Standards for Surgical Respirators and Masks: Relevance for Protecting Healthcare Workers and the Public During Pandemics

Abstract

Abstract National standards for surgical respirators and masks are written and enforced to protect healthcare workers from particles and microorganisms such as Severe Acute Respriatory Syndrome Coronavirus 2 (SARS-CoV-2). In addition to the ability to filter particles (e.g. filtration efficiency, FE), the standards address breathability (e.g. differential pressure), how well the mask seals to a worker’s face (e.g. fit test), the level of protection from a fluid splash, and other factors. Standards used in the USA, European Union (EU), and China were compared with respect to testing methods and certification criteria. Although there are substantial similarities in standards for respirators, such as surgical N95, FFP2, and KN95 filtering facepiece respirators (FFRs), there are differences with respect to who performs that testing and fit-testing requirements that influence certification. There is greater variation in test methods between countries for surgical (USA) or medical (EU and China) masks than for FFRs. Surgical/medical masks can be certified to different levels of protection. The impact of the similarities and differences in testing methods and certification criteria on FFR and mask performance for protecting healthcare workers from SARS-CoV-2 are discussed, as well as the value of a new standard in the EU for testing fabrics for masks used by the public. Health and safety personnel in healthcare settings must understand the differences between standards so that they can select respirators and masks that provide appropriate protection for healthcare workers.