Tests Required for Sterilization Wrap — FDA 510(k)

The specific tests required for a sterilization wrap for 510(k) submission will depend on the type of wrap and its intended use. However, here are some standard tests that may be required:

Sterilization Wrap 510k – Test Requirements.

1. Biocompatibility Testing:
   • Skin Irritation ISO – 10993-23
   • Sensitization ISO – 10993-10
   • Cytotoxicity ISO – 10993-5
   • Sterilization Residuals ISO – ISO 10993-7
2. Sterilization Validation
   • ANSI/AAMI/ISO 11135:2014 Sterilization of health care products – Ethylene oxide
   • ANSI/AAMI/ISO 11137-1:2006/(R)2010, Sterilization of health care products – Radiation
3. Shelf Life and Expiry Date
   • Shelf-life test protocol, study plan, and reports
4. Performance Testing
   • AATCC 127 – Hydrostatic pressure
   • ISO 11607 – Requirements for materials
   • ASTM D5587-15 – Tearing Strength
   • ASTM D5034-09 – Breaking Strength and Elongation
   • ASTM D737-18 – Air Permeability
   • ASTM D3776/D3776M – Mass per Unit area (Weight)
   • ASTM D3786/D3786M-18 – Bursting Strength
   • ASTM F2101-19 – Bacterial Filtration Efficiency (BFE)
   • DIN 58953 – Microbial Barrier Test

It’s important to note that the specific tests required may vary depending on the intended use of the sterilization wrap. It’s best to consult with FDA Consultant to determine the exact testing requirements for your specific sterilization wrap.

LMG Provides assistance to sterilization wrap manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements. Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

• Prepare 510k notification.
• Submission of 510k notification.
• FDA Agent service for 510k submission.
• Guidance in test requirements.
• Register your establishment with FDA.
• List your sterilization wrap with FDA.