Product Standards

Q:How are face masks (respirators) certified?

A: NIOSH air filtration rating refers to the classification of filtration in the United States given by the National Institute for Occupational Safety and Health (NIOSH) during the certification and approval process for respiratory protective devices….These classifications only refer to the filtration of particles/aerosols and do not refer to the air-purifying respirator's ability to remove chemical gasses and vapors from air which is regulated under 42 CFR 84 Subpart L.

  • N for Not resistant to oil. Used when oil particulates are not present.

  • R for Resistant to oil. Used when oil particulates are present and the filter is disposed of after one shift.

  • P for oil Proof. Used when oil particulates are present and the filter is re-used for more than one shift.

NIOSH Particulate Respirator Class Minimum Efficiency Levels

Since filters are tested against the most penetrating particle size of 0.3 μm an APR with a P-100 classification would be 99.97% efficient at removing particles of this size.

 

 The "N" refers to the American standard, whereas "KN" is the Chinese standard GB: 2626-2006, and the masks produced according to these two standards have exactly the same level of protection.

Q: How are surgical gowns certified?

A: American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. 

The ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection, and Level 4 being the highest level of protection. 

Q: What is ASTM?

A: ASTM stands for American Society of Testing Materials. Its main task is to formulate characteristics and performance standards, test methods and procedure standards in the fields of materials, products, systems, and services to promote the development and promotion of relevant knowledge.

Q:What is the EN standard?

A:European Standards (ENs) are documents that have been ratified by one of the three European Standardization Organizations (ESOs), CEN, CENELEC or ETSI; recognized as competent in the area of voluntary technical standardization as for the EU Regulation 1025/2012.

An EN (European Standard) “carries with it the obligation to be implemented at national level by being given the status of a national standard and by withdrawal of any conflicting national standard". Therefore, a European Standard (EN) automatically becomes a national standard in each of the 34 CEN-CENELEC member countries.

Standards are voluntary which means that there is no automatic legal obligation to apply them. However, laws and regulations may refer to standards and even make compliance with them compulsory

 

For example European standard EN 149 defines the following classes of “filtering half masks” (also called “filtering face pieces”), that is respirators that are entirely or substantially constructed of filtering material.

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