NFPA1999 Standard on Protective Clothing and Ensembles for Emergency Medical Operations

Chapter 1 Administration
1.1 Scope.
1.1.1* This standard shall specify the minimum design, performance, testing, documentation, and certification requirements for new single-use and new multiple-use emer¬gency medical operations protective clothing, including garments, helmets, gloves, footwear, and face protection devi¬ces, used by emergency medical responders prior to arrival at medical care facilities, used by medical first receivers at medical care facilities during emergency medical operations, and used by health care workers providing medical and supportive care.
1.1.2 This standard shall also specify additional minimum design, performance, testing, documentation, and certification as requirements for single-use and multiple-use emergency medical protective ensembles comprising the protective cloth¬ing items described in 1.1.1 for protection from airborne and liquid-borne pathogens.
1.1.3* This standard shall not be interpreted as specifying requirements for protection from chemical, biological, radioac¬tive, and nuclear (CBRN) terrorism agents, from radiological agents, from hazardous chemicals, from flammable or explo¬sive atmospheres, or from thermal hazards.
1.1.4 This standard shall also specify requirements for respira¬tory protective devices that are not already covered in 42 CFR 84, “Approval for Respiratory Protective Devices,” that are intended for emergency medical operations by first responders, first receivers, and health care workers providing medical and supportive care.
1.1.5* Certification of all emergency medical ensemble elements and protective clothing items, and medical care facility ensemble elements and protective clothing items, as compliant with the requirements of this standard, shall not preclude certification to additional appropriate standards where the ensemble elements or protective clothing items meet all applicable requirements of each standard.
1.1.6* This standard shall not be construed as addressing all of the safety concerns associated with the use of compliant emergency medical operations protective clothing for the protection of their personnel. It shall be the responsibility of the persons and organizations that use this standard to conduct testing of protective clothing to establish safety and health practices and determine the applicability of regulatory limita¬tions prior to using this standard for any designing, manufac¬turing, and testing.
1.1.7 This standard shall not be construed as addressing all of the safety concerns, if any, associated with the use of this stand¬ard by testing facilities. It shall be the responsibility of the persons and organizations that use this standard to conduct testing of protective clothing and ensembles to establish safety and health practices and determine the applicability of regula¬tory limitations prior to using this standard for any designing, manufacturing, and testing.
1.1.8* This standard shall not specify requirements for any accessories that could be attached to the certified product but are not necessary for the certified product to meet the require¬ments of this standard.
1.1.9 Nothing herein shall restrict any jurisdiction or manu¬facturer from exceeding these minimum requirements.
1.2 Purpose.
1.2.1* The purpose of this standard shall be to establish a minimum level of protection from contact with blood and body fluid-borne pathogens for personnel performing patient care during emergency medical operations.
1.2.2 The purpose of this standard shall also be to establish a minimum level of whole body protection for emergency serv¬ices personnel and medical first receivers from airborne and liquid-borne pathogens.
1.2.3 To achieve these purposes, this standard shall establish for emergency medical responders and medical first receivers the minimum requirements for upper and lower torso, head, hands, foot, and face protection devices to minimize skin and mucous membrane contact with body fluid-borne pathogens.
1.2.4 Controlled laboratory tests used to determine compli¬ance with the performance requirements of this standard shall not be deemed as establishing performance levels for all situa¬tions to which personnel can be exposed.
1.2.5* This standard shall not be interpreted or used as a detailed manufacturing or purchase specification but shall be permitted to be referenced in purchase specifications as mini¬mum requirements.
1.3 Application.
1.3.1 This standard shall apply to the design, performance, testing, and certification of new emergency medical garments, emergency medical examination gloves, emergency medical helmets, emergency medical cleaning/utility gloves, emergency medical work gloves, emergency medical facemasks, emergency medical face protection devices, emergency medical footwear and footwear covers, care facility footwear, and single-use and multiple-use emergency protective ensembles.
1.3.2 This edition of NFPA 1999 shall not apply to any emer¬gency medical operations protective clothing manufactured to previous editions of this standard.
1.3.3 This standard shall not apply to any emergency medical operations protective clothing manufactured to the require¬ments of any other standard.
1.3.4* Other than the certification of emergency medical protective ensembles to the single-use and multiple-use ensem¬ble requirements of this standard, this standard shall not apply to respiratory protection in emergency medical operations, as such requirements are specified by NIOSH in 42 CFR 84, and by OSHA in 29 CFR 1910.134 and 29 CFR 1910.1030.
1.3.5 This standard shall not apply to the use of or conditions of use for emergency medical protective clothing and ensem¬bles by emergency medical responders and medical first receiv¬ers.
1.3.6 This standard shall not apply to any accessories that could be attached to the certified product, before or after purchase, but are not necessary for the certified product to meet the requirements of this standard.
1.4 Units.
1.4.1 In this standard, values for measurement are followed by an equivalent in parentheses, but only the first stated value shall be regarded as the requirement.
1.4.2 Equivalent values in parentheses shall not be considered as the requirement as these values are approximate.
Chapter 2 Referenced Publications
2.1 General. The documents or portions thereof listed in this chapter are referenced within this standard and shall be considered part of the requirements of this document.
2.2 NFPA Publications. National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169-7471.
NFPA 704, Standard System for the Identification of the Hazards of Materials for Emergency Response, 2017 edition.
NFPA 1500, Standard on Fire Department Occupational Safety, Health, and Wellness Program, 2018 edition.
NFPA 1581, Standard on Fire Department Infection Control Program, 2015 edition.
NFPA 1951, Stan dard on Protective Ensembles for Technical Rescue Incidents, 2013 edition.
NFPA 1971, Standard on Protective Ensembles for Structural Fire Flatting and Proximity Fire Fighting, 2018 edition.
NFPA 1991, Standard on Vapor-Protective Ensembles for Hazard¬ous Materials Emergencies and CBRN Terrorism Incidents, 2016 edition.
NFPA 1992, Standard on Liquid Splash-Protective Ensembles and Clothing for Hazardous Materials Emergencies, 2018 edition.
NFPA 1994, Standard on Protective Ensembles for First Responders to Hazardous Materials Emergencies and CBRN Terrorism Incidents, 2018 edition. Psychological Corporation Publications. Psychological Corporation, 555 Academic Court, San Antonio, TX 78204.
Crawford Small Parts Dexterity Test, 1981.
2.3.1 U.S. Government Publications. U.S. Government Publishing Office, 732 North Capitol Street, NW, Washington, DC 20401-0001.
Title 29, Code of Federal Regulations, Part 1910.132, “General Requirements of Subpart I, Personal Protective Equipment.”
Title 29, Code of Federal Regulations, Part 1910.134, “Respi¬ratory Protection.”
Title 29, Code of Federal Regulations, Part 1910.1030, “Protecting Health Care Workers from Occupational Exposure to Blood-Borne Pathogens.”
Title 42, Code of Federal Regulations, Part 84, “Approval of Respiratory Protective Devices.”
2.3.2 Department of Defense Publications. Standardization Documents Order Desk, Building 4D, 700 Robbins Avenue, Philadelphia, PA 19111-5094.
A-A-55126B, Commercial Item Description: Fastener Tapes, Hook and Loop, Pile, Synthetic, 2006.
A-A-55634A, Commercial Item Description: Zippers (Fasteners, Slide, Interlocking), 2004.
2.3.3 Other Publications.
Merriam-Webster’s Collegiate Dictionary, 11th edition, Merriam- Webster, Inc., Springfield, MA, 2003.
2.4 References for Extracts in Mandatory Sections. (Reserved)
Chapter 3 Definitions
3.1 General. The definitions contained in this chapter shall apply to the terms used in this standard. Where terms are not defined in this chapter or within another chapter, they shall be defined using their ordinarily accepted meanings within the context in which they are used. Merriam-Webster’s Collegiate Dictionary, 11th edition, shall be the source for the ordinarily accepted meaning.
3.2 NFPA Official Definitions.
3.2.1* Approved. Acceptable to the authority having jurisdic¬tion.
3.2.2* Authority Having Jurisdiction (AHJ). An organization, office, or individual responsible for enforcing the requirements of a code or standard, or for approving equipment, materials, an installation, or a procedure.
3.2.3 Labeled. Equipment or materials to which has been attached a label, symbol, or other identifying mark of an organ¬ization that is acceptable to the authority having jurisdiction and concerned with product evaluation, that maintains peri¬odic inspection of production of labeled equipment or materi¬als, and by whose labeling the manufacturer indicates compliance with appropriate standards or performance in a specified manner.
3.2.4* Listed. Equipment, materials, or services included in a list published by an organization that is acceptable to the authority having jurisdiction and concerned with evaluation of products or services, that maintains periodic inspection of production of listed equipment or materials or periodic evalua¬tion of services, and whose listing states that either the equip¬ment, material, or service meets appropriate designated standards or has been tested and found suitable for a specified purpose.
3.2.5 Shall. Indicates a mandatory requirement.
3.2.6 Should. Indicates a recommendation or that which is advised but not required.
3.2.7 Standard. An NFPA Standard, the main text of which contains only mandatory provisions using the word “shall” to indicate requirements and that is in a form generally suitable for mandatory reference by another standard or code or for adoption into law. Nonmandatory provisions are not to be considered a part of the requirements of a standard and shall be located in an appendix, annex, footnote, informational note, or other means as permitted in the NFPA Manuals of Style. When used in a generic sense, such as in the phrase “standards development process” or “standards development activities,” the term “standards” includes all NFPA Standards, including Codes, Standards, Recommended Practices, and Guides.
3.3* General Definitions.
3.3.1 Accessories. An item, or items, that are attached to the certified product that are not necessary to meet the require¬ments of the standard.
3.3.2 Afterflame. Persistent flaming of a material after the ignition source has been removed.
3.3.3 Afterflame Time. The length of time for which a mate¬rial continues to flame after the ignition source has been removed.
3.3.4 Arch. The bottom curve of the foot from the heel to the ball.
3.3.5 Barrier Layer. The layer of garment material, glove material, footwear material, or face protection device material designated as providing body fluid-borne pathogen resistance.
3.3.6 Biological Terrorism Agents. Liquid or particulate agents that can consist of biologically derived toxin or patho¬gen to inflict lethal or incapacitating casualties.
3.3.7 Body Fluid-Borne Pathogen. An infectious bacterium or virus carried in human, animal, or clinical body fluids organs, or tissue.
3.3.8 Body Fluids. Fluids that are produced by the body, including, but not limited to, blood, semen, mucus, feces, urine, vaginal secretions, breast milk, amniotic fluid, cerebro¬spinal fluid, synovial fluid, sweat, vomit, and pericardial fluid.
3.3.9 Brim. A part of the shell of the helmet that extends around the entire circumference of the helmet.
3.3.10 Certification/Certified. A system whereby a certifica¬tion organization determines that a manufacturer has demon¬strated the ability to produce a product that complies with the requirements of this standard, authorizes the manufacturer to use a label on listed products that comply with the require¬ments of this standard, and establishes a follow-up program conducted by the certification organization as a check on the manufacturer to determine compliance with the requirements of this standard.
3.3.11 Certification Organization. An independent, third- party organization that determines product compliance with the requirements of this standard with a labeling/listing/ follow-up program.
3.3.12 Combined Performance Material. A retroreflective material that is also a fluorescent material.
3.3.13 Compliance/Compliant. Meeting or exceeding all applicable requirements of this standard.
3.3.14 Compliant Product. Product that is covered by this standard and has been certified as meeting all applicable requirements of this standard that pertain to the product.
3.3.15 Component(s). Any material, part, or subassembly used in the construction of the compliant product.
3.3.16 Crown. The portion of the helmet that covers the head above the reference plane.
3.3.17 Crown Straps. The part of the helmet suspension that passes over the head.
3.3.18 Elastomer. A polymeric material that returns to its orig¬inal length and shape after stretching.
3.3.19 Elastomer Interface Material. An exposed elastomeric material that is not otherwise used as a garment material, which provides an interface between components of the ensemble or ensemble elements, and if applicable, the inter¬face between the respirator facepiece and the ensemble or ensemble elements.
3.3.20 Elements. See 3.3.35, Ensemble Elements.
3.3.21* Emergency Medical Cleaning/Utility Glove. Multipur¬pose glove that provides a barrier against body fluids, cleaning fluids, and disinfectants and limited physical protection to the wearer.
3.3.22 Emergency Medical Examination Glove. An element or item of emergency medical protective ensemble or protective clothing that is designed and configured to provide barrier protection to the wearer’s hand to at least the wrist. (See 3.3.33, Emergency Medical Work Glove.)
3.3.23* Emergency Medical Eye and Face Protection Device.
An item of emergency medical protective clothing that is designed and configured to provide barrier protection to the wearer’s eyes, face, or both eyes and face.
3.3.24* Emergency Medical Facemask. An item of emergency medical protective clothing that is designed and configured to provide protection to the wearer’s face including the mucous membrane area of the wearer’s nose and mouth.
3.3.25 Emergency Medical Footwear. An element or item of emergency medical protective ensemble or protective clothing that is designed and configured to provide barrier protection to the wearer’s feet.
3.3.26 Emergency Medical Footwear Cover. An element or item of emergency medical protective ensemble or protective clothing designed and configured to be worn over standard footwear to provide barrier and limited physical protection to the wearer’s feet.
3.3.27* Emergency Medical Garment. An element or item of emergency medical protective ensemble or protective clothing designed and configured as a single garment or an assembly of multiple garments to provide barrier protection to the wearer’s upper and lower torso, excluding the hands, face, and feet.
3.3.28 Emergency Medical Helmet. An item of emergency medical protective clothing designed and configured to provide protection to the wearer’s head.
3.3.29* Emergency Medical Operations. Provision of emer¬gency patient care and transportation prior to arrival at a medi¬cal care facility by emergency medical responders, emergency patient care by medical first receivers at a medical care facility, and body recovery by emergency medical responders.
3.3.30 Emergency Medical Powered Air-Purifying Respirator.
An element or item of an emergency medical protective ensem¬ble designed and configured to provide respiratory protection to the wearer from airborne infectious diseases, to act as a barrier, and to provide limited physical protection to the wear¬er’s head and neck.
3.3.31* Emergency Medical Protective Clothing. Items of both single-use and multiple-use protective clothing that provide limited physical protection and barrier protection against body fluid-borne pathogen contact with the wearer’s body during delivery of emergency patient care and other emergency medical functions. (See 3.3.21, Emergency Medical Cleaning/Utility Glove; 3.3.22, Emergency Medical Examination Glove; 3.3.23, Emergency Medical Eye and Face Protection Device; 3.3.24, Emergency Medical Facemask; 3.3.25, Emergency Medical Footwear; 3.3.26, Emergency Medical Footwear Cover; 3.3.27, Emer¬gency Medical Garment; 3.3.28, Emergency Medical Helmet; and 3.3.33, Emergency Medical Work Glove.)
3.3.32 Emergency Medical Responders. Emergency services response personnel who perform emergency medical opera¬tions prior to arrival at a medical care facility.
3.3.33 Emergency Medical Work Glove. An element or item of emergency medical protective ensemble or protective cloth¬ing that is designed and configured to provide physical and barrier protection to the wearer’s hand and wrist. (See also 3.3.22, Emergency Medical Examination Glove.)
3.3.34 Emergency Patient Care. Treatment of patients by emergency medical responders or medical first receivers including first aid, cardiopulmonary resuscitation, basic life support, advanced life support, and other medical procedures that occur prior to arrival at a medical care facility, or after arrival at a medical care facility.
3.3.35 Ensemble Elements. The compliant products that provide protection to the upper and lower torso, arms, legs, head, hands, and feet.
3.3.36 Examination Glove. An abbreviated term for emer¬gency medical examination glove. (See also 3.3.22, Emergency Medical Examination Glove.)
3.3.37 Fluorescence. A process by which radiant flux of certain wavelengths is absorbed and reradiated non-thermally in other, usually longer, wavelengths.
3.3.38 Follow-Up Program. The sampling, inspections, tests, or other measures conducted by the certification organization on a periodic basis to determine the continued compliance of labeled and listed products that are being produced by the manufacturer to the requirements of this standard.
3.3.39 Footwear. An abbreviated term for emergency medical footwear. (See also 3.3.25, Emergency Medical Footwear.)
3.3.40 Footwear Cover. An abbreviated term for emergency medical footwear cover. (See also 3.3.26, Emergency Medical Foot¬wear Cover.)
3.3.41 Garment. An abbreviated term for emergency medical garment. (See also 3.3.27, Emergency Medical Garment.)
3.3.42 Garment Closure. The garment component designed and configured to allow the wearer to enter (don) and exit (doff) the garment.
3.3.43 Garment Closure Assembly. The combination of the garment closure and the seam attaching the garment closure to the garment, excluding any protective flap or cover.
3.3.44 Garment Material. All material layers used in the construction of emergency medical garments other than patches, reinforcements, and visibility markings.
3.3.45 Glove. See 3.3.21, Emergency Medical Cleaning/Util¬ity Glove; 3.3.22, Emergency Medical Examination Glove; and 3.3.33, Emergency Medical Work Glove.
3.3.46 Glove Body. The part of the glove that extends from the tip of the fingers to the wrist crease or to a specified distance beyond the wrist crease.
3.3.47 Glove Material. All material layers used in the construction of gloves.
3.3.48* Gusset. The part of the protective footwear that is a relatively flexible material joining the footwear upper (quarter) and the tongue, which is intended to provide expansion of the footwear front to enable donning of the footwear while main¬taining continuous moisture integrity of the footwear.
3.3.49 Hazardous Materials. Any solid, liquid, gas, or mixture thereof that can potentially cause harm to the human body through respiration, ingestion, skin absorption, or contact.
3.3.50 Headform. A device that simulates the configuration of the human head.
3.3.51 Helmet. See 3.3.28, Emergency Medical Helmet.
3.3.52 Helmet Shell. A helmet without the suspension system, accessories, and fittings.
3.3.53 Insole. The inner part of the protective footwear upon which the foot rests and that conforms to the bottom of the foot.
3.3.54 Interface Component(s). Any material, part, or subas¬sembly used in the construction of the compliant product that provides limited protection to interface areas.
3.3.55 Manufacturer. The entity that directs and controls any of the following: compliant product design, compliant product manufacturing, or compliant product quality assurance; or the entity that assumes the liability for the compliant product or provides the warranty for the compliant product.
3.3.56* Medical Care Facility Footwear. An item of emer¬gency medical protective clothing that is designed and config¬ured to provide protection to the wearer’s feet and ankles at medical care facilities.
3.3.57 Medical First Receivers. Clinicians and other medical care staff at a medical care facility who have a role in emer¬gency patient care including initial triage, decontamination, and treatment for patients who are delivered by emergency medical services or who self-present at a medical care facility, and those staff whose roles support these functions, e.g., secur¬ity, set up, and patient tracking.
3.3.58 Medical Responders. See 3.3.32, Emergency Medical Responders.
3.3.59 Model. The collective term used to identify a group of individual elements or items of the same basic design and components from a single manufacturer produced by the same manufacturing and quality assurance procedures that are covered by the same certification.
3.3.60* Multiple Use. Items that are designed to be repeat¬edly worn and used for protection during emergency medical operations.
3.3.61* Multiple-Use Emergency Medical Protective Ensemble.
Multiple elements of compliant protective clothing and equip¬ment providing full body coverage, intended for multiple use, that when worn together provide protection from some risks, but not all risks, of emergency medical operations.
3.3.62 Nape Device. A device located below the Bitragion Inion Arc used to aid in helmet retention.
3.3.63 Package. The wrapping or enclosure direcdy contain¬ing a glove or face protection device.
3.3.64 Package Product Label. The product label that is prin¬ted on or attached to a package containing one or more compliant products. (See also 3.3.66, Product Label.)
3.3.65 Peak. An integral part of the helmet shell extending forward over the eyes only.
3.3.66* Product Label. A label or marking affixed to each compliant garment, glove, or face protection device by the manufacturer. (See also 3.3.64, Package Product Label.)
3.3.67 Radiological Particulate Terrorism Agents. Particles that emit ionizing radiation in excess of normal background levels, used to inflict lethal or incapacitating casualties, gener¬ally on a civilian population as a result of terrorist attack.
3.3.68 Retroreflection. The reflection of light in which the reflected rays are preferentially returned in the direction close to the opposite of the direction of the incident rays, with this property being maintained over wide variations of the direction of the incident rays.
3.3.69 Retroreflective Markings. A material that reflects and returns a relatively high proportion of light in a direction in the direction close to the direction from which it came.
3.3.70 Safety Alert. The action by which a manufacturer iden¬tifies a specific compliant product or a compliant product component, provides notice to users of the compliant product, and informs the marketplace and distributors of potential safety concerns regarding the product or component.
3.3.71 Sample. The ensemble, element, item, component, or composite that is conditioned for testing. (See also 3.3.76, Speci¬men.)
3.3.72 Seam. Any permanent attachment of two or more materials in a line formed by joining the separate material pieces.
3.3.73 Shell. A helmet without the suspension system, accesso¬ries, and fittings.
3.3.74* Single-Use Emergency Medical Protective Ensemble.
Multiple elements of compliant protective clothing and equip¬ment providing full body coverage, intended for a single use, that when worn together provide protection from some risks, but not all risks, of emergency medical operations.
3.3.75* Single-Use Item. Items that are designed to be used one time and then disposed of.
3.3.76 Specimen. The conditioned element, item, compo¬nent, or composite that is tested. Specimens are taken from samples. (See also 3.3.71, Sample.)
3.3.77 Splash-Resistant Eyewear. Safety glasses, prescription eyewear with protective side shields, goggles, or chin-length face shields that, when worn properly, provide limited protec¬tion against splashes, spray, spatters, or droplets of body fluids.
3.3.78 Storage Life. The life expectancy of protective clothing and ensemble elements from the date of manufacture when it is only stored and inspected and has undergone proper care and maintenance in accordance with the manufacturer’s instructions, but not used, donned, doffed, or repaired.
3.3.79* Tongue. The part of the protective footwear that is provided for protective footwear with a closure that extends from the vamp to the top line of the footwear between sides of the footwear upper and is exposed to the exterior environment when the footwear is correctly donned.
3.3.80 Trace Number. A code that can be used to retrieve the production history of a product (e.g., a lot or serial number).
3.3.81 Upper. That part of the protective footwear including, but not limited to, the toe, vamp, quarter, shaft, collar, and throat; but not including the sole with heel, puncture-resistant device, and insole.
3.3.82* Visibility Materials. Fluorescent and retroreflective materials used in the construction of garments to provide conspicuity for the purpose of providing both daytime and nighttime visibility of the wearer.
3.3.83 Visor Material. The transparent material that allows the wearer to see outside the protective garment hood.
3.3.84 Wear Surface. A footwear term for the bottom of the sole, including the heel.
3.3.85 Work Glove. An abbreviated term for emergency medi¬cal work glove. (See also 3.3.33, Emergency Medical Work Glove.)
Chapter 4 Certification
4.1 General.
4.1.1 The process of certification for protective ensembles and ensemble elements as being compliant with NFPA 1999 shall meet the requirements of Section 4.1, General; Section 4.2, Certification Program; Section 4.3, Inspection and Testing; Section 4.4, Annual Verification of Product Compliance; Section 4.5, Manufacturers’ Quality Assurance Program; Section 4.6, Hazards Involving Compliant Product; Section 4.7, Manufacturers’ Investigation of Complaints and Returns; and Section 4.8, Manufacturers’ Safety Alert and Product Recall Systems.
4.1.2 All compliant protective clothing items, protective ensembles, and ensemble elements that are labeled as being compliant with this standard shall meet or exceed all applica¬ble requirements specified in this standard and shall be certi¬fied.
4.1.2.1 The certification organization shall permit only the certification of complete single-use and multi-use protective ensembles that include the garments, glove, footwear, and other elements specified in Section 6.7 and Section 6.8 respec¬tively.
4.1.2.2 The certification organization shall further require that the single-use and multi-use protective ensemble manufac¬turer specify the respiratory protection for the ensemble.
4.1.3 All certification shall be performed by a certification organization that meets at least the requirements specified in Section 4.2, Certification Program, and that is accredited for personal protective equipment (PPE) in accordance with ISO 17065, Conformity assessment — Requirements for bodies certifying products, processes, and services. The accreditation shall be issued by an accreditation body operating in accordance with ISO/IEC 17011, Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies.
4.1.4 Manufacturers shall not claim compliance with portions or segments of the requirements of this standard and shall not use the NFPA name or the name or identification of this stand¬ard, NFPA 1999, in any statements about their respective prod¬uces) unless the product(s) is certified as compliant to this standard.
4.1.5 All compliant protective ensembles and ensemble elements shall be labeled.
4.1.6 All compliant protective ensembles and ensemble elements shall be listed by the certification organization. The listing shall uniquely identify the certified product, for exam¬ple, by style, model number, or part number.
4.1.7 All compliant protective ensembles and ensemble elements shall also have a product label that meets the require¬ments specified in Section 5.1, Product Label Requirements for Emergency Medical Protective Clothing Items.
4.1.8* The certification organization’s label, symbol, or identi¬fying mark shall be attached to the product label, shall be part of the product label, or shall be immediately adjacent to the product label.
4.1.9 The certification organization shall not issue any new certifications to the 2013 edition of this standard on or after the NFPA effective date for the 2018 edition, which is August 21, 2017.
4.1.10 The certification organization shall not permit any manufacturer to continue to label any protective clothing items that are certified as compliant with the 2013 edition of this standard on or after August 21, 2018.
4.1.11 The certification organization shall require manufac¬turers to remove all certification labels and product labels indi¬cating compliance with the 2013 edition of this standard from all protective ensembles and ensemble elements that are under the control of the manufacturer on August 21, 2018, and the certification organization shall verify that this action is taken.
4.2 Certification Program.
4.2.1* The certification organization shall not be owned or controlled by manufacturers or vendors of the product being certified.
4.2.2 The certification organization shall be primarily engaged in certification work and shall not have a monetary interest in the product’s ultimate profitability.
4.2.3 The certification organization shall be accredited for PPE in accordance with ISO/IEC 17065, Conformity assessment
— Requirements for bodies certifying products, processes, and services. The accreditation shall be issued by an accreditation body operating in accordance with ISO 17011, Conformity assessment
— General requirements for accreditation bodies accrediting conformity assessment bodies.
4.2.4 The certification organization shall refuse to certify products to this standard that do not comply with all applicable requirements of this standard.
4.2.5* The contractual provisions between the certification organization and the manufacturer shall specify that certifica¬tion is contingent on compliance with all applicable require¬ments of this standard.
4.2.5.1 The certification organization shall not offer or confer any conditional, temporary, or partial certifications.
4.2.5.2 Manufacturers shall not be authorized to use any label or reference to the certification organization on products that are not compliant with all applicable requirements of this standard.
4.2.6 The certification organization shall have laboratory facilities and equipment available for conducting proper tests to determine product compliance.
4.2.6.1 The certification organization laboratory facilities shall have a program in place and functioning for calibration of all instruments, and procedures shall be in use to ensure proper control of all testing.
4.2.6.2 The certification organization laboratory facilities shall follow good practice regarding the use of laboratory manuals, form data sheets, documented calibration and calibration routines, performance verification, proficiency testing, and staff qualification and training programs.
4.2.7 The certification organization shall require the manufac¬turer to establish and maintain a quality assurance program that meets the requirements of Section 4.5, Manufacturer’s Quality Assurance Program.
4.2.7.1* The certification organization shall require the manufacturer to have a product recall system specified in Section 4.8, Manufacturers’ Safety Alert and Product Recall Systems, as part of the manufacturer’s quality assurance program.
4.2.7.2 The certification organization shall audit the manufac¬turer’s quality assurance program to ensure that the quality assurance program provides continued product compliance with this standard.
4.2.8 The certification organization and the manufacturer shall evaluate any changes affecting the form, fit, or function of the compliant product to determine its continued certification to this standard.
4.2.9* The certification organization shall have a follow-up inspection program of the manufacturing facilities of the compliant product with at least two random and unannounced visits per 12-month period.
4.2.9.1 As part of the follow-up inspection program, the certif¬ication organization shall select sample compliant product at random from the manufacturer’s production line, from the manufacturer’s in-house stock, or from the open market.
4.2.9.2 The sample product shall be evaluated by the certifica¬tion organization to verify the product’s continued compliance in order to assure that the materials, components, and manu¬facturing quality assurance systems are consistent with the materials, components, and manufacturing quality assurance that were inspected and tested by the certification organization during certification and recertification.
4.2.9.3 The certification organization shall be permitted to conduct specific testing to verify the product’s continued compliance.
4.2.9.4 For products, components, and materials where prior testing, judgment, and experience of the certification organiza¬tion have shown the result to be in jeopardy of not complying with this standard, the certification organization shall conduct more frequent testing of the sample product, components, and materials acquired in accordance with 4.2.9.1 against the appli¬cable requirements of this standard.
4.2.10 The certification organization shall have in place a series of procedures, as specified in Section 4.6, Hazards Involv¬ing Compliant Product, that address report (s) of situation(s) in which a compliant product is subsequently found to be hazard¬ous.
4.2.11 The certification organization’s operating procedures shall provide a mechanism for the manufacturer to appeal deci¬sions. The procedures shall include the presentation of infor¬mation from both sides of a controversy to a designated appeals panel.
4.2.12 The certification organization shall be in a position to use legal means to protect the integrity of its name and label. The name and label shall be registered and legally defended.
4.3 Inspection and Testing.
4.3.1 For both initial certification and recertification of protective ensembles and ensemble elements, the certification organization shall conduct both inspection and testing as speci¬fied in this section.
4.3.2 All inspections, evaluations, conditioning, and testing for certification or for recertification shall be conducted by a certification organization’s testing laboratory that is accredited in accordance with the requirements of ISO/IEC 17025,
General requirements for the competence of calibration and testing labo¬ratories.
4.3.2.1 The certification organization’s testing laboratory’s scope of accreditation to ISO 17025, General requirements for the competence of testing and calibration laboratories, shall encompass testing of personal protective equipment.
4.3.2.2 The accreditation of a certification organization’s test¬ing laboratory shall be issued by an accreditation body operat¬ing in accordance with ISO/IEC 17011, Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies.
4.3.3 A certification organization shall be permitted to utilize conditioning and testing results conducted by a product or component manufacturer for certification or recertification provided the manufacturer’s testing laboratory meets the requirements specified in 4.3.3.1 through 4.3.3.5.
4.3.3.1 The manufacturer’s testing laboratory shall be accredi¬ted in accordance with the requirements of ISO/IEC 17025,
General requirements for the competence of testing and calibration labo¬ratories.
4.3.3.2 The manufacturer’s testing laboratory’s scope of accreditation to ISO 17025, General requirements for the competence of testing and calibration laboratories, shall encompass testing of personal protective equipment.
4.3.3.3 The accreditation of a manufacturer’s testing labora¬tory shall be issued by an accreditation body operating in accordance with ISO/IEC 17011, Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies.
4.3.3.4 The certification organization shall approve the manu¬facturer’s testing laboratory.
4.3.3.5 The certification organization shall determine the level of supervision and witnessing of the conditioning and test¬ing for certification or recertification conducted at the manu¬facturer’s testing laboratory.
4.3.4 Sampling levels for testing and inspection shall be estab¬lished by the certification organization and the manufacturer to ensure a reasonable and acceptable reliability at a reasona¬ble and acceptable confidence level that products certified to this standard are compliant, unless such sampling levels are specified herein.
4.3.5 Inspection by the certification organization shall include a review of all product labels to ensure that all required label attachments, compliance statements, certification statements, and other product information are at least as specified for the protective clothing element or item.
4.3.6 Inspection by the certification organization shall include an evaluation of any symbols and pictorial representations used on product labels or in user information, as permitted by 5.1.5, to ensure that the symbols are clearly explained in the product’s user information package.
4.3.7 Inspection by the certification organization shall include a review of the user information required by Section 5.2 to ensure that the information has been developed and is availa¬ble.
4.3.8 Inspection by the certification organization for deter¬mining compliance with the design requirements specified in Chapter 6 shall be performed on whole or complete products.
4.3.9 Testing to determine product compliance with the performance requirements specified in Chapter 7 shall be conducted by the certification organization in accordance with the specified testing requirements of Chapter 8.
4.3.9.1 Testing shall be performed on specimens representa¬tive of materials and components used in the actual construc¬tion of the protective ensemble and ensemble element.
4.3.9.2 The certification organization also shall be permitted to use sample materials cut from a representative product.
4.3.10 The certification organization shall not allow any modi¬fications, pretreatment, conditioning, or other such special processes of the product or any product component prior to the product’s submission for evaluation and testing by the certification organization.
4.3.11 The certification organization shall not allow the substi¬tution, repair, or modification, other than as specifically permitted herein, of any product or any product component during testing.
4.3.12 The certification organization shall not allow test speci¬mens that have been conditioned and tested for one method to be reconditioned and tested for another test method unless specifically permitted in the test method.
4.3.13 The certification organization shall test ensemble elements with the specific ensemble(s) with which they are to be certified.
4.3.14 Any change in the design, construction, or material of a compliant product shall necessitate new inspection and testing to verify compliance to all applicable requirements of this standard that the certification organization determines can be affected by such change. This recertification shall be conduc¬ted before labeling the modified product as being compliant with this standard.
4.3.15 The manufacturer shall maintain all design and performance inspection and test data from the certification organization used in the certification of the manufacturer’s compliant product. The manufacturer shall provide such data, upon request, to the purchaser or authority having jurisdiction.
4.4 Annual Verification of Product Compliance.
4.4.1 All individual elements of the protective ensemble that are labeled as being compliant with this standard shall undergo recertification on an annual basis. (See Table 4.4.1.) This recerti¬fication shall include the following:
(1) Inspection and evaluation to all design requirements as required by this standard on all manufacturer models and components
(2) Testing to all performance requirements as required by this standard on all manufacturer models and compo¬nents within the following protocol:
(a) Where a test method incorporates testing both before and after the laundering condition specified in 8.1.3 and the test generates quantitative results, recertification testing shall be limited to the condi¬tioning that yielded the worst case test result during the initial certification for the model or component.
(b) Where a test method incorporates testing both before and after the laundering condition specified in 8.1.3 and the test generates nonquantitative results, recertifications shall be limited to a single conditioning procedure in any given year. Subse¬quent annual recertifications shall cycle through the remaining conditioning procedures to ensure
that all required conditionings are included over time.
(c) Where a test method requires the testing on three specimens, a minimum of one specimen shall be tested for annual recertification.
(d) Where a test method requires the testing of five or more specimens, a minimum of two specimens shall be tested for annual recertification.
4.4.2 Samples of manufacturer models and components for recertification acquired from the manufacturer or component supplier during random and unannounced visits as part of the follow-up inspection program in accordance with 4.2.9 shall be permitted to be used toward annual recertification.
4.4.3 The manufacturer shall maintain all design and performance inspection and test data from the certification organization used in the recertification of manufacturer models and components. The manufacturer shall provide such data, upon request, to the purchaser or authority having juris¬diction.
4.5 Manufacturer’s Quality Assurance Program.
4.5.1 The manufacturer shall provide and operate a quality assurance program that meets the requirements of this section and that includes a product recall system as specified in 4.2.7.1 and Section 4.8, Manufacturers’ Safety Alert and Product Recall Systems.
4.5.2 The operation of the quality assurance program shall evaluate and test compliant product production to the require¬ments of this standard to assure production remains in compli¬ance.
4.5.3* The manufacturer shall be registered to ISO 9001,
Quality management systems — Requirements.
4.5.3.1 Registration to the requirements of ISO 9001, Quality management systems — Requirements, shall be conducted by a registrar that is accredited for personal protective equipment.
4.5.3.2 Where the registrar specified in 4.5.3.1 is currendy accredited for personal protective equipment in accordance with the 1996 edition of ISO Guide 62, General requirements for bodies operating assessment and certification/registration of quality systems, that accreditation shall be permitted until September 14, 2008.
4.5.3.3 Not later than September 14, 2008, registrars specified in 4.5.3.1 shall be accredited for personal protective equipment in accordance with the 2006 edition of ISO/IEC 17021,
Conformity assessment — Requirements for bodies providing audit and certification of management systems.
4.5.3.4 Any new accreditations for registrars specified in 4.5.3.1 for personal protective equipment shall only be in accordance with the 2011 edition of ISO/IEC 17021, Conformity assessment — Requirements for bodies providing audit and certifica¬tion of management systems.
4.5.4* Any entity that meets the definition of manufacturer specified in Section 3.3, General Definitions, and therefore is considered to be the “manufacturer” but does not manufacture or assemble the compliant product, shall meet the require¬ments specified in this section.
4.5.5* Where the manufacturer uses subcontractors in the construction or assembly of the compliant product, the loca¬tions and names of all subcontractor facilities shall be docu¬mented, and the documentation shall be provided to the manufacturer’s ISO registrar and the certification organization.
4.6 Hazards Involving Compliant Product.
4.6.1* The certification organization shall establish proce¬dures to be followed where situation(s) are reported in which a compliant product is subsequently found to be hazardous. These procedures shall comply with the provisions of ISO 27,
Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity, and as modified herein.
4.6.2* Where a report of a hazard involved with a compliant product is received by the certification organization, the valid¬ity of the report shall be investigated.
4.6.3 With respect to a compliant product, a hazard shall be a condition or create a situation that results in exposing life, limb, or property to an imminendy dangerous or dangerous condition.
4.6.4 Where a specific hazard is identified, the determination of the appropriate action for the certification organization and the manufacturer to undertake shall take into consideration the severity of the hazard and its consequences to the safety and health of users.
4.6.5 Where it is established that a hazard is involved with a compliant product, the certification organization shall deter¬mine the scope of the hazard, including products, model numbers, serial numbers, factory production facilities, produc¬tion runs, and quantities involved.
4.6.6 The certification organization’s investigation shall include, but not be limited to, the extent and scope of the problem as it might apply to other compliant products or compliant product components manufactured by other manu¬facturers or certified by other certification organizations.
4.6.7 The certification organization shall also investigate reports of a hazard where a compliant product is gaining wide¬spread use in applications not foreseen when the standard was written, such applications in turn being ones for which the product was not certified, no specific scope of application has been provided in the standard, and no limiting scope of appli¬cation was provided by the manufacturer in written material accompanying the compliant product at the point of sale.
4.6.8 The certification organization shall require the manufac¬turer of the compliant product, or the manufacturer of the compliant product component if applicable, to assist the certifi¬cation organization in the investigation and to conduct its own investigation as specified in Section 4.7, Manufacturers’ Investi¬gation of Complaints and Returns.
4.6.9 Where the facts indicating a need for corrective action are conclusive and the certification organization’s appeal procedures referenced in 4.2.11 have been followed, the certifi¬cation organization shall initiate corrective action immediately, provided there is a manufacturer to be held responsible for such action.
4.6.10 Where the facts are conclusive and corrective action is indicated, but there is no manufacturer to be held responsible, such as when the manufacturer is out of business or the manu¬facturer is bankrupt, the certification organization shall imme¬diately notify relevant governmental and regulatory agencies and issue a notice to the user community about the hazard.
6.1.1.4.2 Where garments are configured as separate hoods, the hood shall cover at least the top, back, and sides of the head.
6.1.1.4.3 Where garments incorporate hoods or are provided as separate hoods, the hood shall be permitted to have a face opening that accommodates the wearing of specific eye and face protection devices or respirators.
6.1.1.4.4 Where garments incorporate hoods or are provided as separate hoods, the hood shall be permitted to include a clear visor that covers the wearer’s eyes and face.
6.1.1.5* All portions of the body covered by the garment item shall be provided with barrier protection.
6.1.1.6* The barrier layer used in the construction of the garment shall be a single, nonseparable layer.
6.1.1.7* All external fittings including, but not limited to, zippers, snaps, or other fasteners of specimen garments shall be examined and shall be free of rough spots, burrs, or sharp edges that could tear the garment or glove materials.
6.1.2 Multiple-Use Emergency Medical Garment Design Requirements.
6.1.2.1 Garments shall be designed to cover any part of the upper and lower torso, excluding hands, face, and feet.
6.1.2.2 Garments shall be permitted to be configured as full body clothing such as jackets and pants or coveralls, and non- full body clothing such as aprons, sleeve protectors, sleeved aprons or smocks, and hoods. (See A.6.1.1.2.)
6.1.2.2.1 Where garments are configured as aprons, garments shall be designed to protect the front torso of the wearer from the neck to below the knees.
6.1.2.2.2 Where garments are configured as sleeve protectors, garments shall be designed to protect the arm of the wearer from the wrist crease to a distance of no less than 405 mm (16 in.) from the wrist crease.
6.1.2.2.3 Where garments are configured as sleeved aprons, garments shall be designed to protect the front torso of the wearer from the neck to below the knees and the arms of the wearer to the wrist crease.
6.1.2.2.4 Where garments are configured as separate hoods, garments shall be designed to protect the wearer at the top, side, and back of the wearer’s head and the wearer’s neck.
6.1.2.3 Garments shall be permitted to include integrated booties to protect the wearer’s feet in conjunction with outer footwear.
6.1.2.3.1 Where garments incorporate booties, the booties shall be designed as an extension of the garment leg and shall cover the entire foot and ankle.
6.1.2.4 Garments shall be permitted to include integrated hoods to protect portions of the wearer’s head and face in conjunction with eye and face protection devices and appropri¬ate respirators.
6.1.2.4.1 Where garments incorporate hoods, the hood shall cover at least the top, back, and sides of the head.
6.1.2.4.2 Where garments are configured as separate hoods, the hood shall cover at least the top, back, and sides of the head.
6.1.2.4.3 Where garments incorporate hoods or are provided as separate hoods, the hood shall be permitted to have a face opening that accommodates the wearing of specific eye and face protection devices.
6.1.2.4.4 Where garments incorporate hoods or are provided as separate hoods, the hood shall be permitted to include a clear visor that covers the wearer’s eyes and face.
6.1.2.5 All portions of the body covered by the garment item shall be provided with barrier protection. (See A. 6.1.1.5.)
6.1.2.6 The barrier layer used in the construction of the garment shall be a single, nonseparable layer. (See A. 6.1.1.6.)
6.1.2.7 All external fittings including, but not limited to, zippers, snaps, or other fasteners of specimen garments shall be examined and shall be free of rough spots, burrs, or sharp edges that could tear the garment or glove materials.
6.1.2.8* Where visibility materials are used on garments, and the garments are intended to be used as high-visibility safety apparel, garments shall meet the respective requirements for Performance Class 1, 2, or 3 in accordance with ANSI/ISEA 107, High-Visibility Safety Apparel and Accessories.
6.2 Emergency Medical Glove Design Requirements.
6.2.1 Single-Use Emergency Medical Examination Glove Design Requirements.
6.2.1.1* Examination gloves shall be designed and designated to meet only the single-use requirements of this standard.
6.2.1.2 In order to label or otherwise represent examination gloves as being compliant with the requirements of this stand¬ard, the manufacturer shall provide gloves in not less than five separate and distinct sizes.
6.2.1.3 Examination gloves shall be permitted to be provided in ambidextrous sizing.
6.2.1.4 Examination glove sizing shall be consistent with EN 455-2, Medical gloves for single use — Part 2: Requirements and test¬ing for physical properties.
6.2.2 Single-Use Emergency Medical Cleaning/Utility Glove Design Requirements.
6.2.2.1 In order to label or otherwise represent cleaning/util¬ity gloves as being compliant with the requirements of this code, the manufacturer shall provide gloves in not less than four separate and distinct sizes.
6.2.2.2 Cleaning/utility glove hand circumference sizing shall be in accordance with Clause 51 of EN 420, General Requirements for Protective Gloves. Requirements for glove length shall be disregarded.
6.2.2.3 Gloves shall have a length of at least 278 mm (11 in.).
6.2.2.4 Cleaning/utility gloves and related hardware shall be examined and shall be free of rough spots, burrs, or sharp edges that could tear garment or glove material.
6.4.1.3.2 The NFPA 1999-compliant footwear item shall be centered inside the footwear cover for determining lateral extension of the footwear cover wear surface.
6.4.1.4 The footwear cover shall have some means to allow the top of the footwear cover to fit snugly around the wearer’s bottom leg.
6.4.2 Multiple-Use Emergency Medical Footwear Design Requirements.
6.4.2.1 Footwear shall be designed and designated to meet only the multiple-use requirements of this standard.
6.4.2.2 Footwear shall consist of an upper with sole and heel.
6.4.2.3 Footwear height shall be a minimum of 100 mm (4 in.) when measured according to 6.4.2.3.1 through 6.4.2.3.4.
6.4.2.3.1 The footwear height shall be determined by measur¬ing inside the footwear from the center of the insole at the heel up to a perpendicular reference line extending across the foot¬wear, at the lowest point of the topline, excluding the tongue and gusset.
6.4.2.3.2 Removable insole inserts shall not be removed prior to measurement.
6.4.2.3.3 Moisture protection shall be continuous circumfer- entially to within 50 mm (2 in.) of the footwear topline at all locations, with the exception of the area inside of and within 13 mm (0.5 in.) around pull-up holes that fully penetrate the footwear from outside to inside. The height of physical and moisture protection at all locations of the boot shall be no less than 100 mm (4 in.) when measured as described in 6.4.2.3.1.
6.4.2.3.4 Physical protection shall be continuous circumferen- tially to within 50 mm (2 in.) of the footwear topline at all loca¬tions, with the exception of the tongue, gusset, and the area inside of and within 13 mm (0.5 in.) around pull-up holes that fully penetrate the footwear from outside to inside. The height of physical protection at all locations of the boot, with the exception of the tongue and gusset, shall be no less than 100 mm (4 in.) when measured as described in 6.4.2.3.1.
6.4.2.4 Footwear shall be available in all of the following sizes:
(1) Men’s 5-13, including half sizes, and a minimum of three widths
(2) Women’s 5-10, including half sizes, and a minimum of three widths
6.4.2.4.1 Manufacturers shall be required to establish and provide, upon request, a size conversion chart for each model or style of protective footwear based on toe length, arch length, and foot width as measured on the Bannock Scientific Foot Measuring Device.
6.4.2.4.2 Full and half sizes, in each of the three required widths, shall be accomplished by individual and unique lasts to provide proper fit.
6.4.2.5 Any permanent attachment provided by the manufac¬turer to footwear shall not interfere with the function of that footwear or with the function of any of the footwear compo¬nent parts.
6.4.2.6 Where footwear is provided by the manufacturer with permanent attachments, the footwear shall meet all of the design and performance requirements of this standard with permanent attachments installed. In all cases, such permanent attachments shall not degrade the performance of the foot¬wear.
6.4.3 Multiple-Use Medical Care Facility Footwear Design Requirements.
6.4.3.1 Footwear shall consist of an upper with sole and heel.
6.4.3.2 Footwear height shall be a minimum of 75 mm (3 in.) when measured according to 6.4.3.2.1 through 6.4.3.2.4.
6.4.3.2.1 The footwear height shall be determined by measur¬ing inside the footwear from the center of the insole at the heel up to a perpendicular reference line extending across the foot¬wear, at the lowest point of the topline, excluding the tongue and gusset.
6.4.3.2.2 Removable insole inserts shall not be removed prior to measurement.
6.4.3.2.3 Moisture protection shall be continuous circumfer- entially to within 50 mm (2 in.) of the footwear topline at all locations, with the exception of the area inside of and within 13 mm (0.5 in.) around pull-up holes that fully penetrate the footwear from outside to inside. The height of physical and moisture protection at all locations of the boot shall be no less than 75 mm (3 in.) when measured as described in 6.4.2.3.1.
6.4.3.2.4 Physical protection shall be continuous circumferen- tially to within 50 mm (2 in.) of the footwear topline at all loca¬tions, with the exception of the tongue, gusset, and the area inside of and within 13 mm (0.5 in.) around pull-up holes that fully penetrate the footwear from outside to inside. The height of physical protection at all locations of the boot, with the exception of the tongue and gusset, shall be no less than 75 mm (3 in.) when measured as described in 6.4.2.3.1.
6.4.3.3 Footwear shall be available in all of the following sizes:
(1) Men’s 5-13, including half sizes, and a minimum of three widths
(2) Women’s 5-10, including half sizes, and a minimum of three widths
6.4.3.3.1 Manufacturers shall be required to establish and provide, upon request, a size conversion chart for each model or style of protective footwear based on the toe length, arch length, and foot width as measured on the Bannock Scientific Foot Measuring Device.
6.4.3.3.2 Full and half sizes, in each of the three required widths, shall be accomplished by individual and unique lasts to provide proper fit.
6.5* Multiple-Use Emergency Medical Helmet Design Require¬ments.
6.5.1 Medical helmets shall be designed and designated to meet only the multiple-use requirements of this standard.
6.5.2 Helmets shall meet the requirements for Type 1, Class G helmets of ANSI/ISEA Z89.1, Standard for Industrial Head Protec¬tion.
6.5.3 Helmets shall be designed to consist of at least a shell with a brim or peak; a means of absorbing energy; a suspension system with a sweatband, chin strap, and nape device; and retroreflective markings.
7.1.2.21.5 Where garment bootie material seams are different from the garment material seams, the garment bootie material seams shall be tested for seam breaking strength in accordance with Section 8.8 and shall have a seam breaking strength of not less than 50 N (11.2 lbf).
7.2 Emergency Medical Glove Performance Requirements.
7.2.1 Single-Use Emergency Medical Examination Glove Performance Requirements.
7.2.1.1 Examination gloves shall be tested for liquidtight integrity as specified in Section 8.9, Liquidtight Integrity Test Two, and shall have an acceptable quality limit of 1.5 or better.
7.2.1.2 Examination gloves shall be tested for body fluid- borne pathogen resistance as specified in Section 8.10, Biope- netration Test Two, and shall exhibit no penetration of the Phi- X174 bacteriophage.
7.2.1.3 Examination glove material shall be tested for tensile strength as specified in Section 8.11, Ultimate Tensile Strength Test, and shall have an ultimate tensile strength of not less than 14 MPa (2000 psi).
7.2.1.4 Examination glove material shall be tested for elonga¬tion as specified in Section 8.12, Ultimate Elongation Test, and shall have an ultimate elongation of not less than 500 percent.
7.2.1.5 Examination glove material shall be tested for punc¬ture resistance as specified in Section 8.13, Puncture Resistance Test One, and shall have a puncture resistance of not less than 4.5 N (1 lbf).
7.2.1.6 Examination gloves shall be tested for dexterity as specified in Section 8.14, Dexterity Test One, and shall have test times no greater than 120 percent of baseline test measure¬ments.
7.2.1.7 Examination glove material shall be tested for protein levels as specified in Section 8.15, Protein Content Test, and shall have protein levels no greater than 50 Hg/g.
7.2.2 Single-Use Emergency Medical Cleaning/Utility Glove Performance Requirements.
7.2.2.1 Cleaning/utility gloves shall be tested for liquidtight integrity as specified in Section 8.9, Liquidtight Integrity Test Two, and shall show no leakage.
7.2.2.2 Cleaning/utility gloves shall be tested for body fluid- borne pathogen resistance as specified in Section 8.10, Biope- netration Test Two, and shall exhibit no penetration of Phi- X174 bacteriophage.
7.2.2.3 Cleaning/utility glove materials shall be tested for permeation resistance as specified in Section 8.24, Chemical Permeation Resistance Test, and shall not have a cumulative permeation of greater than 6 p,g/cm2 for each chemical tested.
7.2.2.4 Cleaning/utility glove materials shall be tested for tensile strength as specified in Section 8.11, Ultimate Tensile Strength Test, and shall have an ultimate tensile strength of greater than 10.3 MPa (1500 psi).
7.2.2.5 Cleaning/utility glove materials shall be tested for puncture resistance as specified in Section 8.13, Puncture Resistance Test One, and shall have a puncture resistance of greater than 9 N (2 lbf).
7.2.2.6 Cleaning/utility gloves shall be tested for resistance to cut as specified in Section 8.18, Cut Resistance Test, and shall have a blade travel distance not less than 20 mm (0.8 in.).
7.2.2.7 Cleaning/utility glove materials shall be tested for abrasion resistance as specified in Section 8.25, Abrasion Resist¬ance Test Two, and shall not show wear-through after 1000 cycles.
7.2.2.8 Cleaning/utility gloves shall be tested for dexterity as specified in Section 8.26, Dexterity Test Two, and shall have an average percent of barehanded control not exceeding 200 percent.
7.2.2.9 Cleaning/utility gloves shall be tested for tactility as specified in Section 8.30, Tactility Test, and shall permit pick-up of pins having a diameter of 5 mm (0.2 in.) or less.
7.2.2.10 Cleaning/utility glove materials shall be tested for flammability as specified in Section 8.35, Flammability Test, and shall have a flame spread time of 3.5 seconds or more.
7.2.3 Multiple-Use Emergency Medical Work Glove Perform¬ance Requirements.
7.2.3.1 Work gloves shall be tested for liquidtight integrity as specified in Section 8.29, Overall Liquid Integrity Test Three, and shall show no water penetration.
7.2.3.2 Work gloves shall be tested for body fluid-borne patho¬gen resistance as specified in Section 8.3, Biopenetration Test One, and shall show no penetration of the Phi-X174 bacterio¬phage.
7.2.3.3 Work glove body materials shall be tested for puncture resistance as specified in Section 8.13, Puncture Resistance Test One, and shall not puncture under an applied force of 9 N (2 lbf).
7.2.3.4 Work glove body and interface component materials shall be tested for resistance to cut as specified in Section 8.18, Cut Resistance Test, and shall have a blade travel distance of not less than 20 mm (0.8 in.).
7.2.3.5 Work glove body composite materials shall be tested for abrasion resistance as specified in Section 8.25, Abrasion Resistance Test Two, and shall show no wear-through.
7.2.3.6 Gloves shall be tested for hand function as specified in Section 8.26, Dexterity Test Two, and shall have an average percent of barehanded control not exceeding 200 percent.
7.2.3.7 Work gloves shall be tested for grip as specified in Section 8.27, Torque Test, and shall have an average percent¬age of bare-handed control not less than 65 percent.
7.2.3.8 Work gloves shall be tested for tactility as specified in Section 8.30, Tactility Test, and shall permit pick-up of pins having a diameter of 8 mm (0.3 in.) or less.
7.2.3.9 All metal hardware and hardware that includes metal parts shall be tested for corrosion resistance as specified in Section 8.22, Corrosion Resistance Test, and shall have metals that are inherendy resistant to corrosion, including, but not limited to, stainless steel, brass, copper, aluminum, and zinc show no more than light surface-type corrosion or oxidation; shall have ferrous metals show no corrosion of the base metal; and shall have hardware items remain functional.
7.2.3.10 Glove body and glove interface component materials shall be tested for flammability as specified in Section 8.35, 8.4.6 Interpretation.
8.4.6.1 Pass/fail performance shall he based on the average tensile strength in the warp and fill directions.
8.4.6.2 A failure in any one direction shall constitute failure for the material.
8.5 Burst Strength Test.
8.5.1 Application.
8.5.1.1 This test shall apply to materials used in the construc¬tion of garments. Where the garment is constructed of several separable layers, each separable layer of garment material shall be tested.
8.5.1.2 Modifications to this test method for testing garment or hood visors shall be as specified in 8.5.7.
8.5.2 Specimens. A total of 10 specimens shall be tested.
8.5.3 Sample Preparation.
8.5.3.1 Samples for conditioning shall be at least 1 m2 (1 yd2) of material.
8.5.3.2 Single-use garment samples shall be conditioned as specified in 8.1.2.
8.5.3.3 Multiple-use garment samples shall be conditioned as specified in 8.1.3 and then conditioned as specified in 8.1.2.
8.5.4 Procedure. Specimens shall be tested in accordance with ASTM D3787, Method for Bursting Strength of Textiles — Constant-Rate-of Traverse (CRT) Ball Burst Test.
8.5.5 Report. The burst strength of each specimen shall be recorded and reported to the nearest 0.5 N (0.1 lbf). The aver¬age burst strength of all specimens shall be calculated and reported.
8.5.6 Interpretation. The average burst strength shall be used to determine pass/fail performance.
8.5.7 Specific Requirements for Testing Garment or Hood Visor Materials. Visor materials that have a thickness greater than 0.25 mm (0.010 in.) when measured in accordance with ASTM D6988, Standard Guide for Determination of Thickness of Plastic Film Test Specimens, shall not be tested.
8.6 Puncture Propagation Tear Resistance Test.
8.6.1 Application.
8.6.1.1 This test shall apply to materials used in the construc¬tion of multiple-use garments. Where the garment is construc¬ted of several separable layers, each separable layer of garment material shall be tested.
8.6.1.2 Modifications to this test method for testing garment or hood visors shall be as specified in 8.5.7.
8.6.2 Specimens. Five specimens in each of the warp and fill directions shall be tested from each sample unit.
8.6.3 Sample Preparation.
8.6.3.1 Samples for conditioning shall be at least 1 m2 (1 yd2) of material.
8.6.3.2 Samples shall be conditioned as specified in 8.1.3 and then conditioned as specified in 8.1.2.
8.6.4 Procedure. Specimens shall be tested in accordance with ASTM D2582, Standard Test Method for Puncture-Propagation Tear Resistance of Plastic Film and Thin Sheeting.
8.6.5 Report.
8.6.5.1 The puncture propagation tear resistance of each specimen shall be recorded and reported to the nearest 0.5 N (0.1 lbf) of force.
8.6.5.2 An average puncture propagation tear resistance shall be calculated and reported for warp and fill directions.
8.6.6 Interpretation.
8.6.6.1 Pass/fail performance shall be based on the average puncture propagation tear resistance in the warp and fill direc¬tions.
8.6.6.2 Failure in any one direction shall constitute failure for the material.
8.6.7 Specific Requirements for Testing Garment or Hood Visor Materials. Visor materials that have a thickness greater than 0.25 mm (0.010 in.) when measured in accordance with ASTM D6988, Standard Guide for Determination of Thickness of Plastic Film Test Specimens, shall not be tested.
8.7 Tear Resistance Test One.
8.7.1 Application. This test shall apply to materials used in the construction of multiple-use garments. Where the garment is constructed of several separable layers, each separable layer of garment material shall be tested.
8.7.2 Specimens.
8.7.2.1 Five specimens in each of the warp and fill directions shall be tested for each material.
8.7.2.2 Specimens shall be prepared in accordance with ASTM D5587, Standard Test Method for the Tearing of Fabrics by Trapezoid Procedure.
8.7.3 Sample Preparation.
8.7.3.1 Samples for conditioning shall be at least 1 m2 (1 yd2) of material.
8.7.3.2 Garment samples shall be conditioned as specified in
8.1.3 and then conditioned as specified in 8.1.2.
8.7.4 Procedure. Specimens shall be tested in accordance with ASTM D5587, Standard Test Method for the Tearing of Fabrics by Trapezoid Procedure.
8.7.5 Report.
8.7.5.1 The tear strength of an individual specimen shall be the average of the five highest peak loads of resistance regis¬tered for mm (in.) of separation of the tear.
8.7.5.2 The tear strength of each specimen shall be recorded and reported to the nearest 0.5 N (0.1 lbf) of force.
8.7.5.3 An average tear strength shall be calculated and repor¬ted for warp and fill directions.
8.7.6 Interpretation.
8.7.6.1 Pass/fail performance shall be based on the average tear strength in the warp and fill directions.
The National Institute for Occupational Safety and Health (NIOSH) tests and approves respirators per 42 CFR 84 for occupational uses. NIOSH-approved disposable respirators are marked with the manufacturer’s name, the part number (P/N), the protection provided by the filter (e.g., N-95), and “NIOSH.” This information is printed on the facepiece, exhala¬tion valve cover, or head straps. A listing of all NIOSH- approved disposable respirators is available at http:// wvvv.cdc.gov/niosh/npptl/topics/respirators/disp_part/. If a disposable respirator does not have these markings and does not appear on one of these lists, it has not been certified by NIOSH. NIOSH also maintains a database of all NIOSH- approved respirators regardless of respirator type, the Certified Equipment List, which can be accessed at http://www.cdc.gov/ niosh/npptl/topics/respirators/disp_part/. In addition, NIOSH provides a Respirator Selection Logic (www.cdc.gov/ niosh/docs/2005-100/default.html), which provides guidance to respirator program administrators on respirator selection. More detailed respirator information has been published by NIOSH, CDC, at http://www.cc.gov/niosh/topics/respirators/ default.html.
Any of the types of particulate respirators can be worn for protection against severe acute respiratory syndrome (SARS), tuberculosis (TB), or avian influenza (bird flu) — if they are NIOSH-approved and if they have been properly fit-tested and maintained. All of the NIOSH-approved particulate respirators protect workers against SARS, TB, and avian influenza as effec¬tively as the N-95 respirators. P-100 respirators should be worn for hazards such as hantavirus.
A respirator will work only if it is used correctly; thus, the key elements for respiratory protection are fit-testing and training of each worker in the use, maintenance, and care of the respi¬rator. NIOSH considers each of the nine types of disposable particulate respirators to have similar fit characteristics. There¬fore, when a worker is caring for or transporting infected patients, having a NIOSH-approved respirator that fits well is much more important than whether the respirator is an N-95 or one of the other eight types of disposable particulate respira¬tors.
In patient care settings, the use of respirators by workers is regulated under the Occupational Safety and Health Adminis¬tration (OSHA) standard for respiratory protection. The OSHA standard sets requirements for the fit-testing of respira¬tors to ensure a proper seal between the respirator’s sealing surface and the wearer’s face. The OSHA standard also contains requirements for determining that workers can use respirators safely, for training and educating employees in the proper use of respirators, and for maintaining respirators prop¬erly. Note: Fit-testing and the other OSHA-required procedures are absolutely essential to assure that the respirator will provide the wearer with required protection. Detailed information on respiratory programs, including fit-test procedures can be found at https://www.osha.gov/pls/oshaweb/
owadisp.show_document?p-table=STANDARDS&pJd=9780. Powered air-purifying respirators (PAPRs) use HEPA filters (high-efficiency particulate air filters), which are as efficient as P-100 filters and will protect against SARS, avian flu, and TB. PAPRs provide a higher level of protection than disposable respirators. Health care facilities in some SARS-affected areas have used higher levels of respiratory protection, including PAPRs, for persons present during aerosol-generating medical procedures such as bronchoscopy on SARS patients. When PAPRs are used, their reusable elements should be cleaned and disinfected after use and the filters replaced in accordance with manufacturer’s recommendations. All used filters should be considered potentially contaminated with infectious material and must be safely discarded.
Design and performance requirements for medical face masks are included in this standard. These items are commonly known as surgical masks. Surgical masks are not designed for use as particulate respirators and do not provide as much protection as an N-95 respirator. Most surgical masks do not effectively filter small particles from air and do not prevent leakage around the edge of the mask when the user inhales.
When a respirator is cleared by the Food and Drug Adminis¬tration (FDA) as a surgical mask and certified by NIOSH as an N-95 respirator mask, the FDA calls it a “surgical N-95 respira¬tor.” Surgical masks and surgical N-95 respirators are regulated by the FDA. The FDA evaluates the performance of these devi¬ces in areas including fluid resistance and filtration efficiency to ensure that they are at least as safe and effective as similar devices already on the market. The FDA encourages manufac¬turers to follow specific performance standards for their masks, and FDA also requires that these products be produced using good manufacturing practices.
Surgical masks and surgical N-95 respirators are disposable devices that cover the mouth and nose during medical proce¬dures. They can help protect the caregiver and patient against microorganisms, body fluids, and small particles in the air, but care should be taken for the selection and use of a surgical mask (medical facemask) versus a surgical N-95 respirator.
Types of Masks and Respirators Used in Patient Care.
(1) Surgical masks.
(a) Include masks labeled as surgical, laser, isolation, dental, or medical procedure
(b) Help protect against microorganisms, body fluids, and large particles in the air
(c) Might be uncomfortable due to tight fit
(d) Are usually packaged as single devices or in boxes of single-use devices
Choosing Between Surgical Masks and Surgical N-95 Respi¬rators.
CDC recommends the use of surgical masks or surgical N-95 respirators based on the ways that specific diseases are transmit¬ted. For more information about CDC recommendations, see Infection Control in Healthcare Settings (www.cdc.gov/ nci dod/ dh q p/ index, h tml).
All NFPA standards on emergency services protective cloth¬ing and equipment require that the item be certified by an independent third-party certification organization and, as with NFPA 1999 emergency medical protective ensembles or protec¬tive clothing items, all items of emergency services protective clothing and equipment must carry the label, symbol, or other identifying mark of that certification organization.
NOTE: Any item of protective clothing or protective equip¬ment covered by an NFPA standard that does not bear the mark of an independent third-party certification organization is not compliant with the appropriate NFPA standard, even if the product label states that the item is compliant!
A.4.2.1 The certification organization should have sufficient breadth of interest and activity so that the loss or award of a specific business contract would not be a determining factor in the financial well-being of the agency.
A.4.2.5 The contractual provisions covering a certification program should contain clauses advising the manufacturer that if requirements change, the product should be brought into compliance with the new requirements by a stated effective date through a compliance review program involving all currently listed products.
Without the clauses, certifiers would not be able to move quickly to protect their name, marks, or reputation. A product safety certification program would be deficient without these contractual provisions and the administrative means to back them up.
A.4.2.7.1 Investigative procedures are important elements of an effective and meaningful product safety certification program. A preliminary review should be carried out on prod¬ucts submitted to the agency before any major testing is under¬taken.
A.4.2.9 Such inspections should include, in most instances, witnessing of production tests. With certain products, the certif¬ication organization inspectors should select samples from the production line and submit them to the main laboratory for countercheck testing. With other products, it could be desira¬ble to purchase samples in the open market for test purposes.
A.4.5.3 In September 2015, a revised edition of ISO 9001, Quality management systems — Requirements, was issued. Both the 2008 and 2015 editions of ISO 9001 are referenced in this edition of NFPA 1999 to allow manufacturers sufficient time to transition their quality management systems registration to this new edition.
A.4.5.4 For example, this situation exists when the product is wholly manufactured and assembled by another entity, or enti¬ties, for a separate entity that puts their own name and label on the product, frequendy called “private labeling,” and markets and sells the product as their product.
A.4.5.5 Subcontractors should be considered to be, but not be limited to, a person or persons, or a company, firm, corpora¬tion, partnership, or other organization having an agreement with or under contract with the compliant product manufac¬turer to supply or assemble the compliant product or portions of the compliant product.
A.4.6.1 ISO Guide 27, Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity, is a component of accreditation of certification organizations speci¬fied in 4.1.3 and 4.2.3. Those paragraphs contain mandatory reference to ISO 17065, Conformity assessment — Requirements for bodies certifying products, processes, and services, in which ISO Guide 27 is referenced.
A.4.6.2 By definition, a hazard could involve a condition that can be imminently dangerous to the end user. With this thought in mind, the investigation should be started immedi¬ately and completed in as timely a manner as is appropriate considering the particulars of the hazard being investigated.
A.4.6.11 The determination of the appropriate corrective action for the certification organization to initiate should take into consideration the severity of the product hazard and its potential consequences to the safety and health of end users. The scope of testing and evaluation should consider, among other things, testing to the requirements of the standard to which the product was listed as compliant; the age, type of use, and conditions to which the compliant product has been exposed; care and maintenance that has been provided; the use of expertise on technical matters outside the certification organization’s area of competence; and product hazards caused by circumstances not anticipated by the requirements of the applicable standard. As a guideline for determining between a safety alert and a product recall, the following product hazard characteristics are provided. These characteristics are based on 42 CFR 84, Subpart E, §84.41:
One specific application has found that the use of specific commercial hand-washing aids, when properly diluted, can be sprayed onto clothing using a hand or paint sprayer. Alterna¬tively, the surrogate contaminant can be brushed or swabbed onto areas of the ensemble that are likely to be contaminated. These procedures identify specific surrogate contaminants and methods of detection that could be adapted for the evaluation of specific ensembles. The procedures could also have utility in training of individuals in proper doffing procedures.
A.5.3.1.1 Purchasers should request that all documentation and performance data be provided in a format that allows easy comparison of products to aid selection. A standard format for reporting certification data allows end user organizations to readily compare products on the basis of required certification data. Certification organizations reviewing compliance of manufacturer technical data packages to the requirements in 5.3.1.1 can allow modifications to the tables to address single- use or multiple-use protective ensembles and ensemble elements with multiple options, such as different external fittings.
A.6.1.1.2 In specifying full body emergency medical protective garments, garments should include the combination of both jacket or coat and pants in order to provide protection to the whole body. Exclusion of the protective pants permits exposure of individuals to hazards associated with emergency medical operations.
A.6.1.1.5 The requirement in 6.1.1.5 is to ensure that an entire garment will provide biopenetration protection for the wearer. In the past, certain parts of a garment, such as the front or the sleeves from wrist to elbows but not above the elbow, were permitted to provide the biopenetration protection, but the purchaser/wearer might not have been aware that the biopenetration protection was only partial.
A.6.1.1.6 The requirement in 6.1.1.6 is not intended to preclude the garment designer/manufacturer from attaching the barrier layer to other garment materials via hemming and binding means in an emergency medical garment.
It is intended that the barrier layer be composed of a single, nonseparable laminate or coated material. It is intended not to allow more than one garment material layer to be designated as and tested as the barrier layer.
The requirement in 6.1.1.6 is also intended to permit evalua¬tion of the barrier layer’s biopenetration resistance.
A.6.1.1.7 The design requirement prevents fittings being used in the construction of garments that could potentially snag or tear protective materials.
A.6.1.2.8 The authority having jurisdiction should conduct a risk assessment and make the determination for the level of visibility required in an ensemble or protective clothing for emergency medical incidents operations, based upon the anticipated use of such garments.
The Federal Highway Administration (FHWA) Manual on Uniform Traffic Control Devices (MITFCD), 2009 edition, requires workers on the right-of-way of all roadways to wear high- visibility apparel that is defined as compliant to ANSI/ISEA 107, High-Visibility Safety Apparel and Headwear, 2010 edition, performance Class 2 or Class 3. It is possible to be compliant with the MUTCD either by incorporating ANSI-compliant high- visibility fluorescent and retroflective materials into NFPA 1999-compliant apparel such as a jacket, parka, shirt, and so on, or through the use of a supplemental high-visibility garment. High-visibility component materials incorporated into primary apparel should comply with the requirements of prevailing standards applying to the chosen ensemble, such as NFPA 1999, ANSI/ISEA 107, and so forth. The MUTCD also allows for the use of garments specified in ANSI/ISEA 207, Standard for High-Visibility Public Safety Vests, as supplemental garments for public safety workers.
In 2015, the International Safety Equipment Association updated ANSI/ISEA 107 combining both ANSI/ISEA 107-2010 and ANSI/ISEA 207-2011 into a single standard, where the former ANSI/ISEA 107 Class 1 performance requirements are considered Type O for off-road and non-roadway use, former ANSI/ISEA 107 Class 2 and 3 performance requirements are now Type R for roadway and temporary traffic control zones, and Type P reflects two classes — Performance Class 2 and Performance Class 3 — for emergency and incident responders and law enforcement personnel. The Type P performance classes in terms of the amount of fluorescent (background) and retroreflective materials are considered the most appropri¬ate for combination with emergency medical protective cloth¬ing.
Users of protective garments should be aware that visibility markings have varying durability under field use conditions. The visibility materials can be damaged but still appear to be in good condition or can become soiled and lose retroreflective or fluorescent qualities. Such visibility markings can also lose retroreflective qualities in rain.
A.6.2.1.1 NFPA 1581 requires single-use emergency medical examination gloves for emergency medical operations.
A.6.2.3.3.7 The measurements given in 6.2.3.3.7(1) through 6.2.3.3.7(5) are palm lengths and are calculated by subtracting the median length of digit 3 from the median hand length found for each glove size.
A.6.3 A variety of different eye and face protection devices exist for first responders and first receivers engaged in emer¬gency medical operations. These devices provide a range of different design characteristics and protective performance. NFPA 1999 addresses three different types of eye and face protection devices. The labeling, design, and performance criteria provided in the standard are intended to provide emer¬gency medical first responders and first receivers with eye and face protective devices that limit the degree to which they can