EN ISO 16975 Respiratory Protective Devices - Selection, Use and Maintenance

The standard “EN ISO 16975 Respiratory protective devices - Selection, use and maintenance”, which is a European standard and subsequently published by the International Organization for Standardization (ISO), consists of the following subsections published under the same title:

• EN ISO 16975-1 Part 1: Establishment and implementation of a respiratory protective device program provides detailed information to assist those responsible for establishing and implementing a respiratory protective device program that meets the performance requirements of the performance standards. However, this standard does not apply solely to respiratory protective devices for underwater use, respiratory protective devices for use in aircraft, or medical life support respirators and resuscitation devices.

The information contained in this standard may be used to assist in the preparation of national or local regulations, but it does not replace national or local regulations.

Failure to properly select, use and maintain respiratory protective devices can result in injury, illness or death.

Respiratory protective devices are at the bottom of the control measures hierarchy and should be used only after an appropriate risk assessment has determined their acceptability. Respiratory protective devices are used to further reduce inhalation exposure to hazardous atmospheres where adequate engineering and administrative controls are not available and such controls are not reasonable.

A respiratory protective device program includes the processes for selecting, using, and maintaining respiratory protective devices to provide adequate protection to the user. It is important to establish a written program before using respiratory protective devices. This program must be understood, as appropriate, by all individuals in the organization.

• EN ISO 16975-2 Part 2: Concise guidance on establishing and implementing a respiratory protective device program provides a concise guide to assist those responsible for establishing and implementing a respiratory protective device program that meets performance requirements. There are specific applications where selecting the appropriate respiratory protective device using this guide is not appropriate. These include:
  • Firefighting: Structural and forest firefighting, hazardous materials and rescue practices;
  • CBRN: Chemical, biological, radiological and nuclear agents
  • Marine: Firefighting or hazardous materials applications on board or offshore
  • Mining: Underground mining or firefighting and rescue applications
  • Escape: General, fire, CBRN, marine and mining.

For more detailed information on specific applications, EN ISO 16975-1 applies. This guide does not apply to the selection of respiratory protective devices against bioaerosols.

Respiratory protective equipment should only be used after all other reasonably practicable control measures have been taken.

To select adequate and appropriate respiratory protective equipment, a risk assessment must first be completed, taking into account the hazardous substances used or manufactured, potential oxygen deficiency, the tasks performed, and the person performing the tasks (i.e., the user). Information such as occupational exposure limits for hazardous substances can be found in their safety data sheets, material safety data sheets, or other published documents.

There are two types of respiratory protection devices:

• Filtering respiratory protective device: This device removes hazardous substances from ambient air (for example, by filtration, adsorption, or chemical reaction) before the wearer can breathe them in. Air is drawn through the filters by the wearer's breathing movements or by a blower unit.
• Supplied breathable gas respiratory protective device: This device provides the wearer with breathable gas from a source independent of the ambient atmosphere, either individually carried (self-contained) or from a remote source.

All respiratory protective devices are classified by protection class (PC1 to PC6), duty cycle class (W1 to W4), and respiratory interface class. Filtering respiratory protective devices are also classified by filter type and class, and supplied breathable gas respiratory protective devices are classified by breathing gas capacity.

Respiratory protective devices are available with various respiratory interfaces. They are categorized based on the area they cover and the fit they provide to the wearer's body. These include mouth only, mouth and nose, face, head, and body. Respiratory interfaces can be either tight-fitting (type T) or loose-fitting (type L). Examples of various respiratory interfaces and respiratory protective device types are included in the EN ISO 16975-1 standard.

• EN ISO 16975-3 Part 3: Fit testing procedures" provides guidance on how to fit-test tight-fitting respiratory protective devices and the appropriate methods to use. Fit testing is only one element of a complete respiratory protective device program. The purpose of fit testing is to evaluate the effectiveness of the seal between the wearer's face and the respiratory interface. A complete respiratory protective device program is defined in EN ISO 16975-1.

This standard specifies the requirements for conducting respiratory protective equipment (RPE) fit testing and includes: qualifications/competence of fit testing operators, specific fit testing procedures, interpretation of fit testing results, and record keeping. Fit testing is not required for respiratory protective equipment intended solely for escape purposes.

Fit testing is an essential part of an effective respiratory protective device program. All occupants using a close-fitting respiratory protective device must undergo an appropriate qualitative fit test or quantitative fit test as described in this standard. Fit testing must be performed by a qualified fit test operator before the first use of the respiratory protective device. Close-fitting respiratory interfaces with face or neck seals will not provide optimal performance if they do not fit properly and therefore must be fit tested on the occupants who will wear the respiratory protective device. All other respiratory interfaces do not require fit testing. A fit test is not required for respiratory protective devices intended for escape use only.

The purpose of a respiratory protective device fit test is to verify that the selected make, model, and size of tight-fitting respiratory protective device adequately fits the wearer. Prior to the fit test, the eligible wearer must receive training on the purpose and procedures of the fit test to achieve the required level of competence. The fit test is a verification that the wearer understands how to properly inspect, put on, and take off a respiratory protective device of a specific make, model, and size, and how to perform a wearer seal check. The wearer undergoing the fit test must be free of hair or jewelry in the sealing surface area of ​​the respiratory interfaces.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the EN ISO 16975 Respiratory Protective Devices - Selection, Use, and Maintenance standard.