Description
| Parameter. | |||
| Outer Dimensions | 1100 mm*1240 mm* 1950 mm | Basic Accuracy of Electronic Scale | 0.001 g |
| Testing speed | 6-8 pcs/minute | Software Control Method | PC |
| Feeding Method | Manual | Software Human-Machine Interaction | Industrial controller |
| Input Air Pressure | ≥0.6 MPa | Product Information Recording Method | Barcode Scanner |
| Input Voltage | AC 220V,50Hz | Operating Temperature | 20±5℃ |
| Cleanliness | Inside the equipment<Class 100,000 | Operating Relative Humidity | 30%-60% non-condensing |
| Data Detection Method | pressure sensor,vision inspection,electronic scale | Air Environment | No dust,flammable,explosive,or corrosive gases |
| Basic Accuracy of Sensors | 0.2N | Working System | Continuous |
| Basic Accuracy of Vision | 0.02 mm | Safety Protection | Safety door lock+dual start buttons+ safety light curtain+ emergency stop switch |
| Test Item | Description | Standard | Accuracy | Reference Standards |
| Cap Removal Force | Minimum force required to remove the pen cap | 6-55N | 0.2N | ISO 14971, YBB40012012 |
| Activation Force | Minimum force required to press and start the injection process | 2-15N | 0.2N | ISO 11608-5, ISO 14971 |
| Trigger Force | Force required to initiate injection | 2-15N | 0.2N | ISO 11608-5, ISO 14971 |
| Holding Force | Force to maintain the injection process | 2-15N | 0.2N | ISO 11608-5, ISO 14971 |
| Rebound Force | Inner shell rebound force after injection completed | > 0N | 0.2N | ISO 11608-5, ISO 14971 |
| Defeat Force | Minimum force required to break the needle cap protection device through vertical pressing | > 48N | 0.2N | ISO 11608-5, ISO 14971, ISO 23908 |
| Injection Volume | Weight of collected liquid after injection | > 1 ml | 0.001g | ISO 11608-1, ISO11608-5, YBB40012012, ISO 14971 |
| Injection Time | Time interval from plunger start to stop moving | 5-10s | 0.04s | MDER 2015:8 437-484 |
| Needle Penetration Depth | Injection depth | 4-8 mm | 0.02 mm | ISO 11608-5, ISO 14971 |
| Needle Safety Distance | Needle tip protection distance after injection | ≥ 3.7 mm | 0.02 mm | ISO 11608-5, ISO 23908
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| Equipment Advantages | |||
| A single device completes all test items,complying with regulatory requirements for traceable and auditable data. | |||
| Suitable for in-process control during production and for the release of finished products. | |||
| Compatible with products from mainstream international medical device manufacturers. |
