Medical Masks

Medical face masks, also known as surgical or procedure masks, protect the wearer’s face - including the mucous membrane areas of the wearer’s nose and mouth - from contact with blood and other body fluids during medical procedures.

REQUIREMENTS

The intended use environment and market country dictate the applicable requirements. The main intended use of medical face masks is to protect patients from infective agents and, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids.

Medical face masks are considered as medical devices and regulated by national medical device regulations. Regulations will define the legal obligations, to ensure that medical face masks provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standards.

Evaluation areas include (but not limited to): 

Registration and approval

Classification designations 

Marking and labeling

Particulate Filtration Efficiency (PFE) Bacterial Filtration Efficiency (BFE) Differential pressure (breathability)

Blood penetration resistance

Flammability Microbial cleanliness

Biocompatibility

Respirators

Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere respirators are designed for the very efficient filtration of airborne particles.

There are many different types and classifications of respirators, which vary depending on the user's facial coverage and the intended hazardous atmosphere.

Commonly known as a filtering facepiece or half mask, respirators are those masks  whose edges are designed to form a seal around the user’s nose and mouth. This tight facial fit is the one primary differences between respirators and surgical masks that are not intended to provide respirator protection.

Examples of these type of respirators include: 

United States and Canada: N95

China: KN95, KP95

EU: FFP2/FFP3

Australia: P2/P3

Brazil: FFP2/FFP3

REQUIREMENTS

The intended use environment and market country dictate the applicable requirements.

Respirators are generally used in commercial environments, with most intended for use in construction and other industrial type jobs that expose workers to dust and small particles. Some respirators are intended for use in a health care setting, when respiratory and fluid resistance is required.

Due to their primary commercial use, respirator regulations are the jurisdiction of the country’s workplace safety agency. Regulations define the legal obligations to ensure that respirators provide the minimum level of protection against intended risks. Specific requirements by classification will be contained within regulation or cited in referenced performance standards.

Evaluation areas include (but not limited to): 

Certification and Approval

Classification Designations

Marking and Labeling

Particle Filtration Efficiency Breathing Resistance Leakage

Flammability