Certifications and evaluation needed by the 3 ply surgical mask manufacturer

Infectious agents can be spread in a variety of ways during surgical operations in operating rooms and other medical facilities. The nose and mouth are two of the most common ways for germs to spread. A person discharges little and large volumes of secretions from the mucous membranes through the mouth and nose while breathing, speaking, coughing, or sneezing. These droplets evaporate fast, leaving nuclei floating in mid-air. If the nuclei are small enough, they can move via the air to a vulnerable spot like an open operating wound or sterile equipment, or they can be breathed. As a result, every medical facility purchases surgical masks from a reputable 3 ply surgical mask factory to be sure of its guaranteed protection.

BIS Certification

This accreditation guarantees that the product's quality is preserved at all times. This BIS Certification comes with a plethora of advantages. Here are a few examples:

• Before use, verifies the quality to ensure that it is usable.
  
• Examining the product’s authenticity, safety, and purity.
• Quality assurance.
• Winning consumer trust.
• Implementing an ambitious edge.
• Quality assurance will traverse into more sellouts.

Furthermore, the government has mandated that all producers obtain a BIS licence and ISI-marked masks before shipping to HLL or any other government entity.

Evaluation of surgical mask in Europe

Surgical masks must be CE-marked and meet the standards of EN 14683: Medical face masks - Requirements and test procedures in Europe.

 

Surgical masks are defined as medical devices that cover the mouth, nose, and chin to provide a barrier that prevents infectious agents from spreading from hospital workers to patients.

In terms of performance, the mask is examined as a finished product and must meet a variety of requirements.

The results of the following tests are used to categorise the masks.:

• bacterial filtration efficiency (BFE)
• breathability (delta P)
• splash resistance (synthetic blood)
• microbial cleanliness
• biocompatibility

Because surgical masks are class I medical devices, the manufacturer must conduct a risk analysis and, if necessary, further testing to comply with the European Medical Device Regulation 2017/745.

There are no specifications regarding barriers against inert particles.

Evaluation of face masks in the USA

Surgical masks are classified as medical device class 2 by the FDA, which governs all medical equipment in the United States. The FDA has created rules that manufacturers must follow to obtain a licence to sell certain medical devices on the market. Surgical masks, operations, isolation, dental interventions, and laser treatments all fall within these guidelines. Furthermore, the FDA strongly advises that a 3 ply surgical mask factory explicitly states the product's intended usage on the label. The FDA also requires that filtering efficiency be measured for inert particles (latex) and that fire tests be performed.

 

The performances of the materials composing the 3ply surgical mask are evaluated by five tests:

• bacterial filtration efficiency
• breathability (delta P)
• splash resistance
• particle filtration efficiency
• fire test According to the results, the masks are classified into three levels.