation Products from Metals and Alloys.

Biomechanical

Biomechanical considerations for medical devices include an implant's ability to withstand tensile, compressive, and shear forces, variations and degrees of freedom, and the mechanical properties of the device such as elastic modulus, yield strength, and elongation to failure.

Materials such as metals and alloys, ceramics, and polymers are used in the development of medical devices especially in the orthopaedic area.

To fulfil the suitability assessment covering diversity of medical devices, we are in the process of developing 15 methods of biomechanical testing that covers dental implants, hip prosthesis, spinal, osteosynthesis, cranio and maxilla facial and knee implants.

Contact Us

Tel: 04 – 4017100

Email: kartini@sirim.my

Email: ici_enquiry@sirim.my

Address

Industrial Centre of Innovation in Bio Medical

SIRIM Advance Material Research Centre (AMREC)

Lot 34, Jalan Hi-Tech 2/3, Kulim Hi Tech Park,

09000 Kulim, Kedah.

Toll Free: 1-300-88-7035
General Line: 603-5544 6000
Customer Service & Support : 603- 5544 6542 /6518 / 6692/ 6693 /6762
Email: web@sirim.my
Customer Service Operating Hours:
Monday – Thursday: 8:30 am to 5:00 pm
Friday : 8:30 am to 4:45 pm 
Lunch break
Monday – Thursday : 1.00pm  -  2.00pm
Friday :12:30pm -  2:45pm

For more details, let us hear from you.

 



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