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Quality Standard of Surgical Gown And Surgical Drape in Healthcare Facilities

Feb. 22, 2022

During surgery, medical staff are easily exposed to patients' blood and body fluids and exposed to various blood-borne pathogenic factors. Surgical gown and surgical drapes are used to maintain a sterile environment and protect patients and medical staff from contamination, and their quality should be sufficient to enable the product to function in the environment intended for exposure. In this paper, the quality standards of protective equipment are associated with clinical selection, and the quality standards for each performance to meet clinical requirements are compared and analyzed, which can be used as a reference for the quality indicators of clinical selection of isolation gown and surgical drape and can also be used as the basis for manufacturers to select production indicators.


Standard choice

Select specifications for selection and quality standards of surgical gown and coverings, including AORN guidelines for selection of surgical gown and surgical drapes, AAMI Standards for surgical gown barrier action, EN 13795 standards for surgical gown and surgical drapes, etc

T fall for According to AORN's guidelines, "surgeon gown and medial drapes should be low-slung." Both the STANDARDS of the United States and the European Union have relevant regulations on flocculation, but the detection methods and standards are different. Flocculation particles are scattered in the environment, and bacteria will adhere to them. The bacteria-carrying flocs can colonize surgical wounds, causing the body to react to foreign bodies and causing infections.


Flame retardant requirement

According to AORN guidelines, "Surgical gowns and surgical drapes should be flammability resistant," and the selection of gowns and drapes should be consistent with acceptable flammability standards to provide the safest environment for patients and healthcare personnel. The standards of the United States all involve the flame retardant index, but the standards of the European Union do not. Surgical gown and surgical sheet materials may be flammable. Special care should be taken when exposed to light and heat sources, electronic surgical equipment, lasers and other energy devices.


Comfort requirements

According to AORN's guidelines, "surgical gowns and surgical drapes should be comfortable and maintain the wearer's body temperature." Gowns and drapes should be free of toxic substances and allergens. Surgical gowns should also be flexible enough for medical staff. AAM I and EN 13795 have no relevant indicators and standards. International standards related to comfort include :(1) cup crush energy test; (2) easy to wear; (3) Can maintain the wearer's body temperature (thermal resistance) ASTM D 1518; (4) Good air permeability (air penetration test ISO 9237)


Barrier capacity requirement

Surgical gown materials should be selected based on the level of exposure to blood and body fluids the user is likely to face. In short operations where there is little exposure of blood and body fluids, surgical gowns with minimal protective properties are acceptable. If the operation is long and complicated and the exposure of blood-borne pathogenic factors increases, surgical gowns with stronger protective properties should be selected. The AAMI barrier capability standard is different from EN 13795. The AAMI barrier capability standard focuses on resistance to liquid penetration, including impact penetration test and hydrostatic test. EN 13795 covers resistance to microbial and liquid penetration by hydrostatic and bacterial penetration tests. EN 13795 requires a relatively strict hydrostatic pressure of ≥ 100 cmH2O in key areas of stiffened gowns; Grade 3 of the AAMI standard specifies ≥ 50 cmH2O.


Abrasion resistance and tensile resistance requirements

Incomplete or easily torn gowns allow passage of microorganisms, particles, and fluids between sterile and germy areas, exposing patients to exogenous organisms and health care workers to blood-borne pathogenic agents. It is necessary to ensure the wear resistance and tensile resistance of the surgical gown whether it is used repeatedly or once. The AAMI standard and EN 13795 have requirements for wear resistance and elongation. According to AORN guidelines, surgical gowns and drapes are designed to maintain their integrity and durability, including tear, puncture and abrasion resistance. The standards of the United States and the European Union have relevant provisions on tensile strength and bursting strength, but the test methods of the two standards are different. EN 13795 uses ISO 13938-1 and ISO 9073-3 for bursting strength and tensile strength, while ASTM D is used for AAMI's abrasion resistance indicators.


According to the above quality standards and guidelines, surgical staff and purchasing staff of the hospital can choose appropriate surgical gowns and coverings to protect medical staff from contamination by various risk factors during surgery and protect patients from contamination by medical staff


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