The biological safety framework ISO10993-1 and its subclauses

INSAKATO has profound knowledge of the current state and development of all biosafety standards, being part of the expert committee of Dansk Standard (S-258).

Part 2: Animal welfare requirements
(less knowledge)

Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
(less knowledge; competence may be required within our network)

Part 4: Selection of tests for interactions with blood
(medium knowledge)

Part 5: Tests for in vitro cytotoxicity
(profound knowledge)

Part 6: Tests for local effects after implantation
(less knowledge; competence may though be included by further consultancy)

Part 7: Ethylene oxide sterilization residuals
(profound knowledge)

Part 9: Framework for identification and quantification of potential degradation products
(profound knowledge)

Part 10: Tests for skin sensitization
(profound knowledge)

Part 11: Tests for systemic toxicity
(less knowledge; competence may though be included by further consultancy)

Part 12: Sample preparation and reference materials
(profound knowledge)

Part 13: Identification and quantification of degradation products from polymeric medical devices
(profound knowledge)

Part 14: Identification and quantification of degradation products from ceramics

(profound knowledge)

Part 15: Identification and quantification of degradation products from metals and alloys
(profound knowledge)

Part 16: Toxicokinetic study design for degradation products and leachables
(less knowledge; competence may though be included by further consultancy)

Part 17: Establishment of allowable limits for leachable substances
(profound knowledge)

Part 18: Chemical characterization of materials
(profound knowledge)

Part 19: Physico-chemical, morphological and topographical characterization of materials
(profound knowledge)

Part 20: Principles and methods for immunotoxicology testing of medical devices
(less knowledge; competence may though be included by further consultancy)

Part 22: Guidance on nanomaterials
(profound knowledge)

Part 23: Tests for irritation
(profound knowledge)