Technical review of the registration of respiratory lines for anesthesia machines and ventilators
Guidelines for the preparation of descriptions

1. the purpose of the preparation

(1) The purpose of these Guidelines is to guide and standardize the technical review of the registration materials by examiners in the process of registration and declaration of respiratory pipeline products for anesthesia machines and ventilators.

(2) These Guiding Principles are intended to allow the registration examiners who are new to such products to have a basic understanding of the product structure, main performance, intended use and other aspects, and at the same time to enable technical examiners to grasp the basic scale during the technical review of product registration and make a systematic evaluation of product safety and effectiveness.

2. Basis for the preparation of the Guiding Principles

(1) Regulations on the Supervision and Administration of Medical Devices;

(2) Measures for the Administration of The Registration of Medical Devices (Bureau Order No. 16);

(3) Measures for the Administration of Medical Device Standards (Bureau Order No. 31);

(4) Provisions on the Administration of Instructions, Labels and Packaging Identification of Medical Devices (Decree No. 10 of the Bureau);

(5) Notice on Printing and Distributing the Operational Specifications for the Registration and Approval of Domestic Class Medical Devices (Trial Implementation) and the Code of Practice for the Registration and Approval of Domestic Class Medical Devices (Trial Implementation) (National Food and Drug Administration [2005] No. 73);

(6) Notice on Printing and Distributing the Catalogue of Class X Medical Devices Exempted from Submitting Clinical Trial Data (Trial Implementation) (National Food and Drug Administration [2011] No. 475);

(7) Other normative documents issued by the State Food and Drug Administration;

(8) Relevant existing national and industry standards.

III. Consideration of the preparation of some specific elements of the Guiding Principles

(A) the main technical indicators of the product to develop the main reference to the industry standard YY0461-2003 "anesthesia machine and ventilator with respiratory pipeline".

(2) The intended use of the product is based on YY0461-2003 "Respiratory Tubes for Anesthesia Machines and Ventilators". Combined with the opinions of clinical experts, the expected use is for anesthesia machines and ventilator respiratory lines and anesthesia machines, ventilators, tidalizers, and sprayers to establish a respiratory connection channel for patients.

(3) According to the structure described in YY0461-2003 "Respiratory Pipeline for Anesthesia Machines and Ventilators", it can be divided into single-pipe type and double-pipeline type; according to clinical needs, the structure and material of the breathing pipeline will be different, such as the common double-pipe reinforcing rib type, the double-pipeline retractable type, the double-pipeline reinforced rib accumulation cup type, the double-pipeline retractable water cup type, etc. The flexibility of the double-pipe reinforced pipe body is relatively good, it is not easy to discount, and the airflow resistance is small. The double-tube retractable type is a free way to adjust the distance between the anesthesia machine or ventilator and the patient, reducing the trouble caused by the entanglement of the breathing line. The water-filled cup in the double-line water-containing cup type is used to treat the condensation in the pipeline and keep the pipeline normally ventilated, reducing the risk of liquid entering the ventilator through the pipeline or the patient's respiratory tract.

4. Guidelines for the authors

The personnel who compile these guiding principles are composed of medical device administrative personnel, registered technical review personnel, medical device inspectors, clinical experts and relevant enterprise technical personnel in Henan Province. In order to make full use of all aspects of information and resources, comprehensively consider the content of all aspects of the guiding principles, and try to ensure that the guiding principles are correct, sufficient and practical.

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