Guidelines for the Technical Review of The Registration of Respiratory Lines for Anesthesia Machines and Ventilators

The purpose of these guiding principles is to guide and standardize the technical review of the breathing circuits for anesthesia machines and ventilators, to help reviewers understand and grasp the structure, performance, intended use and other contents of such products, to grasp the basic requirements and scale of technical review work, and to systematically evaluate the safety and effectiveness of products.

The core content identified in these Guiding Principles is based on the current level of scientific and technological awareness and existing product technologies, so reviewers should pay attention to their suitability, pay close attention to new developments in applicable standards and related technologies, and consider product updates and changes.

These Guidelines are not enforceable as regulations and do not include administrative approval requirements. However, reviewers need to pay close attention to changes in the relevant regulations to confirm whether the declared products meet the regulatory requirements.

1. Scope of application

The scope of application of these Guiding Principles is the class ** anesthesia machine and ventilator respiratory pipeline products in the Classification Catalogue of Medical Devices, and the class code is 6866.

Ii. Key points of the technical review

(1) Requirements for product names

The nomenclature of breathing pipeline products for anesthesia machines and ventilators shall be named according to the generic names in the Classification Catalogue of Medical Devices, national standards, industry standards, or on the basis of product structure and scope of application. Product names can also have descriptive words that indicate the material, such as "PVC". If it is "disposable", the name should be preceded by the word "disposable".

(2) The structure and composition of the product

According to the structure described in YY 0461-2003 "Respiratory Lines for Anesthesia Machines and Ventilators", it can be divided into single-line type (see Figure 1) and double-line type (see Figure 2). According to the clinical needs, the structure and material of the breathing line will be different, for example, the common double-pipe reinforcing type (see Figure 3), the double-pipe retractable type (see Figure 4), the double-pipe reinforcing rib cup type (see Figure 5), the double-pipeline retractable water cup type (see Figure 6) and so on.

(3) The working principle of the product

1. Single-pipe type

A single line is to create a one-way gas channel between the anesthesia machine or ventilator and the mask. The gas output of the anesthesia machine or ventilator is transported through a breathing valve into the mask for the patient to inhale, and the exhaled gas from the patient is discharged through the mask.

2. Double pipe type

A double-line circuit is used to establish a breathing connection channel between an anesthesia machine or ventilator and the patient. One of the lines is to transport the gas output by the anesthesia machine or ventilator to the patient, and the other is to discharge the exhaled gas from the patient through the anesthesia machine or ventilator.

A pipe containing a cup of water, which is used to treat condensation in the line and keep the line ventilated normally, reducing the risk of fluid entering the ventilator or the patient's airway through the line.

(4) The mechanism of action of the product (omitted)

(5) Relevant standards applicable to the product

Table 1 Related product standards

The above standards include the standards involved in the registered product standards. Some companies will also cite some standards outside the industry and some special standards according to the characteristics of the product.

The review of product applicability and citation standards can be carried out in two steps. First of all, the completeness and appropriateness of the citation standard are reviewed, that is, whether the national standards and industry standards related to the product are cited and whether the citations are accurate when writing the registered product standards. It can be examined by examining whether the relevant standards are cited in the chapter "Normative Reference Documents" of registered product standards and whether the standards cited are appropriate. Attention should be paid to whether the standard number, the standard name is complete and standardized, and whether the era number is valid. Second, the adoption of the citation criteria is reviewed. The terms in the referenced standard require that there be a substantial reference to the terms in the registered product standard. This kind of citation usually adopts two ways, the text expression is complex and complex content can directly quote the standard and the article number, and the relatively simple can also directly quote the specific requirements.

Note the difference between the standard references or references to relevant standards and materials in the "Normative Citation Document" and the "Standard Preparation Instructions", and those that are generally not suitable for direct reference are not included in the normative citation documents, but only appear in the standard preparation instructions with reference documents.

If there is a new version of the national standard or industry standard released and implemented, it should be implemented.

(f) the intended use of the product

Anesthesia machines and ventilator breathing lines are used in conjunction with anesthesia machines, ventilators, tidalizers, and sprayers to establish a respiratory connection channel for patients.

(7) The main risks of the product

1. Risk analysis methods

(1) In the determination and analysis of risks, reasonable and foreseeable risks should be considered, including: normal use conditions and abnormal use conditions.

Guidelines for the Technical Review of the Registration of Respiratory Products for Anesthesia Machines and VentilatorsThe Guidelines for the Registration of Products for Anesthesia Machines and VentilatorsThe Guiding Principles for the Technical Review of the Registration of Products for Anesthesia Machines and VentilatorsThe Guidelines for the Registration of Products for Anesthesia Machines and VentilatorsThe Guiding Principles for the Technical Review of the Registration of Products for Ventilators and Ventilators