Functionality is the performance test of the wearable device. With reference to the items specified in IEC 60601-2-47, each of the ECG standards is regulated. Functionality is a test of artificial signals such as triangle waves and sine waves, but not real physiological signals. Before testing, you must confirm the purpose, definition, environment, equipment, process, and other applicable scope of the test item. Use the output signal of the erected detection system for testing. The test environment must follow the reference standards and functional tests. The performance items of which the ECG performance test is divided into eight inspection items as follows:

(1) Linearity and dynamic range: Detects the signal receiving range of the wearable smart device, such as frequency and amplitude range.

(2) Common mode rejection: Detects the common mode rejection ratio capability of wearable smart devices.

(3) Gain Accuracy: Detects the accuracy of the signal amplification function of the wearable smart device.

(4) Gain Stability: Detects the stability of wearable smart device signal amplification function over a long period of time.

(5) Multichannel Crosstalk: Detects the anti-interference ability of different channels in the case of multi-channel wearable smart devices.

(6) Input Impedance: Detects the input impedance of the wearable smart device.

(7) Frequency Response: Detect the impact of wearable smart devices at different frequencies.

(8) System Noise: Detects system noise of wearable smart devices.

　　Stability is the detection of actual signals. The heart rate test is mainly the common functional item wearable ECG. Heart rate detection is an item regulated by IEC 60601-2-47 and ISO 80601-2-61. There are static heart rate measurement, dynamic heart rate measurement, database heart rate measurement and heart rate variability measurement, among which the database is adopting by international standard databases (MIT-BIH Database, AHA Database, NST Database, etc.) which contains ECG arrhythmia waveform, and all heart rate detection can be divided into artificial signals, physiological signals, special tests, etc The three tests are detail described below:

(1) Artificial signal

　(1-1) ECG fixed heart rate accuracy: Heart rate accuracy under simulated ECG signals.

　(1-2) ECG heart rate variability accuracy: The accuracy of heart rate variability calculation under simulated ECG signals.

(2) Physiological signals

　(2-1) ECG has a reference annotation heartbeat database data: Calculate ECG signal heart rate function in Database data.

　(2-2) ECG dynamic heart rate detection accuracy: The heart rate accuracy of physiological ECG signals under dynamic conditions.

(3) Special test

　(3-1) Under different vibration frequencies and assembly states of the test device, the signal measurement and noise generation test verified by the different situation.

　　Unlike traditional electronic motor products, wearable smart devices need to focus more on direct and long-term contact with the skin, which may pose a risk of allergies to consumers. In order to avoid problems affecting the brand image, product recalls, compliance with standards and consumer safety requirements. Safety tests need to be performed and biocompatibility items specified in ISO 10993 should be followed. The compatibility test is mainly to ensure that the wearable device products that directly or indirectly contact the human body will not release toxic substances during use, causing local or systemic cytotoxicity, carcinogenicity or reproductive toxicity, which will cause the human body to cause inflammation, immunity, toxic reactions, hemolysis, thrombotic reactions and other hazards.

(1) Physical and chemical properties of materials

　　Whether the physical and chemical properties of the wearable device material are harmful to the human body must be in accordance with ISO 10993-9, ISO 10993-13 (polymer), ISO 10993-14 (ceramics), and ISO 10993-15 (metals and alloys) To identify possible degradation products and quantify them. A toxicological assessment of all extractable substances and degradation products identified should be performed to predict the toxicological risks that the medical device being evaluated may pose during use.

(2) Skin sensitization

　　Whether the skin-sensitive reaction of the wearable device under prolonged contact occurs for the following three explanations. 

　(2-1) Ingredient review through ingredient list and safety data sheet (SDS) to find potential skin irritants and allergens. 

　(2-2) Toxicologists perform exposure assessments based on the actual use of the product.

　(2-3) Perform a series of checks, including in vitro assays and chemical analysis.

　(2-4) Carry out skin irritation and allergy risk assessments based on test data and evidence-weighted methods of exposure assessment.