Audited Supplier
HL903
Automatic Testing
6-8PCS/Min
Acceptable
Manual
Container
1100mm*1240mm*1950mm
China
Product Description
Device Features
- One pen for all test items and complied with regulatory requirements
- Test data can be traced and audited
- Can be used for production in- process control and product development
- Compatible with the products from main international manufacturers
| Testing Machine | Parameter value |
| External Dimension | 1100mm*1240mm*1950mm |
| Speed | 6-8pcs/min |
| Feeding Mode | Manual |
| Input Pressure | ≥0.6MPa |
| Input Voltage | AC 220V 50Hz |
| Cleanliness | <100,000 class in equipment |
| Data Detection Method | Pressure sensor,visual inspection,electronic scales |
| Sensor Basic Accuracy | 0.2N |
| Vision Basic Accuracy | 0.02mm |
| Basic Precision of Electronic Scales | 0.001g |
| Software Control Methods | PC |
| Software Human Machine Interaction | Industrial controller |
| Product Information Recording Methods | Scanner |
| Operating Temperature | 20±5°C |
| Operating Relative humidity | 30-60 percent non-condensation |
| Air Environment | No dust,flammable and explosive,corrosive gases |
| Working System | Progression |
| Safety Protection | Safety door lock+dual start button+safety light curtain+emergency stop switch |
Testing Items
| 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 |
