TX Q&A

Pyrogens refer to substances that can cause fever in the body, including information on materials causing fever and bacterial endotoxin-induced fever, which are part of biological evaluation projects. Bacterial endotoxins are lipid polysaccharide components released from the cell wall of Gram-negative bacteria after death and autolysis, typically originating from biological contamination introduced during production, and are not part of biological evaluation projects. Generally, bacterial endotoxins are pyrogens, but not all pyrogens are bacterial endotoxins.

Typically, all accessories in the equipment, cable layout, and typical configurations used in electromagnetic compatibility testing should be consistent with normal use. If it is determined through analysis that the passive accessories are not relevant to electromagnetic compatibility testing, then there is no need to test them along with the passive accessories. However, if testing with the passive accessories is necessary to achieve its basic performance, then the testing should be done with those passive accessories.

Microbial invasion tests should simulate repeated clinical use. The types and quantities of microbes used in the test should be similar to the potential infecting microbes at the entry site of medical devices used clinically. It is recommended to use 2 types of Gram-negative bacteria and 2 types of Gram-positive bacteria, with at least 1 type of each. The selected microbes for the test should be common microbes that cause infusion-related infections in clinical settings. Reference can be made to the "Guidelines for the Prevention and Treatment of Catheter-Related Infections" (issued by the Chinese Society of Critical Care Medicine) for selection.

If medical optical endoscopes and laser fibers do not contain electronic components inside, only optical components, then they do not need electromagnetic compatibility testing. If they contain electronic components inside (such as RFID recognition devices), then electromagnetic compatibility testing is required.

Whether it's a specialized or a general-purpose endoscope camera system, they should be classified into separate registration units from the endoscope.

1. Based on the fixation mechanism, they can be divided into two registration units: intramedullary nails with locks and intramedullary nails without locks, with structures detailed in YY/T 0727.1 and YY/T 0019.1. Intramedullary nail products have a different structure from intramedullary needle products and belong to different registration units. 2. With different constituent materials (including material grades), they are categorized into separate registration units. Based on the commonly used metal materials for intramedullary nails, they can be divided into TC4 titanium alloy, TC4ELI titanium alloy, TC20 titanium alloy, 00Cr18Ni14Mo3 stainless steel, and other registration units. If the constituent materials of the products differ but are used as an integrated assembly or combination, they can be declared under the same registration unit.

The sample operating mode should identify the maximum emission operating mode. It should comprehensively and thoroughly identify the "functions" as defined in YY 0505-2012, conduct robustness testing for each identified function, and perform robustness testing in the least favorable manner for patient impact.

"Basic performance" refers to essential performance to achieve no unacceptable risks, considering whether its loss or reduction would lead to unacceptable risks. When determining the product's basic performance, the manufacturer should consider, but not limited to, the following aspects: analyzing clinical safety risks, considering performance related to diagnosis/treatment/monitoring, whether various sensors, cables, application parts, control devices, display units, moving parts, etc., are affected by electromagnetic interference. The basic performance identified in the relevant documents should be tested for robustness. If basic performance is not identified in the documents, all functions should be considered for robustness testing.

All products within the declared registration unit (including all models and components) should be submitted as samples. These samples can either all undergo testing or be analyzed by the inspecting engineers at the testing center, who will select representative samples for testing. The electromagnetic compatibility test report should clearly state the information of the submitted and tested products. The conclusion of the electromagnetic compatibility test report should specify whether the submitted products meet the electromagnetic compatibility requirements and standards. For certain accessories included with the samples, if they are deemed irrelevant to the electromagnetic compatibility test by the inspecting engineers, the report should clearly mention these accessories and the analysis conclusion. The information of these accessories does not need to be included in the sample composition table.

The electromagnetic compatibility test report should be correlated with the electrical safety inspection report to ensure the consistency of the samples being tested.