Interpretation Of The National Standard For Technical Specifications For Child Masks

I. task sources

According to the document No. 68 issued by the National Standard Committee [2018], the National Standardization Management Committee has issued the notice of the national standard for the technical specification for children's daily protective masks. The plan number is 20183033-T-608. In early 2020, in conjunction with the "new crown pneumonia" epidemic prevention and control situation, after communicating with the state authorities, the standard name was changed to "child mask technical specification", covering two types of sanitary and protective masks.

This standard is put forward by the China Federation of textile industry, and the technical committee of the national textile Standardization Technical Committee is affiliated with the technical committee of industrial textiles. On the basis of previous projects, research and standard research, China's Industrial Textiles Association has combined with the existing industrial situation, and jointly with Beijing Institute of labor protection science, Beijing medical device inspection institute, China Standardization Research Institute, children's Hospital Affiliated to Capital Institute of Pediatrics, Guangzhou inspection and testing certification group, Guangzhou customs technology center and Donghua University. And masks and masks, such as backbone enterprises and other scientific research institutes, have organized many experts, such as personal protection, medical and health, ergonomics, textile materials, testing and so on, to do a lot of research on the physiological characteristics of head and face, respiratory system and other physiological characteristics of children of different ages. A large number of data collection, comparative analysis and design of mask materials, structures and properties have been carried out. Indicators and testing methods for children's mask.

Two, the basis and significance of demand

With the progress of society, people pay more and more attention to their own health, including respiratory protection in air pollution environment, self protection against cross infection during medical treatment, self protection in epidemic diseases, and pollen allergy prevention. Mask as a simple, convenient and effective protective product, has the function of blocking the spread of pathogens and preventing inhalation of fine particles, and so on. Important means of self health. The GB/T 32610 - 2016 "daily protective mask technology specification" released in 2016 solves the problem of adult civilian respirators without labels, but it does not apply to children's respirators. Children are in the period of growth and development, various organs are not mature, and there are many kinds of children's masks, the quality is not good, the market supervision has no standard to follow. This has aroused people's concern. The implementation standard of child masks has become a hot issue.

At present, the national standards of respirators in China are divided into three categories: civil, industrial protection, medical and health care: GB/T 32610 - 2016, "daily protective mask technology specification", mainly for the general population to deal with air pollution; GB 2626 - 2006 respirator, self priming filter particulate respirator, is mainly applied to the workplace of labor; GB 19083 - 2010 technical requirements for medical respirators, YY 0469 - 2011 surgical mask and YY/T 0969 - 2013 disposable medical masks, which are mainly applied to the medical field. The above three criteria do not apply to children's respirators.

In Europe and the United States, because of the different concept of wearing, all mask standards are for industrial protection or medical protection, and there is no standard for respirators and respirators. In Japan, masks are divided into 3 types: "medical mask", "industrial mask" and "family mask". Among them, the "family mask", also known as the civil respirator, is for the purpose of preventing pollen, cold, moisture and so on. The masks used daily are divided into two kinds: "gauze type" and "non-woven fabric type", and there is no protective performance requirement. There are no special classifications and standards for children's masks in Japan. Children's masks and adult masks are used as household masks in everyday environments. The Japan Federation of health materials industry (JHPIA) has set the "health and safety independent benchmark" and "advertising independent benchmark" for household masks. The "health and safety independent benchmark" requirement is relatively simple, only without color change, no odor, formaldehyde, aromatic amine requirements. If there are antibacterial properties, implement the "antibacterial independent benchmark"; other special processing, such as deodorization, odor control, anti virus, etc., will meet the quality benchmarks set by the enterprise and conduct safety assessment on its own. Japan is the most common country for children to wear masks. Children's masks are also classified very well, but they are mainly pollen, antibacterial and odor resistant. They are similar to our sanitary masks with barrier masks. There is no standard for children's masks.

In early 2020, a new crown pneumonia outbreak occurred. Masks became the necessary protective equipment for the epidemic situation. With the demand for rehabilitation, going out and seeking medical treatment, children's masks need to consider more factors. Therefore, the standard of children's daily respirator technical specification has not only entered the accelerated mode, but also set the standard positioning, framework, index system and so on. Great adjustments have been made. According to the mask function and the use scenarios, the children's respirators are divided into two categories: child protective masks and child hygiene masks. The respirator has higher requirements on the tightness and protective effect of respirators, and is mainly suitable for children to wear when they are exposed to high pollution or under high risk conditions. Children's sanitary masks are barrier masks, which require high barrier performance for respirator materials, and are mainly suitable for children to wear in daily environment. In this standard, the two kinds of child masks have better complementary functions and scenes, which can basically meet the needs of children in different scenarios, provide reference for parents to choose suitable respirators for children, provide standard support and direction guidance for enterprise production and research, provide basis for market supervision departments, protect children's physical and mental health, and standardize the industry. Order is conducive to protecting the interests of consumers. Therefore, the issuance and implementation of this standard is of great significance.

Three, standard characteristics

This standard pays close attention to the interests of the public and the public. Combined with the characteristics of children's use behavior and the particularity of their growth and development, the basic requirements, appearance quality requirements and 19 main technical indicators are clearly defined. The basic requirements, appearance quality and testing methods of respirators for children aged 6 to 14 are stipulated.

From the technical content, this standard has the characteristics of "two types of two small two docking". The "two category", that is, to fully consider the existing market of children mask products and the practical needs of children's classification and selection of respirators, and standardize the two categories of child protective masks and child hygiene masks.

"Two small", that is, considering that children are still in the stage of physical growth and development, the head and face size and respiratory system are smaller than adults. It reduces the feeling of suffocation when children wear masks, improves the quality requirements of products, and puts forward higher requirements for raw materials selection and product structure design.

"Two docking", that is, the standard filtration performance is linked to the existing domestic and foreign mask standard system, and the particle filtration efficiency of the respirator is not less than 95%, which is in line with the current industrial respirator standard (GB 2626) and the medical respirator standard (GB 19083) connection; children's respirator filtration efficiency of particulate matter is not less than 90%, at the same time meet the requirements of bacterial filtration efficiency, and medical surgical masks (YY 0469) and disposable medical masks (YY/T 0969) convergence. These indicators are not only in keeping with the existing national and industrial standards of masks, but also matched with the guidelines for the use of masks issued by the health and Health Committee in January 2020 and February.

Four, the main content of the standard setting

This standard is suitable for children aged 6 to 14 years old to filter particulates in air, and to shield masks, such as microbes, pollen and droplets. The children's respirators are divided into child protective masks and child hygiene masks. According to the characteristics of children's physical development and liveliness, taking safety as the premise, taking protection and comfort as the goal, and closely surrounding the protective function and wearing safety of the respirator, the corresponding index requirements are set up, including material safety, design safety, wearing safety and necessary protective functions. Generally speaking, when the technology level is the same, the higher the protective performance, the lower the comfort will be. Because of the protection of children's respiratory system, under the current technology level, respirator resistance and ventilation pressure of children's respirators have set a relatively low index value. The technical specifications and testing methods of this standard refer to the relevant standards, and are in line with the relevant laws, regulations, regulations and relevant standards.

Five, main technical indicators and testing methods

1. basic requirements

The basic requirements are the safety requirements for the materials used in masks, the materials for masks and the design of masks, which reflects the safety concerns of consumers wearing masks.

(1) the respirator should be able to cover the mouth, nose and jaws safely and firmly without any peculiar smell. This clause is the basic requirement for mask design. Under the premise of aesthetics, mask designers need to study the facial characteristics of children, and ensure that the respirator has good adhesion with children's face, laying the foundation for the protection function.

(2) the raw materials for masks should not be recycled. No known materials that can cause skin irritation or other adverse reactions should be used. No chlorine bleaching should be allowed. Other residues should be met. The material should ensure that there is no damage or deformation in the normal service life of the respirator.

It needs to be explained that the mask supplier should be able to prove that the material meets the requirements. It can be proved that the textile materials used in the respirator meet the requirements of 4.2A in GB 31701 - 2015 by means of inspection or inspection reports.

This clause is the requirement for the production of child masks and the most basic requirement for the safety performance of children's respirators. Special attention should be paid to the heavy metal content requirements of 4.2A in GB 31701 - 2015. However, this standard does not make specific requirements for the production of children's mask materials. It is intended to encourage enterprises to use new materials that meet the relevant requirements for children's masks, and continuously improve the quality and protective performance of children's masks.

(3) masks should not be worn with a strap, and adjustable respirator bands should be used. This clause is the requirement for the use of masks for children's masks. This requirement is raised in view of the lively and dynamic growth of children.

(4) masks should be easy to wear and remove, and there is no obvious pressure or tenderness during the wearing process. This clause is a basic requirement for mask design from the perspective of safety and comfort.

(5) a mask with a nose clip. The nose clip should be made of plastic material. This clause is aimed at improving the requirements of the mask's tightness. After the nose clip is pressed, the mask and face can be strengthened to enhance the protective performance.

(6) respirators with respirators should not fall off during normal use. This provision is to consider the poor self-care ability of children, especially the basic requirements for children respirators with breathing valves. Remind children mask manufacturers need to pay attention to the firmness of breathing valve fittings.

2. appearance quality requirements

(1) the inner material that the mask should directly contact with the skin should not be printed or dyed. Because the mask is covered on the mouth and nose, the skin of the child is tender and the respiratory system is in its developmental stage, and the inner materials that require direct contact between the mask and the skin should not be dyed. Children like all kinds of beautiful color patterns, so this requirement does not apply to the outer mask, whether the outer mask of the mask is stained and whether there are various designs are designed by the enterprise itself, and the standard does not require. However, if it is dyed, the color fastness to dry friction should be tested.

(2) there should be no exposed metal in the mask. There should be no surface damage, oil stain, deformation and other obvious defects. The mask should not be exposed to metal. The "sharpness of the tip and edge" is a complementary expression of the same characteristics, and avoids the special requirements of metal damage to children.

3. internal quality requirements

(1) migratory fluorescent whitening agents. Mobile fluorescent whitening agent is a fluorescent dye. Fluorescent brighteners can improve the appearance of the material. At present, the knowledge about the hazards of fluorescent whitening agents is not uniform. There is no authoritative data about the toxicity of fluorescent whitening agents. In order to prevent possible harm to children caused by fluorescent whitening agents, this standard provides that no fluorescent brighteners can be detected in children's masks.

(2) ethylene oxide residues. Ethylene oxide is a toxic carcinogen and is widely used for sterilization. Most mask manufacturers use ethylene oxide to kill microorganisms. The mask needs to be analyzed for some time after ethylene oxide sterilization. During this process, ethylene oxide basically evaporated, leaving only traces of residue. But it is corrosive to the eyes and respiratory tract. The state has control requirements for residues. This standard is for the protection of children's health. Considering the testing methods and testing equipment, the residue of ethylene oxide treated by ethylene oxide is less than 2 g/g, far lower than the value of medical mask less than 10 g/g.

(3) nose clip length. Children's masks are of different appearance and styles. In order to strengthen the bonding with the face, some enterprises have adopted the design of the nose instead of using the nose clip to achieve the face fit with the structure. However, most enterprises use the nose clip, and the minimum length of the nose clip is given according to the children's facial size characteristics. This standard encourages enterprises to personalize their designs according to their children's characteristics, and to provide consumers with more fashionable masks while meeting the needs of obstructing.

(4) folding resistance of nose clip. The folding resistance of nose clip is based on the characteristics of children's movement. The index setting is referenced to GB 6675.2 "toy safety second parts: mechanical and physical properties". The folding resistance of nasal clip is regulated, and the potential harm to children is reduced. At the same time, the characteristics of children's behavior, the convenience and maneuverability of examination are taken into account, and the folding test method is adopted. It is required to fold 20 times without breaking.

(5) the mask band is connected with the mask body to break the strength. The connection strength of the mask and the mask is one of the factors that ensure the wearing of the mask. According to the different classifications of children's masks, this standard specifies the breaking strength of the mask and the mask body similar to the wearing state.

(6) respiratory resistance. Respiratory resistance is an assessment index for children's respirators. It is used to assess the comfort of children wearing respirators. During the index setting of respiratory resistance, the standard establishment group mainly investigated the respiratory process and respiratory resistance of children. Children are at the stage of growth and development. From 6 to 14 years of age, with the increase of age, height and weight, lung capacity increases, airway diameter increases, respiratory resistance gradually decreases, and tends to adult level. In order to avoid potential harm to children's respiratory system after wearing masks, high level and low resistance filter materials should be used for children's respirators. Based on the large number of testing data of children's respirators and filter materials, the respiratory resistance is less than 45Pa, which is better than the current standard of respirator. Production enterprises need to select efficient and low resistance filter materials for children's respirators.

(7) protective effect. Protective effect is a key index for the protective performance of child respirator. The index values represent the level of protection for children's masks. This standard refers to GB/T 32610 "daily protective mask technical specification" in the highest protection grade A as a child mask respirator effect requirements, the protective effect of not less than 90%.

(8) particulate matter filtration efficiency. Particulate matter is suspended in the atmosphere of different sizes, including dust, droplets, aerosols and so on. Mask filter material can play the function of filtering these particles. Particulate matter filtration efficiency is an international evaluation index for respiratory filter materials. Combined with the different application scenarios of the two types of respirators and the technical level of melted filter media, this standard specifies the particle filtration efficiency of child respirators and child hygiene masks. Among them, the respirator respirator particulate matter filtration efficiency (refer to GB/T 32610 "daily protective mask technical specification") requirements of more than 95%, children's respirator particulate matter filtration efficiency (refer to YY 0469 to 2011 "medical surgical mask") requirements of more than 90%.

(9) bacterial filtration efficiency. Bacteria are a single celled organism that invades the local tissue and systemic inflammatory reaction that may cause the human body. As a respirator, it is a basic protective function for bacterial filtration. The index of bacterial filtration efficiency of this standard refers to YY 0469 - 2011 related indicators of medical surgical mask, which stipulates that the efficiency of bacterial filtration is not less than 95%, so as to meet the requirements of bacteria protection for ordinary consumers after wearing masks.

(10) ventilation resistance. This item is a comfort index for children's health masks. According to the current technical level of domestic respirator filter, taking into account the physiological condition of children, the ventilation resistance of children's mask materials is set to be less than 30Pa. This index is better than the other adult mask values.

(11) flame retardancy. Children's ability to deal with emergencies is poor. Taking into account the possible damage to children caused by a sudden fire, the flame-retardant properties of children's respirators are specified. Indicators refer to YY 0469 - 2011 medical surgical masks, and the time of burning is not greater than 5S after leaving the flame.

(12) sharp edges and sharp edges. Children's ability to distinguish dangerous is obviously lower than that of adults. Therefore, children's products need to avoid the possibility of injury to children as far as possible. This standard clause is a requirement for children's mask design and accessories, and manufacturers need special attention.

(13) respiratory valve cover fastness. This design ensures that the normal wear and mask functions are effectively set up, stipulates that the valve cover should not be slipped, broken or deformed. The method is implemented in accordance with GB/T 32610. Respirators are not recommended when used for epidemic protection.

(14) microbial indicators. Microorganism is invisible or invisible to the naked eye, but it is closely related to human life. Microbiological indicators are the basic requirements of hygienic products. Referring to GB 15979 - 2002 hygienic standard for disposable sanitary products, the standard set the index value for the common microorganism.

(15) color fastness (dry friction), formaldehyde content, pH value, and decomposable carcinogenic aromatic amine dyes. The above indicators are the basic requirements of textile materials. The index is set according to the relevant provisions of GB 18401 national basic safety technical specifications for textile products, and formaldehyde content and pH value are set according to type A (infant Textiles).

4. test method

(1) the testing method in this standard refers to the relevant contents of current national standards and industry standards. It has strong operability and high market acceptance. It can meet the test requirements of this standard. Relevant enterprises and testing institutions can be used quickly.

(2) the protective effect was simulated by simulated head and respiratory simulator (artificial lung). Simulation of head movement can simulate children's speaking, lowering their heads and shaking their heads in order to get closer to the actual wearing condition.

Six, warning words

Respirators are sanitary and protective products, but because they are used to cover the mouth and nose, it is very important to wear them properly. Especially for children whose mental status is still developing, the necessary education is more important. In the standard, it is clear that children's masks manufacturing enterprises should print warning words on the packaging to remind parents (adults) children to pay attention to the wearing of masks.

A) children with dyspnea are not advised to wear masks. If they are required to wear them, they should follow the doctor's advice or wear other suitable respirators.

B) when using, masks and other packaging materials must be removed from the mask.

C) children should wear masks under adult care. Caregivers should pay attention to observing and educating children to wear masks correctly. Children should not be noisy or moderate or medium intensity during wearing masks, and should not disassemble respiratory and respiratory components. If there are symptoms such as respiratory discomfort and skin allergy during wearing, remove the mask timely and consult the doctor if necessary.

D) masks should be kept dry. Avoid wetting in use and replace them promptly if necessary.

E) mask is not recommended for reuse after washing.

F) masks that are used should not be exchanged with others.

Seven, implementation recommendations

This standard is a newly established standard, which can be used as the technical support and market supervision basis for enterprise production. It is recommended that the production enterprise do the following work:

1. according to the market positioning of children's mask products, choose the types and specifications of respirators.

2. read the standards in detail and understand the standards.

3. select the qualified child mask and use raw materials, and suggest to ask the supplier for the inspection report of the material.

4. make the identification and use instructions clear, clear and traceable.

5. warning words are easy to identify.