ABNT NBR 15052 Mask for Dental, Medical and Hospital Use - Requirements and Test Methods

The standard “ABNT NBR 15052 Masks for dental, medical and hospital use - Requirements and test methods”, developed by the Brazilian Technical Standards Association (ABNT), describes the manufacturing, design, performance and test methods of masks for dental and hospital use.

This standard is based primarily on the Australian standard AS 4381-2002 Disposable face masks for use in healthcare settings. This standard contains requirements for disposable face masks used in healthcare settings where cross-contamination between healthcare workers and patients must be minimised. The masks are intended for use in the operating theatre and for medical and dental procedures and practices. They do not apply where an additional degree of respiratory protection may be required due to the risk of airborne transmission.

The purpose of this standard is to establish minimum requirements for medical surgical masks used in operating rooms and other areas of healthcare facilities, particularly where it is necessary to keep cross-contamination between healthcare professionals and patients to a minimum. However, this standard does not apply to respirators or respiratory protection equipment covered by the ABNT NBR 13698 standard.

For the purposes of this standard, the following definitions apply:

• Bacterial filtration efficiency refers to the effectiveness of the filtration material in preventing the passage of bacteria.
• Pressure drop (breathing) refers to the air permeability in the mask and is measured by determining the differential pressure.
• Face fit refers to the ability of the mask to adequately cover the nose and mouth area to prevent inhalation and cross-contamination between healthcare workers and patients.
• The lining material refers to the non-woven fabric that contains the filter and consists of an outer layer and an inner layer.
• The filter element is equipment that acts as a barrier.
• Liquid repellency is the ability of the outer casing material and filter element to resist the penetration of liquids in the air.
• The nose clip is a single strip of malleable material that can be easily bent to fit the contour of the wearer's nose.
• Particle filtration efficiency refers to the efficiency of the filter element material in preventing particles from passing through.
• Surgical mask: A single-use protective equipment designed to cover the mouth and nose. It is indicated for surgical or critical procedures and should protect the patient from contaminating agents from the respiratory tract of the healthcare professional and the healthcare professional from contaminating agents from the patient. Masks should also prevent the passage of blood and other body fluids. Surgical masks are classified as high-protection surgical masks (fluid repellent) and respirators.
• The respirator is a personal protective equipment designed to cover the mouth and nose, which aims to protect the user thanks to its high filtering and sealing capacity and should minimize as much as possible the possibility of inhaling defective air, oxygen supply or air contaminated with pathogenic microorganisms.

The mask should be made of fiberglass-free, odorless fabric. The nose clip should be made of a malleable material such as a single strip of aluminum or other suitable material. It should be easily flexed to conform and maintain the contours of the wearer's nose and cheeks.

The mask must contain a mandatory filter element. Fastening to the user's head must be done using straps or elastic bands. The straps must be fixed to the horizontal or vertical edges of the mask, without holes or seams, with a minimum length of 800 mm. The nose clip, with a minimum length of 130 mm, must be placed inside the covering material and must not extend beyond the mask material.

The mask must cover the wearer's nose and mouth and fit properly on the face. The body dimensions of the surgical mask are shown in the figure given in the standard.

When tested in accordance with the standard annex (Annex A), the particle filtration efficiency of a surgical mask is evaluated as follows:

• Approved if particle filtering efficiency is above 98 percent
• If particle filtering efficiency is below 98 percent, it is rejected.

When tested in accordance with the standard annex (Annex B), the bacterial filtration efficiency of a surgical mask is evaluated as follows:

• Approved if bacterial filtration efficiency is above 95 percent
• Rejected if bacterial filtration efficiency is below 95 percent

When tested in accordance with the standard annex (Annex C), differential pressure (breathing) efficiency is evaluated as:

• Approved if differential pressure (breathing) efficiency is above 4mmH2O
• Rejected if differential pressure (breathing) efficiency is below 4mmH2O

When tested in accordance with the standard annex (Annex D), the strength of surgical mask fasteners is evaluated as follows:

• Approved if the strength of the fasteners is above 11,3N
• If the strength of the fasteners is below 11,3N, it is rejected.

When tested in accordance with the ABNT NBR 14673 standard, the surgical mask must provide a non-irritating result.

Among the numerous tests, measurements, analyses and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “ABNT NBR 15052 Masks for dental, medical and hospital use - Requirements and test methods” standard with its trained and expert staff and advanced technological equipment.