YY/T 1730-2020 in English

Standard Background and Scope of Application

YY/T 1730-2020 was issued by the National Medical Products Administration on June 30, 2020 and implemented on June 1, 2021, replacing the original industry standard. This standard specifies the technical requirements, test methods and marking requirements for disposable hemodialysis catheters, and is applicable to single-use arteriovenous hemodialysis catheter products.

Key Technical Requirements

Analysis of key test methods

1. Connection strength test

According to GB/T 1962.2, the tensile testing machine is used to stretch at a speed of 20mm/min. The separation force between the catheter and the connector should meet the following requirements:

• Arterial end ≥15N
• Venous end ≥10N

2. Particle contamination control

Referring to the requirements of GB 8368, 300mL flushing solution is used to collect particles. The optical microscope count should meet the following requirements:

Comparison of technological evolution

Main changes compared with the 2015 version of the standard:

1. Added the definition and measurement method of effective catheter length
2. Increased the connection strength requirement (the original standard was 8N)
3. Refined the sampling method for particle detection

Clinical implementation recommendations

1. Key points for product selection

• Give priority to conical connector design (in line with GB/T 1962.2)
• Pay attention to the matching of the effective catheter length with the patient's body shape

2. Key points for quality control

• The stability of injection molding parameters needs to be monitored during the production process
• Connection strength verification needs to be performed for each batch
• The EO residual amount (≤10μg/g) needs to be verified during the sterilization process

3. Prevention of adverse events

According to the requirements of YY/T 0285.1, the main preventive measures for catheter breakage are:

• Avoid sharp-angle bending (minimum bending radius ≥5cm)
• Reuse is prohibited