Biocompatibility Testing

Product Safety Labs (PSL) can assist in the development of data necessary to support the regulatory requirements of the Medical Device industry.  ISO 10993 describes the general principles governing the biological evaluation of medical devices within a risk management process.  The ISO 10993 guideline is generally accepted worldwide. 

Biological Evaluation According to ISO 10993

Product Safety Labs offers biological studies according to the matrix of ISO 10993-1 and can also create individual customized testing strategies. Evaluation depends on the category of the medical device in accordance with the nature of the devices' use pattern and the duration of contact. 

Biocompatibility Tests

• Cytotoxicity

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

• Irritation

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

• Sensitization

  • Maximization test (Magnusson & Kligman)
  • Closed patch test (Buehler)
  • Local lymph node assay (LLNA)

• Toxicity

  • Single dose toxicity
  • Repeated dose toxicity (subacute, subchronic and chronic)
  • Reproductive toxicity
  • 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)
    • Hypoxanthine-guanine Phosphoribosyl Transferase assay (HPRT) (OECD 476)
    • Micronucleus assay in vitro (OECD 487)
    • Micronucleus assay in vivo (OECD 474)
    • DNA-repair: UDS assay in vitro / ex vivo (OECD 486): rat primary hepatocytes

• Hemocompatibility

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

• Functional Implantation Studies

  • Soft tissue
    • Application systems
    • Breast prostheses
    • Bone
    • Tissue replacement
    • Orthopedic prostheses
    • Blood
    • Stents

• Local Tolerance

  • Histocompatibility
    
    • Subcutaneous tissue
    • Muscle
    • Bone

• Non-Clinical Safety Test In Vivo

  • Customized infection studies
  • Irwin screen

• Physico-Chemical Tests

  • 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