Biocompatibility

The biological evaluation of medical devices is an essential step in their developement. Therefore any potential risk for the use of the devices in humans should be investigated thoroughly. For this purpose BSL BIOSERVICE provides the complete panel of tests for detecting possible adverse local or systemic effects.

Having more than 24 years of experience in the field of biocompatibility testing, BSL BIOSERVICE does not only offer the biological studies according to the matrix of ISO 10993-01 but also helps to create individual testing strategies, which are often requested for new biomaterials and manufacturing methods.

Biocompatibility test panel:Implant Device

  • Cytotoxicity

    • Growth inhibition
    • Direct cell contact
    • Agar diffusion test
    • Colony forming assay

  • Irritation

    • Dermal irritation
    • Intracutaneous irritation
    • Occular irritation
    • Oral mucosa irritation test
    • Penile irritation test
    • Rectal irritation test
    • Vaginal irritation test

  • Sensitization

    • Maximisation test (Magnusson / Kligman)
    • Closed patch test (Buehler)
    • Local lymph node assay (LLNA)

  • Toxicity

    • Single dose toxicity
    • Repeated dose toxicity (subacute, subchronic and chronic)
    • Reproduction toxicity
    • Partnered Services: Inhalation toxicity, Carcinogenicity in vivo

  • Genetic Toxicology

    • Genetic Toxicology using Prokaryotics
      • Ames test (OECD 471) Salmonella typhimurium, Escherichia coli
    • Genetic Toxicology using Eukaryotics
      • Chromosomal aberrations (OECD 473): V79 cells or human lymphocytes
      • Mouse lymphoma assay (OECD 476)
      • HPRT assay (OECD 476)
      • Micronucleus assay in vitro (Draft OECD 487)
      • Micronucleus assay in vivo (OECD 474)
      • DNA-repair: UDS assay in vitro / ex vivo (OECD 486): rat primary hepatocytes

  • Haemocompatibility

    • In vitro assays
      • Static systems
      • Dynamic systems e.g. Chandler system
    • Biological endpoints
      • Thrombosis
      • Coagulation
      • Platelets
      • Hemolysis
      • Complement system

  • Functional Implantation studies

    • Soft tissue e.g.

      Application systems

      Breast prostheses

    • Bone e.g.

      Tissue replacement

      Orthopedic prostheses

    • Blood e.g.

      Stents

  • Local Tolerance

    • Histocompatibility
      • Subcutaneous tissue
      • Muscle
      • Bone

  • Non-Clinical Safety tests in vivo

    • Customized infection studies
    • Irwin screen

  • Physico-Chemical tests (partnered service)

    • Identification and quantification of degradation products
    • Chemical characterization of materials
    • GC / MS-fingerprint
    • Accelerated aging
    • Packaging validation
    • EO residue determination
    • Analysis for heavy metals
    • Investigation of silicone material