Product Classification

• Device: sterilant, medical devices
• Regulation Description: Liquid chemical sterilants/high level disinfectants.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MED
• Submission Type: 510(k)
• Regulation Number: 880.6885
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI ST58:2005/(R)2010 Chemical sterilization and high-level disinfection in health care facilities
• AOAC 6.2.04:2009 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
• AOAC 6.3.06:2008 Official Method 965.12, Tuberculocidal Activity of Disinfectants
• AAMI/ANSI/ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
• ISO 14160 Second edition 2011-07-01 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
• AOAC 6.2.01:2012 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
• AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
• AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
• AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
• AOAC 6.2.06:2012 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
• AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
• AOAC 6.3.05:2006 Official Method 966.04, Sporicidal Activity of Disinfectants Method I

Guidance Document

• Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.