1 Scope
This part of GB/T 16886 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
ISO 10993-2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements
ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
dose/dosage
amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area
3.2
dose-effect
relationship between the dosage and the magnitude of a defined biological effect either in an individual or in a population sample
3.3
dose-response
relationship of dosage to the spectrum of effects related to the exposure
Note: there are two types of dose-response relationships. The first type is the response of an individual to a range of doses. The second type is the distribution of responses of a population of individuals to a range of doses.
3.4
leachable substance
chemical removed from a device or material by the action of water or other liquids related to the use of the device
Note: examples of leachable substances are additives, sterilant residues, process residues, degradation products, solvents, plasticizers, lubricants, catalysts, stabilizers, anti-oxidants, colouring agents, fillers and monomers.
3.5
limit test
use of a single group treated at a suitable dosage of test sample in order to delineate the presence or absence of a toxic hazard
3.6
systemic toxicity
toxicity that is not limited to adverse effects at the site of contact between the body and the device
Note: systemic toxicity requires absorption and distribution of a toxicant from its entry point to a distant site at which deleterious effects are produced.
Foreword i
Introduction iv
1 Scope
2 Normative References
3 Terms and Definitions
4 General Considerations
5 Acute Systemic Toxicity
6 Repeated Exposure Systemic Toxicity (Subacute, Subchronic and Chronic Systemic Toxicity)
Annex A (Informative) Routes of Administration
Annex B (Informative) Dosage Volumes
Annex C (Informative) Common Clinical Signs and Observations
Annex D (Informative) Suggested Haematology, Clinical Chemistry and Urinalysis Measurements
Annex E (Informative) Suggested Organ List for Histopathological Evaluation
Annex F (Informative) Information on Material-mediated Pyrogens
Bibliography
1 Scope
This part of GB/T 16886 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
ISO 10993-2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements
ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
dose/dosage
amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area
3.2
dose-effect
relationship between the dosage and the magnitude of a defined biological effect either in an individual or in a population sample
3.3
dose-response
relationship of dosage to the spectrum of effects related to the exposure
Note: there are two types of dose-response relationships. The first type is the response of an individual to a range of doses. The second type is the distribution of responses of a population of individuals to a range of doses.
3.4
leachable substance
chemical removed from a device or material by the action of water or other liquids related to the use of the device
Note: examples of leachable substances are additives, sterilant residues, process residues, degradation products, solvents, plasticizers, lubricants, catalysts, stabilizers, anti-oxidants, colouring agents, fillers and monomers.
3.5
limit test
use of a single group treated at a suitable dosage of test sample in order to delineate the presence or absence of a toxic hazard
3.6
systemic toxicity
toxicity that is not limited to adverse effects at the site of contact between the body and the device
Note: systemic toxicity requires absorption and distribution of a toxicant from its entry point to a distant site at which deleterious effects are produced.
Contents of GB/T 16886.11-2011
Foreword i
Introduction iv
1 Scope
2 Normative References
3 Terms and Definitions
4 General Considerations
5 Acute Systemic Toxicity
6 Repeated Exposure Systemic Toxicity (Subacute, Subchronic and Chronic Systemic Toxicity)
Annex A (Informative) Routes of Administration
Annex B (Informative) Dosage Volumes
Annex C (Informative) Common Clinical Signs and Observations
Annex D (Informative) Suggested Haematology, Clinical Chemistry and Urinalysis Measurements
Annex E (Informative) Suggested Organ List for Histopathological Evaluation
Annex F (Informative) Information on Material-mediated Pyrogens
Bibliography
