The International Society for Respiratory Protection

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Introduction to Respiratory Protection Standards

General introduction

Many different ways can lead to local, regional or international standards, specifications or guidance documents. In some regions, standards are an important element during the certification process. Generally, the term “standard” can have different meanings, sometimes only slight differences lead to unexpected consequences. Therefore, it is important to consider the “standards world” in which oneself needs to be active.

Respiratory standards exist on a global basis as well as in regions and countries worldwide. Many of them are currently under development or revision on different levels, in different organizations and in very diverse stages.

It is the intention of the ISRP to give guidance by supporting its members and the respiratory community with information on respiratory standards for a deeper understanding of the actual standardization situation.

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United States of America

In the US, the CDC (Centers for Disease Control and Prevention (www.cdc.gov)) and its branch NIOSH (The National Institute for Occupational Safety and Health (https://www.cdc.gov/niosh/)) develop standards

The central respiratory standard published and maintained by NIOSH is “42 CFR Part 84 Respiratory Protective Devices” (https://www.cdc.gov/niosh/npptl/topics/respirators/pt84abs2.html)

Recent Standards

ASTM International has announced the publication of ASTM F3407-20 Standard Test Method for Respirator Fit Capability (RFC) for Negative-Pressure Half-Facepiece Particulate Respirators. This standard may enable respirator manufacturers to design and develop better fitting air-purifying particulate only respirators, including filtering facepiece respirators.  Better designed models that demonstrate fitting the worker population can result in lower costs to occupational respiratory protection programs. Purchasers of particulate only respirators may be able to reference ASTM F3407 in their procurement packages to ensure receiving respirators with preferable fitting characteristics. Conformity assessment program scheme owners, such as the National Institute for Occupational Safety and Health (NIOSH), may be able to adopt and use the RFC standard. Check out the ASTM news release to learn more information!

Canada

The Standards Council of Canada oversees standards development within Canada. Standards relevant to respiratory protection are developed by the Canadian Standards Association (CSA Group) and the Canadian General Standards Board.

The standards following include various aspects of respiratory protection, and are referred to by various provincial and federal regulatory bodies. The preface “CAN” means the document is a national standard of Canada.

  • CAN/CSA Z94.4-18 Selection, use, and care of respirators
  • CSA Z180.1-19 Compressed breathing air and systems
  • CAN/CGSB/CSA-Z1610-11 (R2016) Protection of first responders from chemical, biological, radiological, and nuclear (CBRN) events
  • CAN/CGSB/CSA-Z1640-18 Personal protective equipment (PPE) for investigating and dismantling clandestine drug laboratories
Standards organization

Canadian Standards Association

Standard number CAN/CSA Z94.4
Standard title Selection, use and care of respirators
URL

Standard (Purchase)

Standard Status

Meeting date 2020-10-02
Meeting location Virtual
Contact CSA Group Contact
Committee eligibility Any qualified with approval of chair
Type of product Standard is intended to cover Respirator
Other info None at this time

Europe

In the European Committee for Standardizations CEN, the Technical Committee TC 79 “Respiratory protective devices” is responsible for the development of product standards, test methods and selection and use guidance:

(https://standards.cen.eu/dyn/www/f?p=204:7:0::::FSP_ORG_ID:6062&cs=1FE6D4AE51AA3AA72A7024518C8767D1B).

After its reactivation in 2012, standards on filters for reusable masks and standards on assisted devices for hood and mask respiratory interfaces were the first to undergo revision.

European Community Face Covering Standards

People's Republic of China

The Standardization Administration of the People's Republic of China (SAC) is responsible for the publication of respiratory standards. (http://www.sac.gov.cn/)

The Chinese committee SAC/TC 112 “Technical Committee on individual protection equipment” is responsible for respiratory standards, e.g. GB2626 “Respiratory protection -Non-powered air-purifying particle respirator” or GB 2890 “Respiratory protection - Non-powered air-purifying respirators”.

Global

A standardization system is under development in ISO Technical Committee 94 Sub Committee 15 ISO/TC 94/SC 15 “Respiratory Protective devices” (https://www.iso.org/committee/291088/x/catalogue/). This system puts the wearer in the center and defines human factors, test methods, selection and use guidance and performance requirement standards. The selection and use standards present ISO 16975-3 “Respiratory protective devices - Selection, use and maintenance - Part 3: Fit-testing procedures”, giving information on qualitative and quantitative fit testing methods and the actual procedures.

In 2020 work started on ISO/TS 16975-4 “Respiratory protective devices — Selection, use and maintenance — Part 4: Guideline for respiratory protective devices under pandemic of infectious respiratory disease”.