Medical-Grade Chrome Plated Steel Bar Cleaning Standards
Sterility Assurance • Chemical Safety • Particulate Control
Medical device cleaning requires strict adherence to sterility, chemical residue-free, and particulate-free principles. Our chrome plated steel bars meet the highest medical standards through comprehensive cleaning protocols.
1
Standardized Cleaning Process
Pre-Cleaning
- Use soft nylon brushes (no metal) with 37-40℃ medical-grade purified water (conductivity ≤1.3μS/cm)
- High-pressure water guns (≤5MPa) or ultrasonic cleaning (40kHz, 5-10 min) for complex structures
Chemical Cleaning
Non-Surgical Instruments
Neutral enzyme cleaner (pH 7.5-8.5) at 50-60℃ for 15-20 min
Surgical Instruments
1-3% NaOH (70-80℃) for 10 min, rinse to pH 5.5-7.5
2
Surface Cleanliness Control
Particle Contamination (ISO 11135)
Detected by laser particle counter or microscope (100x)
Chemical Residues
Heavy Metals
Cr ≤0.1ppm
Ni ≤0.5ppm
Surfactants
≤0.01mg/m² (LC-MS)
3
Special Scenario Requirements
Implantable Devices
- ISO Class 5 clean room
- USP purified water standards
- Double-layer sterile packaging
Mucosa-Contact Instruments
- Endotoxin testing required
- ≤0.5EU/mL (LAL method)
4
Cleaning Validation & Records
Record Keeping
Complete batch records retained ≥5 years, compliant with FDA 21 CFR Part 11
Need detailed medical cleaning specifications or validation protocols?
Contact Our Medical Standards Team
