MD-Preclinical Safety Tests

MD-Preclinical Safety Tests

Last Updated on January 20, 2024 by BIOMEDRIC

Preclinical Safety Tests: Biological evaluation of medical devices (ISO 10993, the most widely used standard for assessing the biocompatibility of medical devices)

  • ISO 10993-1: Evaluation and testing within a risk management process
  • ISO 109932: Animal welfare requirements
  • ISO 109933: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
  • ISO 109934: Selection of tests for interactions with blood
  • ISO 109935: Tests for in vitro cytotoxicity
  • ISO 109936: Tests for local effects after implantation
  • ISO 109937: Ethylene oxide sterilization residuals
  • ISO 10993-9: Framework for identification and quantification of potential degradation products
  • ISO 1099310: Tests for irritation and skin sensitization
  • ISO 1099311: Tests for systemic toxicity
  • ISO 1099312: Sample preparation and reference materials
  • ISO 1099313: Identification and quantification of degradation products from polymeric medical devices
  • ISO 1099314: Identification and quantification of degradation products from ceramics
  • ISO 1099315: Identification and quantification of degradation products from metals and alloys
  • ISO 1099316: Toxicokinetic study design for degradation products and leachables
  • ISO 1099317: Establishment of allowable limits for leachable substances
  • ISO 1099318: Chemical characterization of materials
  • ISO 1099319: Physico-chemical, morphological and topographical characterization of materials
  • ISO 1099320: Principles and methods for immunotoxicology testing of medical devices

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