clean room garments factory:What material is medical protective clothing made of?

Types of medical protective clothing

At present, there are three kinds of medical personnel protection products used in hospitals: isolation clothes, surgical clothes and medical protective clothes, in addition to head, hand and foot protective articles.

Isolation clothing refers to the clothing worn by medical staff when contacting patients, family members visiting patients and other occasions;

Surgical clothes refer to specially designed clothes worn in the operating room;

Protective clothing refers to the clothing worn by personnel in special areas such as medical first aid, infectious disease area and electromagnetic radiation area.

According to the requirements of different use conditions, the three products should meet different performance requirements.

Among them, the isolation clothing is the first type of medical devices, and the performance requirements are relatively minimum. At present, there is no industry standard or national standard in China.

Surgical clothing and protective clothing are class II medical devices. China has established the performance research method of surgical clothing in YY / T 0506 series standards and the technical requirements of medical disposable protective clothing in GB 19082.

At present, the standard of reusable medical protective clothing has not been established in China. Here we mainly introduce the medical disposable protective clothing that meets the requirements listed in GB 19082, which is also the most needed protective clothing in this epidemic. The product is mainly used by medical personnel who may contact the blood, body fluids, secretions and particulate matter in the air of potentially infectious patients at work.

Material of medical protective clothing

Protective clothing is usually made of composite materials, such as polyester or polypropylene spun nonwovens compounded with breathable microporous film or other nonwovens, spunlaced nonwovens compounded with breathable microporous film, or wood paddles compounded with spunlaced nonwovens. At present, polyethylene flash spinning nonwovens and spun viscose / melt blown / spun viscose (SMS) or spun viscose / melt blown / melt blown / spun viscose (SMMs) composite nonwovens are widely used to composite with microporous films, and are finished with "three rejections and one resistance" (water repellent, blood repellent, alcohol repellent and antistatic).

Nonwovens:

It refers to the sheet, fiber net or floc pad made of oriented or randomly arranged fibers by friction, binding, or bonding, or a combination of these methods, excluding paper, woven fabric, knitted fabric, tufted fabric and wet shrinkage felt products (gb/t 5709--1997 terminology of textiles nonwovens).

To put it simply, it is not interwoven and braided by one yarn, but the fibers are directly bonded together by physical methods. Therefore, nonwovens cannot draw thread ends one by one.

Performance of medical protective clothing

Performance requirements of protective clothing materials, including protection, wearability, safety and hygiene.

In short, protective clothing should not only remove moisture, breathe and wear freely, but also protect medical staff from the infection of viruses, bacteria and other pollutants in the process of diagnosis and treatment, resist the invasion of water, alcohol and blood, but also effectively resist static electricity and even prevent dust from entering.

Specifically:

① The protective property requires liquid barrier function, water permeability of key parts of protective clothing (left and right front, left and right arms and back), and hydrostatic pressure resistance of not less than 1.67kpa; The penetration resistance of synthetic blood shall not be lower than grade 2, that is, synthetic blood shall not penetrate after acting on protective clothing at the pressure of 1.75kpa for 5 minutes; The level of water on the outer side of protective clothing shall not be lower than grade 3. This technical index is to prevent the patient's blood, or the disinfectant, flushing fluid and other liquids during the operation from polluting the medical workers through the protective clothing.

② Protective clothing shall have the performance of preventing the penetration of micro particles, and the filtration efficiency of key parts and joints of protective clothing for non oily particles shall not be less than 70%. This technical index is to prevent the invasion of virus carrying micro particles (such as spitting). In addition, the seams of protective clothing must be sealed to cover the pinholes left during sewing.

③ The wearability requirements of protective clothing include sufficient strength and dimensional stability. During the tensile test, the breaking strength shall not be less than 45N and the elongation at break shall not be less than 30%. This technical index is to ensure the physical properties of clothing and make it not easy to be damaged.

④ In terms of wearing comfort of protective clothing, the moisture permeability of protective clothing materials shall not be less than 2500g / m2 · D. This technical index is to ensure that the wearer's sweating heat is discharged in time.

⑤ The safety and hygiene of protective clothing requires that it is non-toxic, non irritating and anti fungal.

⑥ Protective clothing is disposable, and the economy requires that the cost be reduced as much as possible while ensuring the protective performance.

Relevant standards, regulations and documents of medical protective clothing

We have collected relevant standards, regulatory requirements, documents and data requirements for medical protective clothing.

Guiding principles for technical review of medical protective clothing product registration

YY / T 1499-2016 liquid barrier performance and classification of medical protective clothing

GB/T3923. 1-2013 Textiles - Tensile Properties of fabrics - Part 1: Determination of breaking strength and elongation at break - strip method

GB/T12703. 1-2008 evaluation of electrostatic properties of textiles Part 1: half-life of static voltage

GB/T12704. 1-2009 Textiles - Test methods for moisture permeability of fabrics - Part 1: moisture absorption method

GB/T12704. 2-2009 Textiles - Test methods for moisture permeability of fabrics - Part 2: evaporation method

GB 18278.1-2015 requirements for sterilization confirmation and routine control of medical and health care products - Industrial damp heat sterilization

GB 18279.1 and GB / T 18279.2-2015 validation and routine control of ethylene oxide sterilization for medical devices

GB 18280.1-2015 and GB 18280.2-2015 requirements for sterilization confirmation and routine control of medical and health care products radiation sterilization

GB / T 16886.1-2011 biological evaluation of medical devices Part 1: evaluation and test

GB / T 16886.7-2015 biological evaluation of medical devices Part 7: ethylene oxide sterilization residue

GB / T 16886.10-2005 biological evaluation of medical devices Part 10: stimulation and delayed type hypersensitivity test

GB / T 19633.1, GB / T 19633.2-2015 packaging of final sterilized medical devices

GB / T 14233.1-2008 test methods for medical blood transfusion, infusion and injection equipment Part 1: chemical analysis methods

GB / T 14233.2-2005 test methods for medical blood transfusion, infusion and injection equipment Part 2: biological test methods

Inspection requirements and inspection organization of medical protective clothing

The inspection of medical protective clothing products includes factory inspection and type inspection. The delivery inspection items shall at least include the following items: appearance, structure and size, breaking strength, elongation at break, microbial index and ethylene oxide residue (if ethylene oxide is used for sterilization). Considering the incoming inspection of raw materials and the delivery inspection of medical protective clothing, the enterprise should configure basic inspection instruments, such as dynamometer, micrometer, vernier caliper, ruler, etc. If the microbiological index and ethylene oxide residue are self-test, a microbiological laboratory and corresponding instruments are required.

The type inspection shall be the full performance inspection required by the product technical requirements, and the medical device inspection institute approved by the food and drug administration shall be selected. The State Administration of market supervision has published the list of inspection and testing institutions for medical devices and protective articles with national qualification.

The General Administration of market supervision (CNCA) publishes the list of inspection and testing institutions for medical devices and protective articles with national qualification

Time: February 7, 2020 source: website of the State Administration of market supervision

In order to strengthen the quality and safety supervision of protective equipment, give full play to the technical guarantee role of inspection and testing in epidemic prevention and control, and meet the needs of inspection and testing of protective equipment, the inspection and testing institutions of protective equipment for medical devices that have passed the examination and approval of the national certification and Accreditation Administration Commission and obtained the qualification are hereby published (the specific list is attached). There are 55 such institutions in total, of which 30 furniture has the ability to detect medical disposable protective clothing, 34 furniture has the ability to detect medical protective masks, 28 furniture has the ability to detect medical surgical masks, 24 furniture has the ability to detect disposable medical masks, 34 furniture has the ability to detect disposable sterilized rubber surgical gloves, and 34 furniture has the ability to detect disposable medical rubber inspection gloves.

In addition, there are more than 170 inspection and testing institutions for protective articles that have obtained the qualification of the provincial market supervision department. Units or individuals in need can consult the local market supervision department or relevant inspection and testing institutions.

The epidemic situation is an order, and prevention and control is a responsibility. The inspection and testing institutions should conscientiously implement the major decisions and arrangements of the CPC Central Committee and the State Council on the prevention and control of New Coronavirus infection, and stick to the work posts, open easy access to protective products inspection and testing services, and do well in the inspection and testing of protective products during epidemic prevention and control, so as to provide accurate, fast and high-quality technical support services for consumers and users.