Strict control of microorganisms is an important quality control requirement in the R&D and production for medical device products (especially for non-active medical device products). Microbial control occupies an important position in the quality requirements of medical devices, and is also an important parameter reflecting the quality control system of medical device production. Most medical device products that come into contact with the human body require microbial limit testing.

Microbiological Testing

• Microbial limit
• Initial contamination bacteria test
• Sterility test
• Bacterial endotoxin test
• Bioburden
• Fungicide efficacy evaluation
• Bacteriostatic test

Basis of Testing Method

Microbial Limit	Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, GB 15979, GB/T 19973, ISO 11737
Sterility test	Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ISO 11737
Endotoxin test	Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, YY/T 0616, GB/T 14233.2
bioburden	ISO 11737-1
Fungicide efficacy evaluation	US Pharmacopoeia, GB 15979, Technical Specification for Disinfection
Bacteriostatic test	US Pharmacopoeia, GB 15979, Technical Specification for Disinfection

Service Process

Our Advantages

Whole Industry Chain Services｜Provide full industry chain technical services, including R&D support, safety evaluation and testing, registration, clinical, quality management system, etc.

Professional Technical Team| A team of experts in the fields of medical device regulations, registration, medicine, toxicology, statistics, biological evaluation, chemical analysis, microorganisms, etc., with comprehensive technical service capabilities

Professional Laboratory｜Own several professional laboratories, including chemical analysis lab, materials lab, microorganisms lab, environment lab, efficacy evaluation lab, animal safety evaluation lab, etc.

Rich Industry Experience｜Successful cases on safety assessment, registration and clinical services in active, non- active and IVD; Rich experience in implantable degradable products, medical beauty products, oral materials, cavity stents, assisted reproductive products and orthopedic ophthalmology field.

If you have any needs or questions, please contact us attest@cirs-group.com.