GB/T 16886.20-2015 Biological evaluation of medical devices - Part 20 : Principles and methods for immunotoxicology testing of medical devices
1 Scope
This part of GB/T 16886 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.
This part is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place.
The current state of knowledge with regard to immunotoxicity is described in Annex A. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in Annex B.
Note: See Bibliography [11].
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.
YY/T 0316-2008 Medical devices - Application of risk management to medical devices (ISO 14971:2007, IDT)
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 10993-6 Biological evaluation of medical devices - Part 6 : Tests for local effects after implantation
ISO 10993-10 Biological evaluation of medical devices - Part 10 : Tests for irritation and delayed-type hypersensitivity
ISO 10993-11 Biological evaluation of medical devices - Part 11 : Tests for systemic toxicity
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
immunotoxicology
study of the adverse health effects that result, directly or indirectly, from the interaction of xenobiotics with the immune system
3.2
medical device
any instrument, apparatus, appliance, machine, tool, implant, in vitro reagent or calibrator, software, material or other similar or related articles, whether used alone or in combination, intended by the manufacturer to be used on human beings solely or principally for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;
- investigation, replacement, modification or support of the anatomy or of a physiological process;
- support or sustain life;
- control of conception;
- disinfection of medical devices;
- provision of medical information by in vitro examination of samples taken from human body.
Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 Risk assessment and risk management
5 Identification of hazards
6 Methods of assessment of immunotoxicity
7 Extrapolation of data provided by pre-clinical assays
Annex A (informative) Current state of knowledge
Annex B (informative) Clinical experience with medical devices
Annex C (informative) Flow chart for immunotoxicity testing
Bibliography
