GB/T 16886.2-2011 English PDF (GBT16886.2-2011)

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GB/T 16886.2-2011: Biological evaluation of medical devices -- Part 2: Animal welfare requirements
GB/T 16886.2-2011
Biological evaluation of medical devices.Part 2. Animal welfare requirements
ICS 11.040.01
C30
National Standards of People's Republic of China
Replace GB/T 16886.2-2000
Medical device biology evaluation
Part 2. Animal welfare requirements
Part 2.Animalwelfarerequirements
(ISO 10993-2.2006, IDT)
Published on.2011-12-30
2012-05-01 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 "Biological Evaluation of Medical Devices" consists of the following components.
--- 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. Method for establishing limits for solubles;
---Part 18. Chemical characterization of materials;
---Part 19. Physical chemistry, morphological and surface characterization of materials;
--- Part 20. Principles and methods for immunological toxicity testing of medical devices.
This part is the second part of GB/T 16886.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 16886.2-2000 "Biological Evaluation of Medical Devices Part 2. Animal Protection Requirements", and GB/T 16886.2-
Compared with.2000, the main technical changes are as follows.
--- Modified the standard name;
--- Modified and added "3 terms and definitions";
--- Completely revised the "4 requirements" and added chapters such as "General Provisions" and "Humanitarian Endpoints";
--- Cancel the "5 suggestions";
--- Added Appendix A to prepare a description for this section;
--- Added Appendix B, and proposed other recommendations for replacing, reducing, and optimizing animal testing, including the original "5 recommendations."
This section uses the translation method equivalent to ISO 10993-2.2006 "Medical Device Biology Evaluation Part 2. Animal Welfare Requirements."
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing (ISO 10993-1.2009, 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. Yu Shaohua, Wang Wei, Huang Jingchun, Wang Kelei, Liu Chenghu.
This section was first released in December.2000.
introduction
The purpose of the GB/T 16886 standard is to protect humans during the use of medical devices.
This part of GB/T 16886 supports the GB/T 16886 standard, making maximum use of scientific and reasonable non-animal tests, and
Ensuring the biological performance of materials used to evaluate medical devices is tested in accordance with recognized ethical and scientific principles.
The application of this humane experimental technique includes high standards of animal feeding and management, helping to ensure the scientific validity of safety testing.
And improve the welfare of the animals used.
Medical device biology evaluation
Part 2. Animal welfare requirements
1 Scope
This part of GB/T 16886 is applicable to commissioning, designing and conducting tests or evaluating animal test data for materials used in medical devices or
The process of evaluating the biocompatibility of the device. This section sets out the most basic requirements to ensure evaluation through the corresponding regulations
Medical Device Materials Biocompatibility Animals are used for animal welfare and documented.
This section also provides recommendations and guidelines to further reduce the overall number of animals and optimize test methods to reduce or eliminate animals.
Pain or pain, as well as other scientifically effective methods that do not require animal testing to replace animal testing.
This section applies to live vertebrate tests other than humans, which are used to determine the biocompatibility of materials or medical devices.
This section does not apply to tests performed on invertebrates and other less differentiated animals, nor does it apply to implementation.
Tests performed on human tissues and organs isolated from human vertebrate (except animal species, source, health status, feeding and management regulations)
Fixed aspects).
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.
ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua-
tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess)
3 Terms and definitions
The following terms and definitions defined by ISO 10993-1 apply to this document.
3.1
Alternative method alternativemethod
Any test method that can replace animal testing, reduce the number of animals, or improve the operating procedures.
3.2
Animal animal
All living non-human vertebrates, excluding animals that are not fully developed in the first half of pregnancy.
3.3
Animal test animaltest
Any application to animals for scientific purposes.
Note 1. Animal test definitions do not include approved veterinary practices, approved animal and fauna management and conservation practices for animal and fauna welfare
And the method of marking animals with the least pain method and humane execution.
Note 2. Preventing pain, pain or sustained damage by effectively applying anesthesia or analgesics and other methods of eliminating pain (such as brain resection)
The term animal terminology. Anesthesia, analgesics or other methods of eliminating pain can be considered as an integral part of animal testing.
3.4
Competent authority
Designated or approved by national government departments to supervise, manage or regulate animal testing within the scope of this section or for breeding
Department of animal reproduction and supply agencies.
3.5
Humane way to death eutanasia
Animals are humanely sacrificed in a manner that minimizes the suffering of the animal's body and spirit.
3.6
Humane endpoints
When the trial has met or failed to meet the research objectives, or the animal welfare issues are more important than the research, the expected benefits, the purpose of th...