This clause is based on the technical requirements in YY 0461-2003 "Anesthesia Machine and Ventilator Respiratory Circuit", and combined with the actual structure of the product, if the following technical indicators are not applicable, the reasons should be explained in the registration standard preparation instructions.

1. Product model, specification, size

It should be specifically prepared by the enterprise in the registered product standard according to the actual product. The length measurement unit, marking, tolerance, etc. should meet the requirements of YY 0461-2003 4.4, 4.8.

2. Airflow resistance

Enterprises should clearly indicate the rated flow rate in the registered product standard, and the increase in airflow resistance and bending airflow resistance under the rated flow rate should meet the requirements of YY 0461-2003 in 4.5 and 4.8.

3. Connection method

The connection method of the smooth end of the breathing line, the conversion joint, the assembly end, the breathing circuit with a Y-shaped part, etc., should meet the requirements of YY 0461-2003 4.6.

4. Leaks

The leakage rate and tolerance of various types of breathing lines should meet the requirements of 4.7 in YY 0461-2003.

5. Compliance

The compliance requirements should comply with the requirements of YY 0461-2003 4.9.

6. Electrostatic prevention

The components of the antistatic breathing circuit and its connection shall comply with the electrostatic prevention requirements specified in GB9706.1-2007 39.3 b).

7. If the respiratory circuit is used repeatedly, the following information should be specified in the registration standard:

a) a significant number of times and times of repeated use and should meet the requirements of the registration criteria within its recommended lifespan;

YY 0461-2003 "Respiratory Tubes for Anesthesia Machines and Ventilators" YY 0461-2003"Breathing Circuits for Anesthesia Machines and Ventilators"

b) Recommend common cleaning, sterilization and sterilization methods.

8. If the breathing circuit is used for single use, it should be sterile supplied and the sterile expiration date shall be specified. If ethylene oxide sand bacteria are used, the residual amount of ethylene oxide should also be specified.

9. According to the composition of the product structure, the performance requirements of each component should also be formulated in the registration standard.

10. The materials used in the breathing circuit shall meet the requirements of biological safety tests stipulated in GB/T 16886.1.

YY 0461-2003 "Respiratory Tubes for Anesthesia Machines and Ventilators" YY 0461-2003"Breathing Circuits for Anesthesia Machines and Ventilators"