Chemical Analysis

Analyse chemical composition that may have been introduced to the medical devices during the manufacturing, packaging, shipping, and routine sterilisation process. This includes their potential as extractables and leachables that may impose serious adverse effects to the patients upon direct contact.

  • Chemical Degradation
  • Chemical Migration
  • Chemical Permeation
  • Residual Ethylene Oxide                           

Physical Evaluation

The study of the medical devices' physical performance characteristics under varying environmental conditions. Physical evaluation is a part of the early stages of the medical devices testing in advance to biocompatibility.

  • Accelerated Shelf-life Testing

Biocompatibility Evaluation


Product safety tests for medical devices that look at the human body's biological effect resulting from the direct contact with the devices' materials. Complete range of the biological evaluation testings for medical devices are mandated in ISO 10993. Additional tests for evaluating the devices' performance from the biological/microbiological perspectives are also available.

  • Cytotoxicity
  • Genotoxicity: Chromosomal Aberration Test
  • Hemocompatibility
  • Irritation
  • Sensitization
  • Systemic Toxicity
  • Antibacterial Surface
  • Bioburden
  • Endotoxin
  • Pyrogen
  • Sterility

Viral Penetration                         

Contact Us

Tel: 03-55446960



Industrial Biotechnology Research Centre (IBRC),

Block 19,

SIRIM Berhad,

No. 1, Persiaran Dato’ Menteri,

Seksyen 2, PO BOX 7035, 40700, Shah Alam, Selangor.

Toll Free: 1-300-88-7035
General Line: 603-5544 6000
Customer Service & Support : 603- 5544 6542 /6518 / 6692/ 6693 /6762
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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