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Detailed Standard Operating Procedures (SOPs) are developed for each process, clearly defining key parameters such as welding current, bending angle, and assembly gaps.
"First-piece inspection, patrol inspection, and last-piece inspection" are implemented for processes such as welding, heat treatment, and surface treatment; pipes undergo a 180℃, 4-hour constant-temperature aging treatment after welding.
Online monitoring points are set up, and key equipment such as welding machines and bending machines are calibrated regularly.
Each batch of products is assigned a unique batch number, recording information such as raw materials, production personnel, and equipment.
100% inspection, with no scratches, burrs, or welding defects on the surface; critical dimensional tolerances (such as wheel axle hole deviation ≤ 0.05 mm).
| Test Items | Indicator Requirements | Static Load Capacity | Load 1.5 times the rated load (e.g., 100 kg → 150 kg), hold for 5 min, deformation ≤ 2 mm |
| Frame Fatigue | 80 kg Counterweight, 200,000 Rolling Cycles, No Frame Cracks | Stabilized Braking | 6° Slope: Brake Remains Stationary for ≥ 5 min, Displacement ≤ 10 mm |
| Dynamic Braking | Downhill Braking Distance ≤ 1 m at 6 km/h | Brake Durability | Brake Operations ≥ 10,000 Cycles |
| Frame Fatigue | 80 kg Counterweight, 200,000 Rolling Cycles, No Frame Cracks | Stabilized Braking | 6° Slope: Brake Remains Stationary for ≥ 5 min, Displacement ≤ 10 mm |
| Dynamic Braking | Downhill Braking Distance ≤ 1 m at 6 km/h | Brake Durability | Brake Operations ≥ 10,000 Cycles |
Supplier Selection:
Suppliers certified to ISO 13485 or ISO 9001 are given priority, and on-site audits are conducted.
Incoming Quality Control (IQC):
Metal Components: Testing material composition (e.g., 6061 T6 aluminum alloy), wall thickness tolerance (±0.1 mm), hardness, and tensile strength; frames commonly use Q235 steel, high-strength aluminum alloy, or 6061/6063 aluminum alloy tubing.
Plastic/Rubber Components:
Testing impact strength, RoHS compliance, weather resistance, and abrasion resistance; seat fabric is often 600D Oxford cloth with flame retardancy.
Fasteners:
Verifying strength grade (e.g., 8.8 grade screw tensile strength test) and anti-loosening performance.
Non-conforming Product Handling:
Rejecting non-conforming products, requiring suppliers to rectify and close the loop.
Similar to wheelchairs, detailed Standard Operating Procedures (SOPs) are required.
100% online testing of electrical safety (withstand voltage, insulation) is added; welding, painting, and circuit assembly also implement "first piece inspection, patrol inspection, and last piece inspection."
Risk management for hospital beds (especially electric beds) is more complex, requiring compliance with GB 9706.1, monitoring of the anti-static environment, and calibration of all testing equipment.
Each hospital bed is assigned a unique serial number, ensuring full traceability throughout the entire process.
Stabilized Load Capacity:
Under 1.5 times the rated load (e.g., 150 kg → 225 kg), after holding the load for 1 hour, the bed surface deformation ≤ 2%, with no structural damage.
Guardrail Strength:
Impacted by a 10 kg sandbag from a height of 100 mm, the guardrail shows no breakage, with deformation ≤ 5 mm.
Bed Stability:
With a bed tilt ≥ 15° and a 75 kg load, there is no tipping over, and displacement ≤ 10 mm.
Insulation resistance:
≥ 2 MΩ between live parts and the enclosure (tested at DC 500 V).
Dielectric strength:
AC 1500 V for 1 minute; no breakdown; leakage current ≤ 5 mA.
Grounding continuity:
Resistance between the metal enclosure and the grounding terminal ≤ 0.1 Ω.
Battery endurance:
Continuous operation for ≥ 8 hours at maximum load with a full charge.
Surface corrosion resistance (salt spray):
5% NaCl, 240 hours; no rust; coating adhesion ≥ Grade 1.
Flame retardancy:
Burning rate of non-metallic materials ≤ 100 mm/min, or self-extinguishing within 10 seconds of contact with an ignition source.
VOC emissions:
Formaldehyde ≤ 0.08 mg/m³; TVOC ≤ 0.5 mg/m³.
Biocompatibility:
Materials in direct contact (e.g., mattress covers) must pass cytotoxicity testing; cell viability ≥ 70%.
Disinfectant resistance:
No discoloration, corrosion, or cracking of surface materials after wiping.
Vibration and shock testing (e.g., ASTM D999-01):
Simulated transport to ensure product integrity.
