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TRANSCRIPT
International Organization for Standardization
Forms a bridge between public and private sectors
ISO
ISO 10993 Published in 1995 Series of standards for biological evaluation of medical devices… 20-part structure
ISO 10993-1 Framework for planning a biological evaluation Evaluation of existing data and identification of gaps Assessment of biological safety
ISO 10993-1
Preference for: a. In vitro models b. material / chemical
characterization
ISO 10993-1
Device categories a) surface, external
communicating and implant b) contact mode c) duration of contact
ISO 10993-1
Framework for a biocompatibility testing program Not a formal checklist
ISO 10993-18 Materials directly influence biocompatibility
a) surface chemistry and topography
b) extractable chemical compounds
c) particulates
ISO 10993-18 Equivalence of material Predict biological response Screening new materials Evaluate manufacturing process
Biocompatibility Testing of PPM’s Products
Device Category: Surface Device
Cytotoxicity Sensitization Irritation Acute systemic toxicity
Cytotoxicity
ISO 10993-5 In Vitro test Ideal for screening Agar Diffusion
Agar Diffusion Test
FDA Standard Quantitative test for cytotoxicity (ISO 10993-5) MTT Cytotoxicity In Vitro test Extract of the material
MTT Cytotoxicity
Sensitization ISO 10993-10 In Vivo Test Reactions are delayed, not localized and dose independent
Kligman Maximization Guinea pigs Day 0: Intradermal injection Day 7: Topical at same site Day 23: Topical at new site Days 23 – 25: Scored ISO 10993 scoring system
Irritation
ISO 10993-10 In Vivo Test Single exposure Reaction is immediate
Intracutaneous Injection
Rabbits Direct or extracts and control materials Scored over 72 hr period ISO 10993 scoring system
Systemic Toxicity
ISO 10993-11 Toxic effect:
a. distant from exposure site b. biological systems
Acute Systemic Injection
Mice Single intravenous and/or intraperitoneal injection Observed over 72 hr period Compared with controls
Material-Mediated Rabbit Pyrogen
Rabbit Single intravenous injection Body temperature: 30 min. intervals for 3 hour period Temp. increase limit: 0.5 ºC
Summary
Biocompatibility is vital PPM evaluates potential toxicity according to ISO 10993, parts 5, 10 & 11
