Biocompatibility Hub
  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search

ISO 10993-10 1995 Intracutaneous Reactivity

The Basic Study design requirements

 In 1995 it was in the main body.
 
There is an exemption statement that test articles are excluded when the pH is less than or equal to 2 or greater than or equal to 11.5 or if it is already known as an irritant in other tissues.
           
If there is to be preparation then the  test material preparation is according to an associated annex.
 
Three rabbits weighing 2 kg of either sex, from a single strain are specified.
 
The fur is to be shaved the day before the test.  The needle size used should be the smallest appropriate for viscosity of what is being injected.  There are five 0.2 ml injections of both polar and non-polar extracts and solvents.  Observations are made immediately after injection and at 24 hours, 48 hours, and 72 hours.
 
The sites are graded on 5 point scale ranging from no (0), very slight (1), well-defined (2), moderate (3), to severe (4) for both erythema and edema.  In calculationg the score only the 24, 48, and 72 hour scores are used for overall calculation.
 
How to calculate the score is rather ambiguous.  The end point is that the scoring is an irritation grade called the Primary Irritation Index ranging from negligible, slight, moderate and severe with numerical scores from 0.0 to 8.0 the maximum possible score for a single time point at any given site.  Therefore the calculation of the primary irritation index is the overall mean score for all sites of all animals.



Powered by Create your own unique website with customizable templates.
  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search