跳至主要内容

KMNPack Participates in The Development of Group Standards For Protective Masks

 KMNPack Participates In the Development Of Group Standards For Protective Masks

  • The structure and scope of the standard
This Standard specifies the terms and definitions, requirements, test methods, inspection rules and classification, labeling, packaging, transportation and storage of daily protective masks. This standard is applicable to non-woven cloth or fabric as raw materials, used in daily life to filter dust, pollen, catkins, bacterial particles and barriers to nasal or oral exhalation or spray pollutants such as respirators.

This standard does not apply to respiratory protective equipment for special industries such as anoxic environment, underwater operation, escape, fire fighting, medical and industrial use. This standard does not apply to mask products for infants and young children under 36 months of age.
  • Discussion on main technical indexes, parameters and test verification
  1. Terms and definitions
This section stipulates the terms and definitions of particulate filtration efficiency, bacterial filtration efficiency, masks for children and masks for the elderly.
 
Respirators for children and respirators for the elderly are characteristic of this Standard. This section defines the two respirators.
  1. Classification and specification 
According to the structure type, it can be divided into planar masks and folded masks. According to the age of the wearer, masks are divided into adult masks, children masks and elderly masks. According to the product filtration level, it is divided into level 1, level 2 and level 3; According to the size of the mask, the size is divided into large, medium and small.
 
This section specifies the specifications of masks for civilian use, which are classified according to the age of the wearer, filtration efficiency, size and so on.
  1.  Requirements
  1. Basic requirements
Meet the basic requirements of GB/T 32610-5.1 2016.
  1. Appearance, dimension deviation and nose clip
The appearance of the mask should be clean and in good shape, and the surface should not be damaged or stained. Nose clips should be made of plastic material. After wearing the mask, it should cover the wearer's mouth, nose and jaw. Should conform to the design size, the maximum deviation should not exceed ±5%. The folding ratio of planar disposable mask is not less than 50%.
  1. Internal quality
This section specifies the technical requirements for the length of the nose clip, the breaking strength at the junction between the mask belt and the mask body, ventilation resistance, pH value, formaldehyde content, decompenable carcinogenic aromatic amine dye, color fastness to friction, color fastness to saliva, and residual amount of ethylene oxide.
  1. Microbial indexes
This part stipulates the technical requirements for the total number of coliforms, pathogenic suppurative bacteria, fungal colonies and bacterial colonies, among which the coliforms and pathogenic suppurative bacteria shall not be detected.
  1. Filtering level
The filtration level is divided into first, second and third levels. The corresponding indexes of each level are: bacterial filtration efficiency is 95%, 95% and 99% respectively; particulate filtration efficiency (non-oily) is 50%, 85% and 95% respectively.
  1. Test methods
Appearance: 10 samples were randomly selected for testing. Visual inspection, fluorescent lamp illumination is not less than 400 LX.
 
Structure and size: 10 samples were randomly selected for testing. Wear the mask and measure the length and width of the mask with a general or special measuring tool with an accuracy of 0.1cm.
 
Nose clip: 3 samples were randomly selected for the test, the material of the nose clip was checked, and the hand was tried bending. The nose clip was taken out, and the length of the nose clip was measured with a general or special measuring tool, with an accuracy of 0.1cm.
 
The filtration efficiency of bacteria, the breaking strength at the connection between the mask band and the mask body, ventilation resistance, pH value, formaldehyde content, carcinogenic aromatic amine dyes that can be decomposed, color fastness to friction and residual ethylene oxide shall be implemented according to the provisions of GB/T 32610-2016.
  1. Inspection rules
According to the delivery batch number of the same variety, the same specification (model) of the products as the inspection batch. Randomly select a corresponding number of samples from each inspection batch according to the test requirements. Delivery inspection items include appearance quality, structure size, nose clip and mask band.
  1. Identifying
The minimum package of masks shall be clearly marked in Chinese and shall include at least the following information:
 
Product name, main raw materials, specifications and sizes, production date, manufacturer's name, production address and date, implementation standards, storage conditions.
  1. Packaging, storage and transportation
Masks should be packaged to prevent mechanical damage and contamination prior to use. The outer packing shall not be damaged in transportation to prevent rain and sunshine. Storage shall be carried out in accordance with the storage conditions specified in the label.

评论

此博客中的热门博文

Reference Standard For Seal Verification of Sterilization Pouches For Medical Devices

With the increasing demand for  sterilization pouches  of medical devices, quality and safety inspection have become more and more stringent. sterilization pouches of medical devices (blister box +  tyvek roll  material,  sterilization paper bag , etc.) as a form of packaging directly in contact with the device and used to block microorganisms. No matter what form of packaging, it has two characteristics, which can meet the sterilization operation and remain sterile until the transportation conditions are used. Therefore, relevant departments began to focus on the review requirements of sterile packaging and make specific requirements for its performance and quality.   As we all know, GB/ t19633-2005 "packaging of ultimately sterilized medical devices" is one of the authoritative standards in the current sterile packaging standards. It is equivalent to iso11607-2003 "packaging of ultimately sterilized medical devices". Clarify the basic performance requirements of s

What is Self Seal Sterilization Pouches

  self seal sterilization pouches  is carried out in hospitals and medical or surgical sterilization manufacturing plants. Most packaging must be sterile when delivered to the end user. Medical self seal sterilization pouches provides protective envelopes for sterilization to protect against sterilization during disinfection, transportation, storage and delivery to the final home. Medical self seal sterilization pouches can assemble and secure several sterilization items required for a given surgical procedure and be ready for operation.   The term "sterilization" covers a wide range of products. A cotton ball, a cotton swab, and a tongue spatula are examples of "treatable products." Use them once and throw them away." Use once is not a synonym for cheap. Some very expensive sterilizations, such as dialysis filters, are themselves too fragile to be cleaned and reused after sterilization. To save costs, reuse is desirable. Most medical sterilization, such as sci

If You Think Your Pouch is Just a Pouch, Wait Until You Read This

  Do you know what self sealing sterilization pouches are? If not, then read on to learn more about these amazing products. A self-sealing sterilization pouch is a bag that can be sealed and opened with one hand and contains an atmosphere that will destroy bacteria and other microorganisms in the bag's contents.   Self seal sterilization pouches   have been used for decades in hospitals worldwide because they offer excellent protection against contamination of medical instruments, surgical equipment, or pharmaceuticals during transport or storage. When self sealing sterilization pouches are used to package medical devices or pharmaceuticals, the self seal sterilization pouch provides a barrier that protects these products against moisture and contamination during shipping. This helps ensure that when your customers use them in their procedures, they will be safe for patient care. What do you truly understand about the sterilization pouches you use? What should you be aware of? What