ISO/TC 94/SC 15 - Respiratory protective devices

This document specifies the requirements for respiratory protective devices for use by workers during response to incidents involving chemical, biological radiological or nuclear (CBRN) materials used with intent to cause harm or in cases of accidental release outside traditional hazardous materials response categories. For the purposes of this document, all incidents described here are named CBRN incidents. This document is applicable to RPD for use by personnel in the following roles: — First responders: including police, fire service, emergency medical, search and rescue, sampling and detection teams. — Workers needed for specific roles during response (utility, transportation, service continuity). — Medical personnel working with casualties of CBRN incidents. — Responders to release incidents involving nuclear materials. — Non-emergency but CBRN-related roles. — Workers in need of protection during escape from a CBRN or radiological release incident. — Workers in need of protection from nuclear materials. The requirements for RPD use by the following groups are not addressed by this document: — Military personnel outside of first responder roles. — Children. — Animals. Requirements for the following are not covered by this document: — Collective protection systems including ventilated casualty/body bags. — Methods of and criteria for decontamination of RPD. — Disposal of used equipment. This document is focused on respiratory protection requirements, but it is recognised that CBRN RPD are always used as part of an ensemble with protective clothing. The total ensemble effectiveness is not covered by this document.

This document specifies the requirements for respiratory protective devices for use by workers during response to incidents involving chemical, biological, radiological or nuclear (CBRN) materials used with intent to cause harm or in cases of accidental release outside traditional hazardous materials response categories. For the purposes of this specification, all incidents described here are named CBRN incidents. This document is applicable to RPD for use by personnel in the following roles: — First responders: including police, fire service, emergency medical, search and rescue, sampling and detection teams. — Workers needed for specific roles during response (utility, transportation, service continuity). — Medical personnel working with casualties of CBRN incidents. — Responders to release incidents involving nuclear materials. — Non-emergency but CBRN-related roles. — Workers in need of protection during escape from a CBRN or radiological release incident. — Workers in need of protection from nuclear materials. The requirements for RPD use by the following groups are not addressed by this document: — Military personnel outside of first responder roles. — Children. — Animals. Requirements for the following are not covered by this document: — Collective protection systems including ventilated casualty/body bags. — Methods of and criteria for decontamination of RPD. — Disposal of used or contaminated equipment. This document is focused on respiratory protection requirements, but it is recognised that CBRN RPD are always used as part of an ensemble with protective clothing. The total ensemble effectiveness is not covered by this document.

This document specifies the method of test for the mechanical resistance and strength of components of respiratory protective devices.

This document specifies the minimum requirements for supplied breathable gas RPD and filtering RPD to be used for special application fire and rescue services.

This document specifies the requirements for supplied breathable gas RPD and for filtering RPD to be used for special application escape for use in the workplace to protect the wearer.

This document specifies the requirements for supplied breathable gas respiratory protective device (RPD) and filtering RPD to be used for special application marine, mining, welding and abrasive blasting for use in the workplace to protect the wearer.

This document specifies requirements for the performance and testing of filtering respiratory protective devices (RPD) in accordance with their classification and for use in the workplace to protect the wearer from hazardous atmospheres and/or environments. Requirements for RPD elements and components are also specified in this document.

This document specifies general requirements for the performance and testing of respiratory protective devices (RPD) in accordance with their classification and for use in the workplace to protect the wearer from hazardous atmospheres and/or environments. The requirements are based on human factors and are for complete respiratory systems. Requirements for marking and information supplied by the RPD manufacturer are also included. Additional requirements for special application such as fire services, marine, mining, abrasive blasting, welding and escape as well as RN (Radiological, Nuclear), CBRN (Chemical, Biological, Radiological, Nuclear) and CBRN Escape RPD are addressed in ISO 17420-5 to ISO 17420-9. This document does not apply to respiratory devices for: — underwater diving application; — military application; — use in aircraft and spacecraft; — medical life support applications; — resuscitators.

This document specifies requirements for the performance and testing of supplied breathable gas respiratory protective devices (RPD) in accordance with their classification and for use in the workplace to protect the wearer from hazardous atmospheres and/or environments.

This document specifies laboratory test methods for measuring the sound pressure level generated by the respiratory protective device (RPD) and by RPD warning devices, measured on a headform to which the RPD is fitted.

This document specifies practical performance tests for respiratory protective devices. The purpose of these tests is to subjectively assess certain properties, characteristics and functions of the RPD, when worn by test subjects in simulated practical use, which cannot be assessed by tests described in other standards.

This document is one part of a series of Technical Specifications that provide information on factors related to human anthropometry, physiology, ergonomics and performance for the preparation of standards for design, testing and use of respiratory protective devices. This document contains information related to thermal effects of respiratory protective devices on the human body. In particular information is given for: — temperatures of surfaces associated with discomfort sensation and harmful effects on human tissues; — thermal effects of breathing gas temperatures on lung airways and tissues; — effects of breathing gas temperature and humidity on respiratory heat exchange; — effects of respiratory protective devices on overall body heat exchange. The information represents data for adult healthy men and women in the age 20 years to 60 years.

This document defines terms and specifies units of measurement for respiratory protective devices (RPDs), excluding diving apparatus. It indicates graphical symbols that can be required on RPDs, parts of RPD or instruction manuals in order to instruct the person(s) using the RPD as to its operation. NOTE Terms and definitions for diving apparatus are given in EN 250.

This document contains information related to the interaction between respiratory protective devices and the human body functions of hearing and speech.

This document specifies the test methods for determining inward leakage of respiratory interfaces (RI) and total inward leakage of complete respiratory protective devices (RPD) using specified test agents and incorporating specified body movements, at specified metabolic work rates. These tests are conducted in laboratories using specific test agents under specified conditions and therefore do not indicate the performance of the device in actual use.

This document describes how to calculate the work performed by a person's respiratory muscles with and without the external respiratory impediments that are imposed by RPD of all kinds, except diving equipment. This Document describes how much additional impediment people can tolerate and contains values that can be used to judge the acceptability of an RPD. NOTE These calculations are explained in some textbooks on respiratory physiology (in the absence of an RPD), but most omit them or are incomplete in their explanations.

This document gives: — a description of the composition of the Earth's atmosphere; — a description of the physiology of human respiration; — a survey of the current biomedical literature on the effects of carbon dioxide and oxygen on human physiology; — examples of environmental circumstances where the partial pressure of oxygen or carbon dioxide can vary from that found at sea level. This document identifies oxygen and carbon dioxide concentration limit values and the length of time within which they would not be expected to impose physiological distress. To adequately illustrate the effects on human physiology, this document addresses both high altitude exposures where low partial pressures are encountered and underwater diving, which involves conditions with high partial pressures. The use of respirators and various work rates during which RPD can be worn are also included.

ISO 16900-2:2017 specifies the method(s) of test for breathing resistance for - respiratory protective devices (RPDs), - filters for RPDs, and - respiratory interfaces (RI).

ISO 16975-3:2017 specifies guidance on how to conduct fit testing of tight-fitting respiratory protective device (RPD) and on appropriate methods to be used. Fit testing is only one element of a complete RPD programme. The intention of fit testing is to evaluate the effectiveness of the seal between the wearer's face and the respiratory interface (RI). A complete RPD programme is defined in ISO/TS 16975‑1. ISO 16975-3:2017 specifies requirements for conducting RPD fit testing and includes - qualifications/competences of fit-test operators, - specific fit-testing procedures, - interpretation of fit-test results, and - record keeping. A fit test is not required for escape-only RPD.

ISO 16900-5:2016 specifies the characteristics of breathing machines, metabolic simulators, RPD head forms/torso, RPD tools and RPD verification tools that are common to RPD test laboratories. Standardization of these items is essential for the standardization of the test methods. Standardization of the RPD verification tools is essential for demonstrating the delivery of comparable results in different test laboratories. Descriptions on the use of the RPD tools for the different tests are specified in the relevant parts of ISO 16900.

ISO/TS 16975-1:2016 specifies detailed information to assist persons responsible for establishing and implementing a programme for respiratory protective devices (RPD) that meet the performance requirements of the performance standards. It does not apply to RPD programmes for RPD used exclusively under water, for use in aircraft, and medical life support respirators and resuscitators. NOTE The information contained in this part of ISO 16975 can be used to assist in the preparation of national or local regulations; however, this part of ISO 16975 does not supersede national or local regulations. WARNING ? Failure to select, use and maintain RPD correctly can result in injury, illness or death.

ISO/TS 16975-2:2016 provides brief guidance to assist persons responsible for establishing and implementing a programme for respiratory protective devices (RPD) that meet the performance requirements. There are special applications where the selection of suitable RPD using this guide is not appropriate. These are: a) Fire Fighting ? structural and wildland firefighting, hazardous materials and rescue applications; b) CBRN (Chemical, Biological, Radiological and Nuclear agents); c) Marine ? shipboard or off-shore firefighting or hazardous materials applications; d) Mining ? underground mining or firefighting and rescue applications; and e) Escape ? general, fire, CBRN, marine and mining. NOTE 1 For more detailed information relating to the special applications, refer to ISO/TS 16975‑1. This guidance does not apply to selecting RPD against bio aerosols. NOTE 2 Reference [3] addresses selection of RPD for bio aerosols that are capable of causing infection or adverse or allergic response but for which no occupational exposure limits have been established. This guidance does not apply to RPD programmes for RPD used exclusively under water, in aircraft, and medical life support respirators and resuscitators.

ISO 16900-12:2016 specifies the test methods for determining the volume-averaged work of breathing and peak respiratory pressures imposed by the respiratory protective device (RPD). Elastic work, elastic physiological effects, and information on physiological effects of work of breathing (WOB) are specified in ISO 16976‑4 and are not included in this test method.

ISO/TS 16973:2016 specifies the classification of Respiratory Protective Devices based on their performance. The performance requirements are given in the relevant performance standards.

ISO/TS 16976-1:2015 provides information on factors related to human anthropometry, physiology, ergonomics, and performance for the preparation of standards for performance requirements, testing, and use of respiratory protective devices. This part of ISO/TS 16976 contains information related to respiratory and metabolic responses to rest and work at various intensities. Information is provided for the following: - metabolic rates associated with various intensities of work; - oxygen consumption as a function of metabolic rate and minute ventilation for persons representing three body sizes; - peak inspiratory flow rates during conditions of speech and no speech for persons representing three body sizes as a function of metabolic rates. The information contained within this part of ISO/TS 16976 represents data for healthy adult men and women of approximately 30 years of age, b

ISO 16900-9:2015 specifies the test methods for determining the increased carbon dioxide content of the inhaled gas caused by wearing the RPD. Closed circuit supplied breathable gas RPD are excluded from ISO 16900-9:2015. NOTE See test method in ISO 16900‑13.

ISO 16900-13:2015 specifies tests which are specific to RPDs using regenerated breathable gas, compressed breathable gas with class L respiratory interfaces, and special application mining escape RPD.

ISO 16900-10:2015 specifies the methods for resistance to ignition, flame, radiant heat, and heat.

ISO 16900-8:2015 specifies the methods for measuring air flow rates delivered to the wearer by an assisted filtering RPD.

ISO/TS 16976-2:2015 is one part of a series of Technical Specifications that provide information on factors related to human anthropometry, physiology, ergonomics, and performance for the preparation of standards for design, testing, and use of respiratory protective devices. It contains information related to anthropometry. In particular, information is given for: ? anthropometric measurement methods; ? anthropometric data for head, face, and neck dimensions; ? anthropometric data for torso dimensions; ? human test panels; ? models of headforms.

ISO/TS 16976-6:2014 provides information on the psycho-physiological effects related to the wearing of respiratory protective devices (RPD) and it is intended for the preparation of standards for selection and use of RPD. It specifies for the writers of RPD standards, principles relating to the interaction between RPD and the human physiological and psychological perception, the acceptance by the wearer, and the need for training to improve acceptance of the RPD by the wearer. ISO/TS 16976-6:2014 does not cover requirements related to the specific hazard for which the RPD is designed.

ISO 16900-11:2013 specifies the laboratory test method for determining the field of vision for a respiratory protective device (RPD).

ISO/TS 16976-8:2013 gives guidance on the generic ergonomic factors for the preparation of standards for performance requirements, testing and use of respiratory protective devices (RPD). It specifies principles relating to: the biomechanical interaction between RPD and the human body; the interaction between RPD and the human senses: vision, hearing, smell, taste and skin contact.

ISO 16900-3:2012 specifies the test methods for particle filter penetration of separate or integral filters for respiratory protective devices.

ISO 16900-4:2011 specifies the test method for determining gas capacity of separate or integral gas and combined filters for respiratory protective systems. ISO 16900-4:2011 includes the validation test at specified flow rates, a desorption test to access the ability of the filter to retain the adsorbed or absorbed gas, and carbon monoxide dynamic testing.

ISO 16900-14:2015 specifies a laboratory test method for determining the sound level generated by the complete respiratory protective device (RPD) and RPD warning sounds measured on a headform to which the RPD is fitted.

ISO 16900-6:2015 specifies the method of test for the mechanical resistance and strength of components of respiratory protective devices.

ISO 16900-7:2015 specifies practical performance tests for respiratory protective devices (RPD). The purpose of these tests is to subjectively assess certain properties, characteristics, and functions of the RPD when worn by test subjects in simulated practical use, which cannot be assessed by tests described in other standards.

ISO 16900-1:2014 specifies the test methods for determining inward leakage of respiratory interfaces (RI) and total inward leakage of complete respiratory protective devices (RPD) using specified test agents and incorporating specified body movements, at specified metabolic work rates. These tests are conducted in laboratories using specific test agents under specified conditions and therefore do not indicate the performance of the device in actual use.

ISO/TS 16976-5:2013 is one of a series of Technical Specifications that provide information on factors related to human anthropometry, physiology, ergonomics and performance for the preparation of standards for design, testing and use of respiratory protective devices. It contains information related to thermal effects of respiratory protective devices on the human body, in particular: temperatures of surfaces associated with discomfort sensation and harmful effects on human tissues; thermal effects of breathing gas temperatures on lung airways and tissues; effects of breathing gas temperature and humidity on respiratory heat exchange; effects of respiratory protective devices on overall body heat exchange. The information represents data for adult healthy men and women aged between 20 and 60 years.

ISO/TS 16976-7:2013 contains information related to the interaction between respiratory protective devices and the human body functions of hearing and speech.

ISO/TS 16976-4:2012 describes how to calculate the work performed by a person's respiratory muscles with and without the external respiratory impediments that are imposed by RPD of all kinds, except diving equipment. ISO/TS 16976-4:2012 describes how much additional impediment people can tolerate and contains values that can be used to judge the acceptability of an RPD.

ISO/TS 16976-3:2011 gives: a description of the factors contributing to the present content of the Earth's atmosphere; a description of the physiology of human respiration; a survey of the current biomedical literature on the effects of carbon dioxide and oxygen on human physiology; examples of environmental circumstances where the partial pressure of oxygen or carbon dioxide can vary from that found at sea level. ISO/TS 16976-3:2011 identifies oxygen and carbon dioxide concentration limit values and the length of time within which they would not be expected to impose physiological distress. To adequately illustrate the effects on human physiology, ISO/TS 16976-3:2011 addresses both high altitude exposures where low partial pressures are encountered, and underwater diving, which involves conditions with high partial pressures. The use of respirators and various work rates during which RPD can be worn are also included.

ISO/TS 16974:2011 gives guidance on the marking to be used on respiratory protective devices (RPD) and the information to be supplied by the manufacturer/supplier.

ISO/TS 16976‑2:2010 is one part of a series of technical specifications that provide information on factors related to human anthropometry, physiology, ergonomics and performance for the preparation of standards for design, testing and use of respiratory protective devices. ISO/TS 16976‑2:2010 contains information related to anthropometry. In particular, information is given for: anthropometric measurement methods; anthropometric data for head, face and neck dimensions; anthropometric data for torso dimensions; human test panels; models of headforms.

ISO 16972:2010 is applicable to respiratory protective devices. It defines commonly used terms and specifies units of measurement to achieve a uniform interpretation and to prevent ambiguous use. It indicates graphical symbols that may be required to be placed on respiratory protective devices (RPD) or parts of RPD or instruction manuals, in order to instruct the person(s) using the RPD about its operation.

ISO 16900-2:2009 specifies the method(s) of test for breathing resistance for: complete respiratory protective devices; filters for respiratory protective devices; respiratory interfaces.

ISO/TS 16976-1:2007 is part of a series that provides information on factors related to human anthropometry, physiology, ergonomics and performance, for the preparation of standards for performance requirements, testing and use of respiratory protective devices. ISO/TS 16976-1:2007 contains information related to respiratory and metabolic responses to rest and work at various intensities. Information is provided for: metabolic rates associated with various intensities of work; oxygen consumption as a function of metabolic rate and minute ventilation for persons representing three body sizes; peak inspiratory flow rates during conditions of speech and no speech for persons representing three body sizes as a function of metabolic rates. The information contained within ISO/TS 16976-1:2007 represents data for healthy adult men and women of approximately 30 years of age, but is applicable for the age range of the general population.