Biological Effect | USP General Chapter |
Cytotoxicity | Biological Reactivity Tests, In Vitro 87* |
Sensitization | [to come] |
Irritation or intracutaneous reactivity | Biological Reactivity Tests, In Vivo 88 |
Systemic toxicity (acute toxicity) | Biological Reactivity Tests, In Vivo 88 |
Subchronic toxicity (subacute toxicity) | [to come] |
Genotoxicity | [to come] |
Implantation | Biological Reactivity Tests, In Vivo 88 |
Hemocompatibility | Under development in the USP monograph Sterile Single-Use Plastic Large-Volume Containers for Human Blood and Blood Components |
Chronic toxicity | [to come] |
Carcinogenicity | [to come] |
Reproductive or developmental toxicity | [to come] |
Biodegradation | [to come] |
*
Additional general chapters referring to this biological effect include Transfusion and Infusion Assemblies and Similar Medical Devices 161, Elastomeric Closures for Injections 381, and ContainersPlastics 661.
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Additional general chapters referring to this biological effect include Injections 1, Transfusion and Infusion Assemblies and Similar Medical Devices 161, Elastomeric Closures for Injections 381, and ContainersPlastics 661.
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Device Category | Device Subcategory | Nature or Extent of Contact | Some Examples |
Skin | Devices that contact intact skin surfaces only | Electrodes, external prostheses, fixation tapes, compression bandages, and monitors of various types | |
Surface Devices | Mucosal Membrane | Devices communicating with intact mucosal membranes |
Contact lenses, urinary catheters, intravaginal and intraintestinal devices (stomach tubes, sigmoidoscopes, colonoscopes, gas troscopes), endotracheal tubes, bronchoscopes, dental prostheses, orthodontic devices, and intrauterine devices |
Breached or Compromised Surfaces | Devices that contact breached or otherwise compromised body surfaces | Ulcer, burn, and granulation tissue dressings or healing devices and occlusive patches | |
Blood Path, Indirect | Devices that contact the blood path at one point and serve as a conduit for entry into the vascular system | Solution administration sets, extension sets, transfer sets, and blood administration sets | |
External Communicating Devices |
Tissue, Bone, or Dentin Communicating | Devices and materials communicating with tissue, bone, or pulp and dentin system | Laparoscopes, arthroscopes, draining systems, dental cements, dental filling materials, and skin staples |
Circulating blood | Devices that contact circulating blood | Intravascular catheters, temporary pacemaker electrodes, oxygenators, extracorporeal oxygenator tubing and accessories, dialyzers, dialysis tubing and accessories, hemoadsorbents, and immunoadsorbents | |
Implant Devices | Tissue or Bone | Devices principally contacting bone or principally contacting tissue and tissue fluid | Examples of the former are orthopedic pins, plates, replacement joints, bone prostheses, cements, and intraosseous devices; examples of the latter are pacemakers, drug supply devices, neuromuscular sensors and simulators, replacement tendons, breast implants, artificial larynxes, subperiosteal implants, and ligation clips |
Blood | Devices principally contacting blood | Pacemaker electrodes, artificial arteriovenous fistulae, heart valves, vascular grafts, internal drug delivery catheters, and ventricular-assist devices |
Device Categories | Biological Effectb | |||||||||||||
Body Contact | Contact Durationa | Cytotoxicity | Sensitization | Irritation or Intracutaneous Reactivity | Systemic Toxicity (Acute) | Subchronic Toxicity (Subacute) | Genotoxicity | Implantation | Hemocompatability | Chronic Toxicity | Carcinogenicity | Reproductive or Development Toxicity | Biodegra- dation |
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A | X | X | X | | | | | | | | | | ||
Skin | B | X | X | X | | | | | | | | | | |
C | X | X | X | | | | | | | | | | ||
Surface Devices |
Mucosal Membrane |
A | X | X | X | | | | | | | | | |
B | X | X | X | O | O | | O | | | | | | ||
C | X | X | X | O | X | X | O | | O | | | | ||
Breached or Compromised Surfaces |
A | X | X | X | O | | | | | | | | | |
B | X | X | X | O | O | | O | | | | | | ||
C | X | X | X | O | X | X | O | | O | | | | ||
a
Legend Alimited (less than 24 hours); Bprolonged (24 hours to 30 days); Cpermanent (more than 30 days).
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||||||||||||||
b
Legend XISO evaluation tests for consideration; Oadditional tests that may be applicable.
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||||||||||||||
*
Adapted from the FDA's Blue Book Memorandum #G95-1 (Table 1. Initial Evaluation Tests for Consideration and Table 2. Supplementary Evaluation Tests for Consideration).
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Device Categories | Biological Effectb | |||||||||||||
Body Contact | Contact Durationa | Cytotoxicity | Sensitization | Irritation or Intracutaneous Reactivity | Systemic Toxicity (Acute) | Subchronic Toxicity (Subacute) | Genotoxicity | Implantation | Hemocompatability | Chronic Toxicity | Carcinogenicity | Reproductive or Development Toxicity | Biodegra- dation |
|
Blood Path, Indirect |
A | X | X | X | X | | | | X | | | | | |
B | X | X | X | X | O | | | X | | | | | ||
C | X | X | O | X | X | X | O | X | X | X | | | ||
External Communicating Devices |
Tissue, Bone, or Dentin Communi- cating |
A | X | X | X | O | | | | | | | | |
B | X | X | O | O | O | X | X | | | | | | ||
C | X | X | O | O | O | X | X | | X | X | | | ||
Circulating Blood |
A | X | X | X | X | | O | | X | | | | | |
B | X | X | X | X | O | X | O | X | | | | | ||
C | X | X | X | X | X | X | O | X | X | X | | | ||
a
Legend Alimited (less than 24 hours); Bprolonged (24 hours to 30 days); Cpermanent (more than 30 days).
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b
Legend XISO evaluation tests for consideration; Oadditional tests that may be applicable.
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*
Adapted from the FDA's Blue Book Memorandum #G95-1 (Table 1. Initial Evaluation Tests for Consideration and Table 2. Supplementary Evaluation Tests for Consideration).
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Device Categories | Biological Effectb | |||||||||||||
Body Contact | Contact Durationa | Cytotoxicity | Sensitization | Irritation or Intracutaneous Reactivity | Systemic Toxicity (Acute) | Subchronic Toxicity (Subacute) | Genotoxicity | Implantation | Hemocompatibility | Chronic Toxicity | Carcinogenicity | Reproductive or Development Toxicity | Biodegra- dation |
|
A | X | X | X | O | | | | | | | | | ||
Tissue or Bone |
B | X | X | O | O | O | X | X | | | | | | |
Implant Devices |
C | X | X | O | O | O | X | X | | X | X | | | |
A | X | X | X | X | | | X | X | | | | | ||
Blood | B | X | X | X | X | O | X | X | X | | | | | |
C | X | X | X | X | X | X | X | X | X | X | | | ||
a
Legend Alimited (less than 24 hours); Bprolonged (24 hours to 30 days); Cpermanent (more than 30 days).
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||||||||||||||
b
Legend XISO evaluation tests for consideration; Oadditional tests that may be applicable.
|
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*
Adapted from the FDA's Blue Book Memorandum #G95-1 (Table 1. Initial Evaluation Tests for Consideration and Table 2. Supplementary Evaluation Tests for Consideration).
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Topic/Question | Contact | Expert Committee |
General Chapter | Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(GTMDB05) General Toxicology and Medical Device Biocompatibility |