1. Which products can apply for priority inspection?

 

Under the premise that the following products are not reduced and the procedures are not reduced, the inspection can be given priority:

(1) The innovative medical device products that are confirmed by the State Drug Administration or meet the requirements of the Jiangsu Provincial Drug Administration;

(2) New products I have not accepted;

(3) Medical device products involved in the national and provincial science and technology projects I participated in;

(4) Ultrasound surgical equipment consistent with the research direction with our key laboratory.

 

2. GB9706.1-2020 Implementation Date: 2023-05-01, can the registered inspection be tested in accordance with the new standard?

 

It is not yet available, because the new standard's inspection qualification has not been obtained.

 

3. In the new version of GB9706.1-2020, the protection of ultra-temperature protection is mentioned that if the temperature of the winding or other methods is mentioned, the temperature limit should be reduced by 10 ° C. Will the increase in this explanation affect the pass rate of product testing?

 

The thermocouple method tests the temperature of the winding surface, not the temperature inside the winding. The surface temperature will be about 10 ° C lower than the internal temperature. Therefore, the temperature limit of 10 ° C will not affect the pass rate of the product test.

 

4. How to evaluate and control the change of key meta devices?

 

The change of key meta devices mainly depends on whether it causes changes in electrical structures, such as replacing the power cord and the supplier of replacing the fuse. These will not cause changes in the electrical structure. If it involves changes in electrical structure, such as replacing transformers and switching power, these are directly related to the protection of electrical isolation. At this time, it is recommended to do a change test.

 

5. Does the transformer inside the power supply during the detection need an additional provision?

 

unnecessary. In the inspection notice, the additional transformer provides an additional transformer for testing is based on the GB9706.1 standard 57.9 network power transformer. The transformer here is specially refers to the network power transformer, and the transformer of the secondary circuit or the internal transformer inside the switching power supply does not belong to the network power isolation transformer, so it does not need to be provided during detection.

 

6. Is the microwave attachment electromagnetic compatibility detection?

 

Can't. In GB 9706.6, each attachment must be tested.

 

7. How is Class A and B in the electromagnetic compatible launch test defined?

 

According to the actual scope of the product, the products used in hospitals or professional medical places are categories A, and products used in family or non -professional medical places are Class B. The test limits of the two types of products are different. Class B is high, and the requirements of Class A are high, and the requirements are more stringent.

 

8. Does the product of electrical safety rectification affect the results of electromagnetic compatibility inspection? If there is, which rectification measures will affect?

 

Electrical safety rectification may affect the results of electromagnetic compatibility tests: ground changes, cable changes, replacement of key components, shell changes, key components change, replacement of display, etc.

 

9. Can the in vitro diagnostic reagent detection, can I apply for testing?

 

If the reagent is a closed reagent, the instrument and equipment that the enterprise is developed by itself is required to test it, and the equipment is large and is not conducive to handling.

 

10. During the detection of in vitro diagnostic reagents, do the supporting testing instruments provided by the enterprise must have a medical device registration certificate?

 

Not necessarily, in addition to medical device registration certificates, it can also provide metering calibration certificates of the instrument or the type inspection report of the instrument.

 

11. How many samples should be prepared when the in vitro diagnostic reagent is sampled or sampled for inspection?

 

Samples should be prepared to meet the requirements of a three -fold inspection volume.

 

12. How to choose the accuracy of in vitro diagnostic reagents?

 

There are national standard substances to choose national standard substances, and secondly choose international standard substances. In the case of neither of them, you can choose to use the internal reference of the enterprise.

 

13. How to choose the accuracy method of the in vitro diagnostic kit?

 

It is generally recommended to adopt a relatively deviation method. In the absence of standard products, the standards of some industries require the method of recovery; the method of comparison can also be used.

 

14. How to evaluate the correctness of the calibration analyzer?

 

If there is a standard substance, it should be evaluated with standard substances. If there is no standard substance, you can use the internal reference material of the enterprise to evaluate.

 

15. How to detect the stability of the quality control period of in vitro diagnostic reagents?

 

According to YY/T 1652-2019 "GEMID Technology Requirements for Endogenic Diagnostic Reagents\\ Statistical processing; b) The detection of expected results at the end of the validity period. Usually select method A), that is, the enterprise provides stable research data.

 

16. How to choose linear samples in vitro diagnostic reagents?

 

In addition to special regulations, clinical samples are recommended.

 

17. Do I need to explain the test preparation conditions in detail? For example: the proportion of soaking, the temperature, the time of the lifting, etc.

 

When the limited unit of the product bacterial toxin is EU/ML, the company needs to explain the test preparation conditions. Other limited units such as: EU/set, EU/piece, EU/MG, etc., do not need to explain the test preparation conditions.

 

18. When there are many cytotoxic test methods, which method does the company choose?

 

Based on GB/T 16886.5-2017 "Part 5 of Medical Devices Biology Evaluation: Ectopic Cyanotoxic Test\\ The qualitative evaluation uses the microscope to check the cells, and observes records of cell form, cell dissolution, and cell membrane integrity; quantitative evaluation is quantitative testing of parameters such as cell quantity and total amount of protein. The MTT method used for quantitative evaluation (GB/T16886.5-2017 Appendix C method) was tested.

 

19. When the biological evaluation product is for multi -components, what are the instructions for enterprises?

 

Enterprises need to clearly test which components are sampled; secondly, it is clear whether each component is a separate test or a multi -component preparation into a mixed test. If it is a mixed test, the proportion of each component is also required.

 

20. In biological evaluation, the tests such as implantation need to be selected as a listed product as a negative control. It is difficult to buy by enterprises and the price is expensive. Can it be replaced by other materials?

 

Aluminum and stainless steel. Enterprises can combine the characteristics of inspection products to select a material that is similar to its product characteristics to make the test samples as a negative control.

 

21. The basis for sterile testing is written GB/T 14233.2-2005 or Chinese Pharmacopoeia, or should both be written?

 

If there are clear stipulations in the national standard line, the test method is selected in accordance with the prescribed regulations; if there is no mandatory regulations, the enterprise can choose the basis for the detection of the product according to the actual situation of the product.

 

22. Product Sterile method Application Verification results have no bacteriostatic results. Considering the economic benefits of consumables. Can the amount of medium during sterile inspection be reduced?

 

Can't. According to the regulations of the Pharmacopoeia, the testing methods and inspection conditions used in the sterile inspection of the test should be the same as the method recognized by the method.

 

23. What are the instructions for enterprises to provide in the surgical form according to YY/T 0506.5-2009, YY/T 0506-2009 when the dry microbial penetration test and the hydroelectronomy microbial penetration test?

 

Enterprises should clarify the key areas and non -critical areas of the product. The key areas should meet the performance requirements of the damp -blocked microbial penetration, and non -critical areas should meet the performance requirements of the dried microbial penetration. For example, if the instrumental surgery is expected to be directly or indirectly in contact with the liquid or flushing fluid, all areas are key areas.