Quality & Compliance
Certified Quality, Documented Compliance
Every Kangde Med product is manufactured under an ISO 13485 quality management system and designed to the international standards that govern sterilization indicators and sterile barrier systems.
Standards We Manufacture To
| ISO 13485 | Quality Management System for Medical Devices |
|---|---|
| ISO 11140 | Chemical Indicators for Sterilization Processes |
| ISO 11607 | Packaging for Terminally Sterilized Medical Devices |
| EN 868-5 | Sealable Pouches & Reels of Porous Materials |
| CE | Compliant with EU Requirements |
| ISO 11140-1 Types | Type 1 (tapes), Type 4, Type 5 and Type 6 (strips) for steam, EO, H₂O₂ plasma and formaldehyde |
| ISO 11607-1 / EN 868-5 | Pouches and reels — microbial barrier, seal strength, peel and burst performance |
Quality System in Practice
- Incoming inspection of medical-grade paper, films, adhesives and indicator inks against specification, with supplier certificates retained.
- In-process control of seal strength, print registration, indicator colour density and roll dimensions at defined intervals.
- Final release testing — indicator performance in reference sterilization cycles, peel and burst tests for pouches and reels — before every lot is released.
- Lot traceability — every carton carries a lot number linking to raw-material and inspection records.
- Documentation — certificates of conformity, declarations and test reports supplied with shipments on request.
Certificates
Request Documentation
Need certificates, declarations of conformity or test reports for your validation file or tender? Send us the product list and we will provide the current documents.
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