Medical devices play a crucial role in supporting public health. From simple tools like thermometers to complex medical devices such as ventilators or pacemakers, each tool has a critical role in diagnosis, treatment, and patient recovery. Due to their vital function, the testing of the quality and safety of medical devices becomes an aspect that cannot be overlooked.

How can SIG help?
As an accredited laboratory under SNI ISO/IEC 17025, SIG can assist in testing medical device products, which includes the following tests:

• Cytotoxicity 
• Skin Sensitization 
• Single & Repeated Dermal Irritation 
• Eye & Vaginal Mucosal Irritation
• Intradermal Reactivity Test (Intradermal)
• Pyrogen/Material Mediated Pyrogenicity 
• Systemic Toxicity (Acute)
• Subacute/Subchronic Systemic Toxicity 
• Chronic Systemic Toxicity 
• Endotoxin 
• Sterility 
• Syringe Needle Sharpness
• Heavy Metal (Pb, Fe, Zn, Sn, Cd)
• Cotton Absorption
• Fluorescence
• Ethylene Oxide Fumigants
• 2-Chloroethanol Fumigants 

Method of Analysis
The testing is conducted both in-vitro and in-vivo using toxicity testing methods determined by BPOM (Indonesia’s Food and Drug Authority) and OECD standards. These methods ensure that the tests adhere to regulatory requirements for safety and efficacy in medical devices.