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     Certification
Certificated by China National Accreditation Service for Conformity Assessment
Certificated by China National Accreditation Service for Conformity Assessment
Certificated by China Metrology Accreditation
Certificated by State Food and Drug Administration
 
About Us

     Shanghai Biomaterial Research and Test Center (SBRTC) was founded in June 1989 by Shanghai Sci-Tech Committee, which was affiliated to Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine. SBRTC has devoted to the biocompatibility test, evaluation and research on biocompalibility and standardization of the medical devices and biomaterials.

      As one of the earliest organizations that have established the standards and methods of “Biological Evaluation of Medical Devices” in China, SBRTC is a highly prestigious institute worldwide and has the best ability to perform biological tests of medical devices and products. SBRTC has certificated by China National Accreditation Service for Conformity Assessment (CNAS),State Food and Drug Administration (SFDA) and China Metrology Accreditation (CMA). And SBRTC was authorized to meet the ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories to execute the biological evaluation according to the ISO 10993.

      SBRTC has built a platform of testing and counseling service for home and abroad clients of different industries,such as plastic,rubber,chemical,ect. because center depends on technique of university and hospital, and has been provided with advanced laboratory apparatus and professional technologist.

Research focus MORE >>

Research on biological safety in vivo and mechanism of cellular damage of nanoparticles
----Study on distribution,metabolism and eccrisis of Nanoparticles in vivo

Basical study on Application of dental medical devices and materials
----Research on ion dissolution and biological effect of dental metals

Research on interaction between medical devices or biomaterials and organism
----Study on hemocompatibility of medical devices and biomaterials

Study on the biodegradation and safety evaluation of biodegradable materials
----Comparison of biodegradation between in vivo and in vitro of biodegradable materials

      Contact us

Address: 201-301, Building 2, № 427 Jumen Road, Shanghai, China

Zip code: 200023

Tel: 0086-21-63034903

Fax: 0086-21-63011643

Contact person: Zhewei Huang

Emailbiomatercenter@163.com

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HTTP://WWW.SGST.CN
 
  Service Item MORE >>
·Test for reproductive toxicity
   ————Prenatal Developmental Toxicity Study,Reproduction/Developmental Toxicity Screening Test
·Test for in vitro cytotoxicity
   ——— Extracts, Direct contact, Indirect contact
·Test for sensitization
   ———Guinea pig maxization test, Closed-patch test, local lymph node assay
·Test for irritation
   ———Skin irritation test, Ocular irritation test, Mucosa irritation test (Oral, Rectal, Vaginal, Penile), Intracutaneous (intradermal) reactivity
·Tests for systemic toxicity
   ———Acute,sub-acute,sub-chronic, chronic (routes including oral、intravenous、intraperitoneal、implantation、intradermal、subcutaneous 、intramuscular)
·Pyrogenicity test
   ———Rabbit pyrogen test, TAL test
·Test for genotoxicity
   ———In Vitro Mammalian Chromosome Aberration Test, Micronucleus Test of Bone Marrow Cell, Salmonella Typhimurium Reverse Mutation Assay, In Vitro Mammalian cell gene mutation test
·Test for carcinogenicity
   ———Syrian Hamster Embryo Cell Transformation Assay
·Test for local effects after implantation
   ———Subcutaneous、Muscle、Bone
·Tests for interactions with blood
   ———Thrombosis, Coagulation, Platelets, Hematology, Complement system
·Immunotoxicity test
   ———cell immunity,humoral immunity
· Bio-degrade test
   ———polymer、ceramics
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