GB/T 16886.2-2011 PDF in English
GB/T 16886.2-2011 (GB/T16886.2-2011, GBT 16886.2-2011, GBT16886.2-2011)
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Biological evaluation of medical devices -- Part 2: Animal welfare requirements
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GB/T 16886.2-2011: PDF in English (GBT 16886.2-2011) 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 the trial, and
When the nature is more serious, pre-established, special standards or measures are taken to reduce and terminate the animals caused by animal testing.
Pain, pain or discomfort.
3.7
Procedural training proceduraltraining
Pre-training and adaptation of animals during animal testing minimizes animal stress during animal testing.
3.8
Test protocol protocol
The rationale, principles, and test methods (including scientific and humane endpoints) for animal testing are documented for animal testing.
3.9
Breeding animal purpose-bredanimal
Any farm animal intended for animal testing or for other experimental or scientific purposes.
3.10
Reduce reduction
Reduce the number of animals used in animal testing to the minimum required to meet the required scientific requirements.
3.11
Optimize refinement
Taken to maintain the welfare of experimental animals by minimizing pain, pain, discomfort or sustained damage to the animals used
All measures.
3.12
Alternative replacement
Any scientifically validated, reasonable and practical test that completely or partially replaces a living vertebrate without causing pain or pain to the animal
method.
3.13
Experimental animal testanimal
Animals for in vivo animal testing or for providing tissue for in vivo or in vitro testing.
3.14
Confirmation of validation
A normative procedure for establishing the reliability and suitability of test methods for a specific purpose.
4 requirements
4.1 General
This part of ISO 10993 gives the consideration, design or use of animal tests for the biological evaluation of materials for medical devices.
basic requirements.
This section is used to protect the welfare of animals used in the biological evaluation of materials for medical devices and to help ensure test results and
The scientific validity of the risk assessment should be carried out afterwards.
The focus of this section is on the evaluation of the biological properties of medical device materials by experts and the application of the principles of humane experimental techniques to animal testing.
The design and implementation of the test needs to confirm that animal welfare has been properly considered.
This section requires an animal test to demonstrate that the animal's pain, pain, or sustained damage during animal testing is minimized.
degree.
This section lists the basic requirements for maintaining animal welfare. The following measures are taken to consider the animal's pain and when considering or conducting animal tests.
The pain is reduced to a minimum.
a) Establish a framework that reflects the legal aspects of the corresponding ethics and competence, and the use of animals for experimental or other scientific purposes.
Consideration
b) Minimize by appropriate use of literature search, data sharing, validation alternatives, appropriate testing strategies and research designs
The number of animals tested;
c) require the appropriate reduction and optimization methods to be used to evaluate the pain and pain of experimental animals in the biocompatibility of medical device materials.
Bitter or sustained damage to a minimum;
d) Promote animal feeding and management in accordance with high standards to maintain the welfare of the animals used and the scientific validity of the test data
And reproducibility.
For the above purposes, the design and implementation of animal biocompatibility animal testing for medical device materials should be combined with corresponding substitution, reduction and superiority.
Strategies for animal testing.
Animal testing conducted without research and without this information and without implementing these measures in accordance with the recommendations in this section
The test does not meet the basic requirements of this section.
Note. These principles and basic requirements in this section may also be related to animal testing of medical device materials and medical devices in other situations.
4.2 Rationality of animal testing
In cases where appropriate regulations are required to ensure human safety, animal testing may be appropriate for medical device materials.
Biological characterization is acceptable.
In view of the objectives of the ISO 10993 standard, animal testing is considered reasonable only in the following cases.
---Test data is not available in other ways, but is not mandatory for the proper use of test materials used in the scope of the ISO 10993 standard.
Less;
--- When there is no scientifically validated, reasonable and practical test method that does not involve the use of living animals;
---Identified and implemented appropriate reduction and optimization strategies, including obtaining applicable test data from manufacturers and suppliers and inspections
Literature on toxicity and biocompatibility data.
In order to avoid unnecessary repetitive testing, a test should be conducted before conducting an animal test to evaluate the biocompatibility of materials used in medical devices.
Review and document the information on material utilization and performance. Reasonable measures should be taken to enable data to be shared.
Animal testing is considered reasonable only in the following circumstances.
a) The test indicates relevance and reliability to the purpose of the test;
b) Test data is essential for the proper characterization and evaluation of test materials used in medical devices in the ISO 10993 standard;
c) there is no scientifically effective method of not using live animals;
d) Identify and implement other appropriate strategies to minimize the pain and suffering of the animal.
4.3 Personnel ability
Animal testing should be designed, implemented and interpreted by a designated and qualified person.
Animal testing should be designed and implemented by personnel with expertise in veterinary medicine, laboratory zoology and animal husbandry and management.
In order to meet animal testing requirements, specific requirements for internships, qualifications and training (including professional continuing education) should be documented.
Note. Although no specific requirements are given in this section, it is important to protect and respect the animals used in animal testing, that is, to adopt appropriate “civilizations” for animals.
Feeding."
4.4 Animal test plan and implementation
4.4.1 General
The selection and design of animal experiments should be consistent with the specific scientific objectives of the study, and the pain, pain and persistence that may be caused to the experimental animals.
Continued damage is minimized.
As described in 4.2, only the required information is essential for characterizing the test material, and the test data is not available in other ways.
Animals should be carried out without a scientifically validated, appropriate, reasonable and practical test method that does not involve the use of living animals.
test.
Prior to conducting animal testing, the main investigator and/or inspection is conducted with appropriate alternative, reduction and optimization strategies in mind.
The document should demonstrate that there is no need to adopt alternative, reduction and optimization strategies to reduce the animal welfare cost of the study.
Note. In some pre-test situations, an optimized test design may be required prior to designing and conducting an arbitration test.
The provisions of the ISO 10993 standard require that the animal be tested for the species range, stage of progress or number of animals to be selected.
Protect the effectiveness of the test and minimize the pain, pain and sustained damage of the animals used. The selection principle should be documented.
4.4.2 Animal reuse
In order to avoid inappropriately accumulating welfare costs for the individual animals used, it should be weighed against the requirement to reduce the number of animals.
In general, animals should not be used for more than one test.
The pain and pain experienced by an animal during an animal test or previous use may affect the results of the retest.
This should not be repeated for animals.
Reuse of animals should be scientifically appropriate and should not result in excessive cumulative welfare costs for individual animals.
Reuse of animals should be documented, giving a summary description of the previous use and determining that it has been considered and complies with the
Claim.
4.5 Test strategy - the sequence of in vitro and in vivo tests
Where appropriate, the test strategy should be carried out in a gradient or grading manner to determine the number of animal tests to be performed and to carry out the animals.
The pain or pain caused by the test is minimized. Especially in conducting appropriate, scientifically recognized and reasonably practical in vitro tests and
Unnecessary animal testing should not be performed prior to the evaluation of the results.
Such as existing data (eg retrieval of data from literature and/or databases, previous screening tests, approved in vitro tests, animal test results)
Or any other relevant relevant evidence) that provides adequate and appropriate risk assessment information on the biocompatibility of the test material,
Animal testing should be conducted.
The test strategy description should be documented.
4.6 Animal Feeding and Management
4.6.1 General
Breeding animals should be used where possible, and non-breeding animals are required for special reasons.
If no breeding animals are used, the rationale for the use of the animal and the source of the animal should be documented.
High standards of feeding and management improve the welfare of the animals used and promote the scientific validity of animal testing. The most animal breeding and management
Low requirements should be confirmed in accordance with the relevant national or international standards for animal feeding management and animal management guidelines.
Relevant guidance or requirements should be consulted for the evidence of conformity provided (or details that do not comply with the relevant guidelines or requirements, including
The possible effects of animal welfare and the validity of the data obtained should be documented, demonstrated and documented.
Animal management systems that do not provide the best benefits for experimental animals may affect the scientific validity of the test or the results of the test.
The nature or interpretation has an undue influence and should be documented.
If it is not for veterinary, management, animal welfare or scientific reasons, the group animal species need to be raised separately, and should be harmonious
Set up in pairs or groups.
If the genus of gregarious animals cannot be raised in pairs or in groups, the time of feeding and feeding alone involves veterinary, management, animal welfare or science.
The requirements of the aspects should be documented. The impact on scientific outcomes should be evaluated and documented.
Habits and practices should not be considered as legitimate reasons.
4.6.2 Animal fixation
In animal experiments, if animal activities need to be restricted, the degree and nature of fixation to animals should be as far as possible for scientific purposes.
Light, time is as short as possible. This should be documented.
4.6.3 Surgical procedures
All surgical procedures should be performed under animal anesthesia. The principle and procedure of surgery should minimize the incidence of surgical sepsis.
The incidence of surgical sepsis should be documented.
Pre-operative, intra-operative, and post-operative animal care regulations, including the reliable and effective use of analgesics, should be established in accordance with modern veterinary clinical practice.
The implementation plan should be documented.
4.7 Humane end point
4.7.1 General
The humane end point should meet several possible conditions and should not only contain dead animals or animals that indicate signs of serious welfare problems.
At least once a day, the welfare and conditions of all experimental animals are checked by a professional, and the findings of the inspection should be documented.
If significant signs of poor animal welfare are found, observations of the animals should be strengthened.
Appropriate supportive, symptomatic, and targeted treatment of experimental animals should be performed to minimize animal blessings that occur during animal testing.
The issue of benefit should be negotiated with a qualified veterinarian or directed by a veterinarian. The provisions for disposal and/or the reasons for termination should be documented.
Animals that suffer from unbearable severe pain or pain should be promptly executed in a humane manner.
Animal deaths (except for humane deaths) do not need to meet the requirements of the ISO 10993 standard and should not be used to set animal deaths as medical
The necessary endpoint for animal material biocompatibility animal testing.
Documentation supporting the details of the animals that died during the animal test should be retained and the test procedure is in accordance with ISO 10993. in
In some cases, this animal death event indicates that all relevant optimization strategies identified and implemented failed.
4.7.2 Humanitarian execution
The humane method of death at the end of the animal test should allow the animal to quickly lose consciousness without pain or suffering.
death.
The method of humane execution that is selected and implemented should be specified in the document and explain the reasons, and the statement meets the requirements of this part.
Appropriate equipment should be available for proper maintenance. The person responsible for this work should have been properly trained and technically competent.
4.8 Research documents
The research document should describe how to determine and implement the animal test, and if the statement meets the requirements of this section, the relevant body part should be submitted.
The design of the animal test should be standardized and documented, and in appropriate and appropriate circumstances, the animal test should be designed in detail in the study protocol.
And include the following information.
a) the requirements of the ISO 10993 specific standards and the scientific objectives to be achieved by the test;
b) known information about the existing information and materials of the composition in terms of research and use or intended use of the material;
c) descriptions and reasons for the animals used (see 4.2);
d) The research documents should include.
1) Test strategy (see 4.5);
2) Scientific reasons for the species, development, strain and quantity of the animal used, including the number of animal groups and the positive and negative control groups
Necessity (see 4.2 and 4.4.1);
3) the source and health status of the animals used; specific reasons should be given for non-breeding animals (see 4.6.1);
4) Details of the animal feeding and management system (see 4.6.1);
5) A detailed description of the procedures used and the information collected (see 4.4.1, 4.4.2, 4.6.2 and 4.6.3);
6) Observe the schedule and the humane endpoints used, as well as key personnel operational details (see 4.7);
7) methods and reasons for the humane methods of execution chosen (see 4.7.2);
8) Detailed information on the analytical and statistical methods used.
4.9 Validity of test results and mutual recognition of data
Mutual recognition of test data effectively reduces the need for animal testing and facilitates ethical normative decisions. Where possible, the test side
The law should be based on an internationally recognized programme and should be tested under an accredited quality standard system, for example in accordance with good laboratory quality management.
Normative guidelines.
Appendix A
(informative appendix)
Description of this section
A.1 General
Ideally, the basic requirements of ISO 10993 are met without animal testing.
In the event that the development, validation, and coordination of appropriate alternative test methods are inconclusive, the rules of this section will be required.
The pain and pain caused by animal testing is minimized.
A.2 Humane animal feeding and use principles
The planned animal testing should be carried out in an appropriate civilized manner and in accordance with the principle of the best combination of science and animal welfare.
It is advisable to formulate specific and comprehensive regulations to minimize the pain and suffering of animals that cannot be avoided during animal testing.
Animal welfare costs associated with animal production, rearing and use in animal testing are eliminated.
In many cases, expert advice is needed to determine the most complete and scientifically valid test strategy to weigh different considerations. for
Minimize animal welfare costs and consider reducing and optimizing strategies at the same time, rather than considering them separately.
Sometimes it is necessary to consider the choice of test methods and test protocols within the scope of a scientifically acceptable strategy, and in some cases, the best optimization
This may be done by using a larger number of animals but without more humane endpoints or by using fewer high-sensitivity species. In solution
When it comes to the reduction and optimization measures proposed in the ISO 10993 standard, it is necessary to confirm and weigh the potential based on reliable information and expert opinions.
Disagreement. The final decision can be based on expert opinion, but it is important to minimize the animal while ensuring scientific validity.
The cost of welfare.
For this reason, the program considerations, factor trade-offs and evaluation verification should be disclosed when the suitability of the scheme adopted is verified.
Transparent. When conducting professional evaluation and verification, the researcher should be prepared to confirm what is done, what is done and how to do it in the supporting documents.
reason.
A.3 replacement
Any test method using an inanimate substitute to replace a living vertebrate in an alternative is generally acceptable. In medical
There are currently no approved alternative test methods for many aspects of material biology evaluation of devices.
A.4 reduction
The definition of reduction is to reduce the number of animals used to a minimum required for a defined scientific purpose, including the exclusion of unnecessary
Test strategy (appropriate animal test selection and data sharing to eliminate the need for repeated trials). If practical, two tests should be considered
Strategy (sequence of trials and evaluations) and design of specific trials.
The test strategy should be in a gradient or hierarchical manner. In vitro screening tests can sometimes be used to identify materials that are not suitable for use in medical devices.
This form, and this in vitro screening test can avoid the need for confirmatory animal testing. In other cases, a biological
The evaluation of energy can be predicted by other aspects (such as strong skin irritant or eye irritant), or the pretest results can be avoided.
Use of other animals (such as a rabbit with obvious signs of eye irritation can fully characterize the test material).
Different from the past, it is possible to analy......
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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