Standardized assembly process
1. Incoming material inspection
Verify accessories:
✓ Supplier's "Medical Device Registration Certificate"
✓ COA (inspection report) and biological performance report for each batch
✓ Accessory size (such as Luer connector in accordance with ISO 80369)
2. Clean area assembly
Environmental control: temperature 18-28℃, humidity 45%-65%
Key processes:
Heat sealing of dropper and pipeline (to verify sealing)
Filter installation (100% bubble point test required)
Lurer connector torque test (0.5-1.2N·m)
3. Process inspection
Sampling every 2 hours:
Flow accuracy (±5% error)
Leak test (no leakage under 50kPa pressure)
4. Terminal processing
Sterilization: EO sterilization (if provided sterile) → analytical residue (≤10μg/g)
Packaging: primary packaging must pass ISO 11607 sealing verification
Standardized assembly process
1. Incoming material inspection
Verify accessories:
✓ Supplier's "Medical Device Registration Certificate"
✓ COA (inspection report) and biological performance report for each batch
✓ Accessory size (such as Luer connector in accordance with ISO 80369)
2. Clean area assembly
Environmental control: temperature 18-28℃, humidity 45%-65%
Key processes:
Heat sealing of dropper and pipeline (to verify sealing)
Filter installation (100% bubble point test required)
Lurer connector torque test (0.5-1.2N·m)
3. Process inspection
Sampling every 2 hours:
Flow accuracy (±5% error)
Leak test (no leakage under 50kPa pressure)
4. Terminal processing
Sterilization: EO sterilization (if provided sterile) → analytical residue (≤10μg/g)
Packaging: primary packaging must pass ISO 11607 sealing verification
