Sheet metal assembly of endoscopes, patient monitors and MRI equipment has mandatory regulatory cleanliness requirements for clinch fasteners. Ordinary industrial clinch parts with residual cutting oil and tiny iron debris cause sensor short circuit and massive imaging artifacts after assembly. Class II & Class III medical devices must attach cleanliness test reports before delivery. Yamaoluomu specializes in medical precision clinch parts and establishes graded cleanliness control system.
| Cleanliness Grade | Max Oil Residue Per Piece | Allowable Metal Debris Particle Size | Standard Cleaning Process | Packaging Cleanroom Class | Applicable Medical Devices |
| General Industrial Grade | ≤5μg per piece | ≤0.1mm | 1-stage ultrasonic rinse with tap water | Class 100,000 ordinary workshop | Home simple physical exam instruments, small detection equipment without imaging function |
| Class II Medical Device Grade | ≤1μg per piece | ≤0.05mm, no free metal particles | 3-stage degreasing + multi-stage pure water rinse + vacuum drying | Class 10,000 dust-free subpackaging workshop | Portable endoscopes, hospital bed monitors, home physiotherapy equipment |
| MRI Sterile Non-magnetic Grade | ≤0.1μg per piece, zero organic residue | Zero tolerance for any metal debris | Food-grade degreasing, ultra-pure water ultrasonic, nitrogen vacuum drying | Class 1,000 independent packaging station | MRI supporting sheet metal, intraoperative portable imaging equipment |
1. Production isolation: Stamping & static pressing stations for medical parts are physically separated from industrial products with exclusive tooling; carbon steel molds mixing is forbidden to avoid iron debris contamination; 2. Graded cleaning rule: MRI grade products adopt ultra-pure water with resistivity ≥18.2MΩ·cm to prevent water impurities adhering to threads; 3. Drying standard: Full low-temperature vacuum drying, circulating hot air drying is prohibited to avoid secondary dust adhesion; 4. Independent packaging workflow: Single size vacuum sealed bags packed in Class 1000 cleanroom with dust-free desiccant, double-layer PE dust-proof outer cartons.
1. Excessive oil residue: Re-run full degreasing cleaning process, replace expired tank liquid and install activated carbon filter device; 2. Visible metal debris on surface: Full manual sorting re-inspection, add sticky dust mats on workshop floor, polish tooling daily to remove iron filings; 3. Trace magnetic dust detected on MRI accessories: Isolate full batch for re-demagnetization & ultra-pure water cleaning, iron tools are banned inside Class 1000 clean zone.
Contact: Mr. Deng
Phone: 13928071304
Tel: 0756-8586520
Email: lizhong@zhjiali.com
Add: 102, Building 4, No. 4 Fuyuan Road, Waisha Village, Shenwan Town, Zhongshan City, Guangdong Province,China