What Standards Do Non Medical Masks Export To Meet? Those Who Want To Export First Check This...
Affected by the global new crown pneumonia epidemic, overseas market demand for domestic masks is increasing. The relevant departments of the state stipulate that no matter what masks are produced, they must comply with the relevant standards of the export areas (countries) before exporting, and they should also meet our quality standards. Otherwise, they can not export.
In April 25th, the Ministry of Commerce, the General Administration of customs and the State Administration of drug supervision and Administration Jointly released The notice on Further Strengthening the quality supervision of the export of epidemic prevention materials requires that the quality supervision of the masks should be strengthened, and the export order of the epidemic prevention materials should be standardized. 。 The law of the PRC on the quality of products stipulates that producers should be responsible for the quality of the products they produce.
To further ensure the quality of non medical masks in Shenzhen, the Shenzhen municipal market supervision authority has organized relevant technical institutions to compile. Guidelines for improving the quality standards of non medical masks in Shenzhen (hereinafter referred to as the "guidelines for work") aims at helping the epidemic prevention enterprises comply with the regulations and promoting the "made in Shenzhen".
Prenatal notice
One
Obtain business qualification
The production and operation of non medical masks must obtain legal business qualifications.
1. obtain business license;
2., there are corresponding business areas, such as production and sales of respirators. 。
Two
Clear implementation standards
Define the implementation criteria for the production of non medical masks.
1. Current status of non medical mask standards
At present, the current implementation standards of non medical masks in China are:
(click the picture to enlarge)
According to the characteristics of their products and the application scenarios of consumers, enterprises can choose suitable and effective product standards or make no less than the corresponding areas. Country Mandatory standards of enterprise standards for production and quality control.
Domestic and foreign standard query platform for mask products:
Https://www.sist.org.cn/xgfyfhbzzl/kzh/gnkzh/
The access policy and control measures query platform for mask products at home and abroad:
Http://www.tbtmap.cn/rdht_ 124/xgfyfhypzr/
2, how to declare corporate standards?
Before the formal production of mask products, it is necessary to declare publicly that the mandatory standards, recommended standards, group standards or enterprise standards that the products perform are encouraged, and encourage them to be disclosed to the public through the standard information platform of Shenzhen.
The disclosure of standard information should meet the following requirements:
(1) The enterprise shall enforce the mandatory standard, recommendation standard, group standard or enterprise standard, and shall disclose the corresponding standard names and standard numbers. ;
(two) If an enterprise implements its own enterprise standard, it should also disclose the corresponding function and performance index of the product and service. You can also choose to publish the full text of the standard.
Shenzhen standard information platform: Http://szbz.sist.org.cn/
Enterprises need strict control in production
(1) strict selection of raw materials
The mask manufacturers can be compiled according to the Guangdong market supervision and Administration Bureau. Guidelines for quality and technical specifications of raw material supply and mask production (link:
To establish and perfect the mechanism of raw and auxiliary materials entering into the factory, which is in line with actual demand, to promote raw and auxiliary materials to meet the procurement requirements and relevant standards from the source, and prevent unqualified raw and auxiliary materials from entering the production process.
(two) strict grasp of production environment
Non medical mask manufacturers can refer to the requirements of GB 15979-2002 "Hygienic standard for disposable sanitary products" for environmental control and manage the production environment.
1, the surrounding areas of the production area should be clean and clean, and there are no breeding grounds for such pests as mosquitoes and flies.
2, the production area should have enough space to meet production needs. The layout must be in line with the production process requirements, separated reasonably, and the diversion of people and goods, and there is no reverse and cross in the product process. Pollution prevention measures and strict operational procedures should be taken for raw materials and finished products to reduce microbial contamination in the production environment. 。
3. Production area Effective dust control, pest control and anti mouse facilities should be provided. Floors, walls and worktops should be smooth, smooth, dust free, easy for dust removal, cleaning and disinfection, and adequate lighting and air disinfection or purification measures. 。
4. Raw materials and finished products should be stacked separately. The raw materials and finished products to be inspected, qualified and unqualified should be stacked and marked clearly. The warehouse should be dry, clean, ventilated, pest control, anti mouse facilities and cushion panels, in line with product preservation conditions.
5, for the production of non sterile mask. In order to control the total number of bacterial colonies below 100cfu, it is recommended to be produced in the 300 thousand class clean room. If it is produced in the ordinary workshop, it is necessary to disinfect the finished respirator. , It is suggested to produce in the cleanroom at level 300 thousand or higher, control microbial contamination and ensure sterilization effect.
(three) strict management of production personnel
Enterprises should strengthen personnel training and professional skills training, with emphasis on:
1. People engaged in production should be trained before and after regular health checks and hygiene knowledge, including production hygiene, personal hygiene, relevant standards and specifications, and those who are qualified can be employed.
2. Strengthen personnel training. The relevant operational skills need to be trained and dedicated to eliminate production lines due to operational errors.
3, collect professional and technical institutions to record and broadcast micro classrooms or documents, dry goods, regularly carry out professional and technical training for personnel, improve the correct understanding of the quality standards of enterprises, and arrange production according to the requirements of quality standards and technical specifications, so as to ensure the quality of products.
(four) strictly control the production process.
Non medical mask production process supervision involves personnel, machinery and equipment, materials, operation methods, operation environment, process self inspection, inspection supervision and so on.
Enterprises should establish and improve the production management mechanism, establish a production process supervision team, and focus on safety, management progress, cost management, management efficiency and quality control. The main responsibilities include production plan execution, production site work discipline, quality control of production process, production site safety production, staff skills training and upgrading, production site personnel organization and deployment, and hygiene. Environmental hygiene management, self inspection and supervision of production process, implementation of process and implementation of quality standards, inspection and supervision.
Establish feedback mechanism, adjust and improve the operation of the production line timely according to the actual production situation, and urge the production department to achieve conformity to the process technology and quality standards in the production process. Recommendation:
1. Compile production process specification and work instruction. Strictly stipulate process parameters and organize production according to qualified parameters.
2, each batch of products should have production records and meet the traceability requirements. Production records should include: product name, specification, type, batch number of raw materials, production batch number or product number, production date, quantity, main equipment, process parameters, operator and so on.
3. Each batch of products should have inspection records and meet the traceability requirements. Identify the inspection status of products in the production process, and prevent the flow of unqualified intermediate products to the next process. 。
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