Prevention and control of Influenza A H1N1 influenza medical devices one of the regulatory requirements:

Medical protective masks

【Management】 Based on the "one-time protective clothing on medical products such as classification of the notice" (State Food and Drug Administration Arsenal [2003] 57), medical protective masks according to the second category of medical equipment management.

[Mandatory standard] "GB 19083-2003 medical protective masks technical requirements"

【Main performance】 Based on "GB 19083-2003 technical requirements of medical protective masks," excerpts the main technical requirements are as follows:

4.1 Basic dimensions of the mask

A) rectangular mask after the commencement of the central part of the size: length of not less than 17cm, width of not less than 17cm;

B) Adhesive type masks Dimensions: diameter of not less than 14cm, longitudinal diameter of not less than 14cm.

4.2 Appearance

A) the surface of the mask must not have holes, stains;

B) The mask should not have an exhalation valve.

4.3 nose clip

A) The mask must be provided with a nose clip;

B) The nose clip is made of a pliable plastic material and is not less than 8.5 cm in length.

4.4 mask with

A) Mask tape should be easy to adjust.

B) There should be sufficient strength to secure the mask position. The breaking strength of the connection point between each mask band and the mask body shall be not less than 10N.

4.5 filtration efficiency

Particle filter efficiency of filter masks should not be less than 95%.

4.6 Airflow resistance

In the case of a gas flow rate of 85 L / min, the suction resistance of the mask must not exceed 343.2 Pa (35 mm H2O).

4.7 Synthesis of blood through the barrier properties

The synthetic blood was sprayed at a pressure of 10.7 kPa (80 mmHg) into the mask sample, and the inside of the mask should not penetrate.

4.8 Surface resistance to moisture

Mouth water level should not be less than GB3 GB / T4745 in the provisions.

4.9 Sterilization and sterilization

A) Face masks identified as sterile shall meet the requirements of 4.3.2 of GB 15980.

B) The mask identified as the sterilization stage shall comply with the requirements of 4.3.2 of GB 15980.

4.10 Ethylene oxide residual

The residual amount of ethylene oxide in the masks with ethylene oxide sterilization should not exceed 10 μg / g.

[Regulatory requirements] production, operation and use of units and regulatory authorities should be based on "medical device supervision and management regulations", "one-time use of sterile medical devices supervision and management approach" and other relevant laws and regulations in accordance with the second category of medical equipment for medical protective masks . Production, operation and use of units pay special attention to the following aspects: 1, there should be "medical device manufacturing enterprise license" and "medical device product registration certificate" and product certification, and in accordance with the prescribed period of preservation of valid documents; 3, there should be unqualified product handling system, such as the validity period shall not be stored in non-conforming product areas, shall not be used for clinical purposes. 4, the Treasury into (a) deposit account should be consistent with the actual situation.

[Information] selected on the mask armor flow (from "China Medical News" July 7, 2009 A5 version)

At present, there are three types of masks for medical device management: medical protective masks, medical surgical masks and medical care masks (general medical masks), and their related technical requirements and uses are different.

The role of medical protective masks through the wearer respiration to overcome component resistance, filtration of air particles, blocking droplets, blood, body fluids, secretions, masks, filtration efficiency is higher, the implementation of national standards GB19083-2003 "medical protective masks Technical requirements ", the filter level is N95. This is what the market called "N95 masks," which N95 for the media grade, said the level of non-oily filter media filter efficiency of not less than 95%. It is recommended that medical personnel enter or leave the isolation room or use it in close contact with patients with Influenza A (H1N1).

Medical surgical masks are used by clinical medical personnel during invasive procedures to provide protection to treated patients and practitioners who are engaged in invasive procedures to prevent the spread of blood, body fluids and spatters. The effectiveness of this kind of mask should be not less than 95%, and the filtration efficiency of non-oily particles should not be less than 30%, and the medical industry standard YY0469-2004 "Medical surgical masks technical requirements" should be implemented.

Medical care masks and other general medical masks, the relevant technical requirements for the implementation of corporate registration standards, the lack of non-oily particles and bacteria filtration efficiency requirements, or filtration efficiency requirements than medical surgical masks and medical protective masks are low, the protection Role is limited, can be used for medical units or families a one-time health care, but not for invasive surgery in clinical process, the virus or bacteria can not play a complete barrier effect.

Experts point out that the role of medical care masks on the protection of influenza A H1N1 influenza is very limited, it is recommended that medical institutions and consumers in the actual use of the process, to carefully examine the scope of application of product identification, and select the appropriate product according to demand.