YY/T 0325-2022Sterile urethral catheter for single use (English PDF)

National Standard of the People's Republic of China

Replacing

YY 0325-2016

Issued by: National Medical Products Administration of the People's Republic of China

Contents

• 1 Scope
• 2 Normative references
• 3 Terms and definitions
• 4 Intended performance
• 5 General requirements
• 5.1 Risk management
• 5.2 Biocompatibility
• 5.3 Detectability
• 5.4 Appearance
• 5.5 Size designation
• 5.6 MRI compatibility
• 5.7 Connectors
• 5.8 Sterilization
• 5.9 Residual ethylene oxide (EO)
• 6 Particular requirements
• 6.1 Strength
• 6.2 Safety of the connector
• 6.3 Reliability of the balloon
• 6.4 Integrity of the inflation lumen of the catheter and maintenance of the volume
• 6.5 Flow
• 6.6 Corrosion resistance
• 6.7 Kink stability
• 6.8 Peak tensile force
• 6.9 Tensile strength of the inflated balloon
• 7 Information supplied by the manufacturer
• 7.1 General
• 7.2 Marking of the product and of the packaging
• 7.3 Instructions for use
• Annex A (normative) Test method for the strength of the urinary catheter
• Annex B (normative) Test method for the assembly safety of the drainage conical connector
• Annex C (normative) Test method for the reliability of the balloon
• Annex D (normative) Test method for leakage of the inflation lumen and for function and balloon deflation (catheters with a compliant balloon)
• Annex E (normative) Test method for the reliability of the deflated balloon dimensions (catheters with a non-compliant balloon)
• Annex F (normative) Test method for the measurement of the flow of the urinary catheter
• Annex G (normative) Test method for corrosion resistance
• Annex H (informative) Test method for kink stability
• Annex I (normative) Test method for the measurement of the peak tensile force of the urinary catheter
• Annex J (normative) Test method for the measurement of the tensile strength of the balloon
• Bibliography