GB/T 16886.20-2015 English PDF (GBT16886.20-2015)

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GB/T 16886.20-2015: Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.20-2015
Biological evaluation of medical devices - Part 20. Principles and methods for immunotoxicology testing of medical devices
ICS 11.100
C30
National Standards of People's Republic of China
Medical device biology evaluation
Part 20. Medical device immunotoxicology trials
Principles and methods
Part 20. Principlesandmethodsforimmunotoxicologytestingofmedicaldevices
(ISO /T S10993-20.2006, IDT)
Released on December 10,.2015
2017-01-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Administration issued
Foreword
GB/T 16886 "Biology Evaluation of Medical Devices" is divided into the following sections.
--- Part 1. Evaluation and testing in the risk management process;
--- Part 2. Animal welfare requirements;
--- Part 3. Genotoxicity, carcinogenicity and reproductive toxicity test;
--- Part 4. Test options for interaction with blood;
---Part 5. In vitro cytotoxicity test;
--- Part 6. Post-implantation local reaction test;
---Part 7. Ethylene oxide sterilization residue;
---Part 9. Qualitative and quantitative frameworks for potential degradation products;
--- Part 10. Stimulation and delayed type hypersensitivity test;
--- Part 11. Systemic toxicity test;
---Part 12. Sample preparation and reference samples;
--- Part 13. Qualitative and quantitative determination of polymer degradation products;
--- Part 14. Qualitative and quantitative determination of ceramic degradation products;
---Part 15. Qualitative and quantitative determination of metal and alloy degradation products;
---Part 16. Design of toxicokinetics of degradation products and solubles;
--- Part 17. The establishment of a limitable amount of leachables;
---Part 18. Chemical characterization of materials;
---Part 19. Physical chemistry, morphological and surface characterization of materials;
--- Part 20. Principles and methods for immunological toxicology testing of medical devices.
This part is the 20th part of GB/T 16886.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the translation method equivalent to ISO /T S10993-20.2006 "Medical Device Biology Evaluation Part 20. Medical Devices
Principles and Methods of Immunotoxicology Testing.
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (ISO 10993-1..1997, IDT)
GB/T 16886.2-2000 Biological evaluation of medical devices - Part 2. Requirements for animal protection (idt ISO 10993-2..1992)
GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6. Post-implantation partial response test (idtISO 10993-6.
1994)
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test
(ISO 10993-10.2002, IDT)
GB/T 16886.11-1997 Biological evaluation of medical devices - Part 11. Systemic toxicity test (idt ISO 10993-11.
1993)
YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.2007, IDT)
This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Hou Li, Yu Shaohua, Huang Jingchun, Liu Chenghu, Zeng Dongming, Zhang Jingping.
introduction
The main focus of international and European standards is to demonstrate the safety and compatibility of medical devices. Medical device guides in the past few years
The potential of the immune system to mutate has attracted more and more attention, so it is necessary to understand how the medical device is bad for the immune system.
Use the guide. Since there is currently no standardized trial, this document presents a framework for how to perform immunotoxicity assessments.
This document is.
--- outlining current cognitive status in the field of immunotoxicology, including information on immunotoxicity assessment methods and their predictive value;
--- Identify the problem and how it was handled in the past.
Clinical indications for immune variation induced by medical devices, mainly through extensive online medical literature analysis and retrieval systems
For review, the key areas of research are.
---Immunosuppressive;
---Immune stimulation;
--- Hypersensitivity reaction;
---Chronic inflammation;
---self-immune.
These keywords are related to the following materials.
---Plastic products and other polymers;
---metal;
---Ceramics, glass and composites;
---biomaterials.
Note. The potential interactions between materials and the immune system are shown in Table 1.
Medical device biology evaluation
Part 20. Medical device immunotoxicology trials
Principles and methods
1 Scope
This section of GB/T 16886 gives an overview of the immunotoxicology of the potential immunotoxicity of medical devices. This section also gives
A guide to methods for testing the immunotoxicity of different types of medical devices.
This section is based on several publications written by different groups of immunotoxicologists over the past few decades, with immunotoxicology as
An independent branch within the toxicology category is developing.
The current cognitive status of immunotoxicity is described in Appendix A, and Appendix B gives the immunotoxicity associated with medical devices to date.
An overview of the clinical experience of science.
Note. See reference [11].
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.2007, IDT)
ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua-
tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess)
ISO 10993-2 Medical Device Biology Evaluation Part 2. Animal welfare requirements (Biologicalevaluationofmedical
devices-Part 2.Animalwelfarerequirements)
ISO 10993-6 Biological evaluation of medical devices - Part 6. Post-implantation partial response test (Biologicalevaluationof
medicaldevices-Part 6.Testsforlocaleffectsafterimplantation)
ISO 10993-10 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test (Biologicalevalua-
tionofmedicaldevices-Part 10. Testsforirritationanddelayed-typehypersensitivity)
ISO 10993-11 Biological evaluation of medical devices - Part 11. Systemic toxicity test (Biologicalevaluationofmedical
devices-Part 11.Testsforsystemictoxicity)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Immunotoxicology
A study of the adverse health effects of foreign bodies directly or indirectly interacting with the immune system.
3.2
Medical device medicaldevice
The intended use of the manufacturer is for one or more of the following specific purposes, for humans, whether used alone or in combination,
Equipment, appliances, appliances, utensils, implants, in vitro reagent...