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YY/T 1754 Preclinical animal study of medical devices consists of the following parts:
——Part 1: General considerations;
——Part 2: Model of skin defect in induced diabetic rats;
This is part 1 of YY/T 1754.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of the National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China (SAC/TC 248).
Drafting organizations of this part: Shandong Product Quality Inspection Center of Medical Equipment, and Center for Medical Device Evaluation, NMPA.
Chief drafting personnel of this part: Liu Chenghu, Cheng Maobo, Li Chunling, Liu Wenbo, Shi Xinli, Gao Ranran, and Wei Zhenxi.
Preclinical animal study of medical devices—
Part 1: General considerations
1 Scope
This part of YY/T 1754 specifies general considerations of preclinical animal study of medical devices.
This part is applicable to the design and data collection of animal tests of preclinical medical devices.
Note: This part does not replace the technical documents related to biological evaluation of medical devices such as GB/T 16886 series standards. If the biocompatibility of medical devices is evaluated by animal tests, please refer to GB/T 16886 series standards and other technical documents related to biological evaluation.
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 (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
GB/T 16886.2 Biological evaluation of medical devices—Part 2: Animal welfare requirements
3 Terms and definitions
For the purpose of this document, the terms and definitions given in GB/T 16886.1 and GB/T 16886.2 apply.
4 General
4.1 The purpose of preclinical animal study of medical devices is to provide evidence of the safety of medical devices, including safety-related performance and manipulation, and to evaluate the effectiveness and feasibility of the medical devices. Animal models that have been scientifically demonstrated should be selected. For some specific types of medical devices which may not have well-established or acceptable animal models, alternative animal models can be used and properly demonstrated.
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4.2 Animal study usually provides preliminary evidence for the effects of medical devices on biological systems, and also evaluates the impact of biological systems on medical devices, such as corrosion and structural deformation of medical devices.
4.3 The design of animal study protocol should consider the adequacy of the control, the timing and routes of intervention, and methods of reducing bias, such as blind method, randomized method, use of control, sample size based on expected biological response, reporting of lost data and statistical considerations.
4.4 The preclinical animal study of medical devices shall be conducted under the effective laboratory quality management system.
5 Study planning and protocol
5.1 Preclinical animal study of medical devices should be planned and guided by personnel with appropriate qualifications or rich experience.
5.2 Risks related to medical devices should be identified through preliminary laboratory study and other relevant information, such as scientific reports and literature review, including those identified according to GB/T 16886.1. The study is designed to research all the identified risks related to medical devices.
5.3 Animal study shall be guided by a preliminary study protocol which shall be approved by the client and on which name and date shall be signed by the person in charge of the test. Any change or revision of the final approved protocol and the reasons for the change or revision must be documented, dated and signed by the person in charge of the test. The number of animals and test groups should be designed on the basis of the preliminary small-scale tests and laboratory studies. The minimum number of test animals should be used. At the same time, suitable test control, potential interference factors and the best observation period should be considered.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Study planning and protocol
6 Elements of animal study
7 Personnel
8 Institution
9 Study methods and implementation
10 Records and reports
