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ISO 10993-4 2002 (amended 2006)
​Hemocompatibility

The Basic Study design requirements
Contains definitions of blood tests and interactions and a fairly long list of examples for each category of non-contact, indirect and direct contact externally communicating devices and implant devices.

Controls should be used and if a predicate is available should be used. 

A decision tree is presented on when to conduct blood compatibility evaluations.

2 tables are listed for implant devices and direct contacting externally communicating devices by type of device and then categories to be addressed.  All products must evaluate hemolysis.  Most implants in the vascular also have to evaluate thrombosis.  Most externally communicating devices must evaluate coagulation and platelets as well.

Platelets are assessed by evaluating platelet count and aggregation using an aggregometer. 

Coagulation is assessed using clinical test methods such as PTT (partial thromboplastin time)
https://www.nlm.nih.gov/medlineplus/ency/article/003653.htm  , PT (prothrombin time) https://www.nlm.nih.gov/medlineplus/ency/article/003652.htm  , TT (thrombin time)

Hematology is assessed by evaluating a white blood cell count and differential and hemolysis.

Immunology is assessed by evaluating multiple complement activation pathways.


ISO 10993-4 2006 amendment

Contains a list of updated definitions and updated tables that are easier to read specifying what tests are required for specific kinds of products.
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  • 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