31
AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, 1:00 p.m. EST Web/Teleconference 1. Roll call of members 2. Self-introductions of guests 3. TC Chair opening remarks – Tricia Hock 4. NFPA process overview – Ken Willette 5. Review of TIA to NFPA 1999 – Jeff Stull 6. Path forward – action items, next meeting 7. Adjourn

AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, …...AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, 1:00 p.m. EST Web/Teleconference 1. Roll call of members 2. Self-introductions

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Page 1: AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, …...AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, 1:00 p.m. EST Web/Teleconference 1. Roll call of members 2. Self-introductions

AGENDA

NFPA 1999 Pre-FD Meeting

November 10, 2014, 1:00 p.m. EST

Web/Teleconference

1. Roll call of members

2. Self-introductions of guests

3. TC Chair opening remarks – Tricia Hock

4. NFPA process overview – Ken Willette

5. Review of TIA to NFPA 1999 – Jeff Stull

6. Path forward – action items, next meeting

7. Adjourn

Page 2: AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, …...AGENDA NFPA 1999 Pre-FD Meeting November 10, 2014, 1:00 p.m. EST Web/Teleconference 1. Roll call of members 2. Self-introductions

Version 3.0, 11-10-2014

1

Proposed Tentative Interim Amendment for NFPA 1999-2013

Proposed Content

3.3.23* Emergency Medical Cleaning/Utility Glove. Multipurpose glove, not for emergency patient

care, that provides a barrier against body fluids, cleaning fluids, and disinfectants and limited physical

protection to the wearer.

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, cerebrospinal fluid, synovial fluid,

sweat, and pericardial fluid.

A.3.3.23 Emergency Medical Cleaning/Utility Glove. Emergency medical cleaning/utility gloves are

not intended to be used as provide an intermediate level of protection between emergency medical

examination gloves or emergency medical work gloves. Emergency medical cleaning/utility gloves are

not intended and should not be used have limited application for emergency patient care because these

gloves might not provide adequate hand function in terms of dexterity and tactility for some medical

tasks. Emergency medical cleaning/utility gloves also do not provide the necessary levels of physical

protection that are met by emergency medical work gloves, which are suitable for extrication and other

emergency medical operations where significant physical hazards might be faced. However, emergency

medical cleaning/utility gloves are more robust and provide greater resistance to physical hazards

compared to emergency medical examination gloves and can be suitable for body recovery and other

medical functions where blood and other body fluids could be encountered outside the provision of

emergency patient care.

3.XX Single-Use Emergency Medical Protective Ensemble. An ensemble consisting of a single-use

emergency medical garment, single-use emergency medical examination gloves, emergency medical

footwear and footwear covers, and emergency medical eye and face protective devices.

A.3.XX Single-Use Emergency Medical Protective Ensemble. [to be developed]

3.XX Multiple-Use Emergency Medical Protective Ensemble. An ensemble consisting of a

multiple-use emergency medical garment, emergency medical cleaning/utility or work glove,

emergency medical footwear and footwear covers, and full facepiece respirator.

A.3.XX Multiple-Use Emergency Medical Protective Ensemble. [to be developed]

5.1.2 Single-Use Emergency Medical Protective Garment and Ensemble Product Label

Requirements.

5.1.2.4 Where the garment is certified as part of a single-use emergency medical protective ensemble, the

following additional language shall be provided.

TO PROVIDE FULL BODY PROTECTION, THE FOLLOWING ADDITIONAL ITEMS MUST

BE WORN AS PART OF THIS ENSEMBLE:

[list items including manufacturer name and model or style number.]

5.1.3 Multiple-Use Emergency Medical Protective Garment and Ensemble Product Label

Requirements.

5.1.3.6 Where the garment is certified as part of a multiple-use emergency medical protective ensemble,

the following additional language shall be provided.

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Version 3.0, 11-10-2014

2

TO PROVIDE FULL BODY PROTECTION, THE FOLLOWING ADDITIONAL ITEMS MUST

BE WORN AS PART OF THIS ENSEMBLE:

[list items including manufacturer name and model or style number.]

5.2.3 The following additional instructions and information shall be provided for single-use and multiple-

use emergency medical protective ensembles:

(1) The specific sequence and requirements for donning each item of the ensemble.

(2) Specific recommended methods for cleaning each item if items are combined or attached and provided

as part of an ensemble.

(3) Specific considerations for decontamination to be employed during the doffing of ensemble items.

(4) The specific sequence, precautions, and requirements for doffing each item of the ensemble, when

contaminated with body fluids, for the avoidance of cross-contamination of the individual wearer, other

ensemble items, and the outside environment.

6.1.1.8 Where the garment is certified as part of a single-use emergency medical protective ensemble, the

manufacturer shall specify the use of specific single-use emergency medical examination gloves (2 pairs –

inner and outer), emergency medical footwear, and emergency medical eye and face protective devices to

meet the requirement in 7.1.1.1.

6.1.2.9 Where the garment is certified as part of a multiple-use emergency medical protective ensemble,

the manufacturer shall specify the use of specific emergency medical cleaning/utility or work gloves worn

over single-use medical emergency examination gloves, emergency medical footwear and covers, and

multiple-use emergency medical eye and full face piece respirators to meet the requirement in 7.1.2.1.

6.3.1.6 Facemasks shall be permitted to be NIOSH certified as filtering facepieces in accordance with

Title 42, Code of Federal Regulations, Part 84, “Approval of Respiratory Protective Devices.”

6.3.3.7 Eye and face protection devices shall be respirators that provide eye and face protection and shall

be permitted to be NIOSH certified as either full facepiece air-purifying respirator with minimum

protection level of P100 or an appropriate tight or loose fitting NIOSH approved powered air-purifying

respirator with a protection level of HE. All respirators shall be approved in accordance with Title 42,

Code of Federal Regulations, Part 84, “Approval of Respiratory Protective Devices.”

7.1.1.1 Full body or full torso garments, including, but not limited to, ensembles, coveralls, coats, jackets,

pants, and overalls, shall be tested for liquidtight integrity as specified in Section 8.2, Liquidtight Integrity

Test One, and shall allow no water penetration.

7.1.2.1 Garments or ensembles shall be tested for liquidtight integrity as specified in Section 8.2,

Liquidtight Integrity Test One, and shall allow no water penetration.

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 106 120 percent of baseline test measurements.

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 10 9 N (2.3 2 lbf).

7.2.2.7 Cleaning/utility glove materials shall be tested for abrasion resistance as specified in Section 8.25,

Abrasion Resistance Test Two, and shall not show wear-through after 1000 100 cycles.

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 have a puncture resistance of greater than 22 9 N (5 2 lbf).

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Version 3.0, 11-10-2014

3

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 not show wear-through after 100 cycles.

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 170 200 percent.

8.1.3.7.1 Garments that are intended to be part of an ensemble shall be washed and dried for a total of 10

washings and 10 drying cycles.

8.1.4 Flexural Fatigue Procedure for Gloves. Sample gloves shall be subjected to one full cycle of

testing for dexterity testing as specified in Section 8.14 for emergency medical examination gloves and as

specified in Section 8.27 for emergency medical cleaning/utility gloves donned on an individual with a

hand size corresponding to the glove and the test subject shall flex the gloves in a complete fist closing

motion every 3 seconds for a total of 100 times for each glove.

8.2.2.3 Where ensembles are tested, specimens shall include all items that are specified as part of the

ensemble in 6.1.1.8 or 6.1.2.9.

8.2.3.1 Samples for conditioning shall be complete garments or ensembles.

8.2.3.2 Single-use garment and ensemble samples shall be conditioned as specified in 8.1.2.

8.2.3.3 Multiple-use ensemble garment and ensemble samples shall be conditioned as specified in 8.1.3

and then conditioned as specified in 8.1.2. All other ensemble elements shall be conditioned as specified

in 8.1.2.

8.2.4.2 In the testing of garments, the mannequin used in testing shall have straight arms and legs, with

the arms positioned downward at the mannequin’s side.

8.2.4.3 In the testing of ensembles, the mannequin used in testing shall have a straight legs, a straight

right arm positioned downward at the mannequin’s side, and a bent left arm, with the left arm bent

upward at 135 degree angle at the elbow from the mannequin’s side.

8.2.5.4 For single-use garments and ensembles, the suited mannequin shall be exposed to the liquid spray

for a total of 8 4 minutes — 2 1 minutes in each of the four specified mannequin orientations. For

multiple-use garments and ensembles the suited mannequin shall be tested for a total of 8 minutes with 2

minutes in each of the four specified mannequin orientations.

8.18.7.2 Cut resistance testing shall be performed under a load of 25 75 g (0.9 2.5 oz).

8.18.8.3 Cut resistance testing shall be performed under a load of 150 75 g (5.3 2.5 oz).

Delete current Section 8.24.1 through 8.24.7 and replace with:

8.24 Chemical Permeation Resistance Test.

8.24.1 Application. This test method shall apply to cleaning/utility glove materials.

8.24.2 Specimens. A minimum of three specimens shall be tested.

8.24.3 Sample Preparation. Specimens shall be conditioned as specified in 8.1.2.

8.24.4 Procedure.

8.24.4.1 Permeation resistance shall be measured in accordance with ASTM F 739a, Standard Test

Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under

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Version 3.0, 11-10-2014

4

Conditions of Continuous Contact, at 25°C, ±2°C (77°F, ±3°F), using the following test parameters and

modifications:

(1) A test duration of 1 hour shall be used.

(2) The test shall be done in the closed loop configuration, using distilled water as the collection medium.

(3) The selected method of detection shall have a sensitivity for measuring a cumulative permeation of

0.1 μg/cm2 over the 1-hour test period. The actual sensitivity of the selected method of detection shall be

determined.

(4) The total cumulative permeation over 1 hour shall be measured in lieu of breakthrough time and

permeation rate.

8.24.2 Permeation resistance shall be separately evaluated against the following chemicals:

(1) 40 percent weight-for-weight (w/w) solution of glutaraldehyde

(2) 70 percent w/w isopropanol

(3) 5 percent solution of sodium hypochlorite

(4) 30 percent w/w hydrogen peroxide

Renumber current 8.24.8 and 8.24.9 as 8.24.5 and 8.24.6, respectively.

8.25.7 Specific Requirements for Testing Cleaning/Utility Gloves. Testing shall be conducted under a

load of 500 g, and specimens shall be examined after 1000 100 cycles.

8.25.8.2 Testing shall be conducted under a load of 500 g, and specimens shall be examined after 1000

100 cycles.

Technical Merit

The outbreak of Ebola Virus Disease (EVD) and escalation of civilian deaths in West Africa has heighted

the potential for a possible epidemic reaching other parts of the world including the United States. While

it is unknown how many cases of EVD will occur domestically until the disease is fully contained, the

current situation has demonstrated that the United States is not as fully prepared as it should be for

confronting highly deadly liquid-borne pathogens among its population. First response organizations,

including EMS personnel, law enforcement officers, and firefighters, as well as especially medical first

receivers will be and have been in contact with potentially infected persons.

Specific recommendations for the selection and use of personal protective equipment (PPE) have been

provided by several organizations including the Center for Disease Control (CDC), World Health

Organization, and Doctors without Borders. The majority of PPE guidance has focused on healthcare

workers with the most recent guidance from CDC requiring (1) repeated training and demonstrated

competency for healthcare workers in the wearing and use of PPE, (2) selection of PPE so that no skin is

exposed, and (3) supervised donning and doffing of PPE. Further details are provided in this guidance for

PPE selection, donning, and doffing procedures. This guidance is found at:

http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html

In addition, CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)

have prepared the “Detailed Emergency Medical Services (EMS) Checklist for Ebola Preparedness,”

found at:

http://www.cdc.gov/vhf/ebola/pdf/ems-checklist-ebola-preparedness.pdf

This checklist identifies basic types of personal protective equipment that first responder [EMS]

organizations should have on hand as part of a preparedness and response program. The CDC recognizes

EMS personnel as any first responder including but not limited to law enforcement, fire services and

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Version 3.0, 11-10-2014

5

HAZMAT teams. In this checklist, CDC and ASPR acknowledge the Interagency Board for Equipment

Standardization and Interoperatbility (IAB). To meet the specific needs of first response organizations,

the IAB provided detailed recommendations for PPE in a document release 24 October 2014:

https://iab.gov/Uploads/IAB%20Ebola%20PPE%20Recommendations_10%2024%2014.pdf

Consistent with its practice, the IAB attempted to define PPE in terms of meeting national consensus

standards. While the IAB recognized that NFPA 1999 is properly positioned in its overall criteria for

establish both material/seam biopenetration resistance and overall liquid integrity consistent with the

threats presented by the current and potential future epidemics, it noted that there as a lack of certified

products that are currently certified to NFPA 1999.

The appropriateness of PPE against EVD and other similar highly infectious pathogens is also predicated

on providing ensembles of PPE items that are properly integrated for full body protection that do not

leave exposed skin. Specific design requirements or methods of making this performance assessment are

not currently specified in NFPA 1999 for the creation of ensembles as specified by the IAB. The reliance

on taping and other means to protect workers leads to highly varied protection levels and can interfere

with the doffing of contaminated ensembles.

The majority of proposed changes to NFPA 1999 define specific ensembles that tie individual clothing

items together for providing full body protection for first responders and apply an integrity evaluation to

demonstrate the level of performance. Specific references have also been made to define appropriate

respiratory protection device that has been defined by the IAB to complete specific ensembles.

It has been further noted that some portions of NFPA 1999 create conflicting requirements or cannot be

adequately implemented for defining appropriate PPE for protection against liquidborne pathogens for

certain items. Additional changes, specifically those for cleaning/utility gloves provide modifications to

test methods and criteria, have been proposed to overcome these current deficiencies, which in turn will

permit the certification of these items and their inclusion as part of complete ensembles.

Emergency Nature

There is an extreme urgency for modifying and correcting NFPA 1999 to address the current PPE needs

of first responders and medical first receivers against EVD and future outbreaks for highly infectious

pathogenic diseases. NFPA 1999 was originally created to deal with the threat of HIV and Hepatitis

Viruses. While it establishes appropriate levels of material/seam biopenetration resistance and overall

liquid integrity, the development and prior revisions of this standard did not anticipate the specific

additional protection needs posed by highly virulent transmissible disease, which can be encountered by

first responders and medical first receivers, for which the standard is intended. The required approach

demands an integrated ensemble of certified items that can be combined to provide full body protection.

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1

Comparison of Performance Criteria for Biological Protective Clothing in NFPA 1994 and NFPA 1999

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Overall Ensemble or Garment Performance

Liquid-tight

integrity (suits)

ASTM F 1359 Visible leakage

inside suit and on

inner liquid-

absorptive garment

Garment only:

None after 8 min

as determined by

examining liquid

absorptive garment

(7.1.1.1)

Garment only:

Same as NFPA

1999-2013 single

use garments but

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.1)

Full ensemble:

Same as NFPA

1999-2013

multiple use

garments (7.6.2)

Particle inward

leakage

NFPA Test

Protocol

Observed particle

leakage on interior

black garment

Full ensemble: No

particle leakage

permitted (7.3.1.1)

Full ensemble: No

particle leakage

permitted after 25

wash cycles of

garment using

washer/ extractor

(7.6.1)

Overall function ASTM F 1154

Completion of

specified tasks

≤ 15 minutes

(7.3.1.2)

Accommodation of

ANSI Class G

Type I helmet

Permits wearing

(7.3.1.2.1)

Visual acuity

through visor and

respirator

facepiece

20/35 or better

(7.3.1.2.2)

Closure integrity Closure flap stays

closed (7.3.1.2.3)

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2

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

High visibility

performance

ANSI 107 Classification of

product

Where provided,

high visibility

products meet

classification of

ANSI 107 and

materials tested for

fluorescence and

retroreflectivity

(7.1.2.12/7.1.2.13)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

External fitting pull

out strength

NFPA Test

Protocol

Force at failure 1000 N or 225

lbf (7.3.1.3)

Exhaust value

inward leakage

NFPA Test

Protocol

Flowrate during

leakage

30 m//min

(7.3.1.5)

Exhaust value

mounting strength

NFPA Test

Protocol

Force required to

separate valve

from suit wall

135 N or 30 lbf

(7.3.1 4)

Hardware corrosion

resistance

ASTM B 117 Observation of

corrosion

No more than light

surface corrosion

for non-ferrous

metals and

corrosion of base

metal for ferrous

hardware

(7.1.2.11)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

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3

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Label durability and

legibility

NFPA Test

Protocol

ASTM D 4966

Label legibility Label remains in

place and legible

after both 25 wash

cycles of garment

using washer/

extractor and

abrasion (7.1.2.10)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Garment Material Performance

Biopenetration

resistance

ASTM F 1671

(also ASTM

F392 and ASTM

F4157 for NFPA

1994)

Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 (7.1.1.2)

Same as NFPA

1999-2013 single

use garments but

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.2)

No penetration of

Bacteriophage Phi-

X174 following

100 flexing cycles

and 10 abrasion

cycles (7.1.1.2)

No penetration of

Bacteriophage Phi-

X174 following 50

cycles of

laundering, 3000

flexing cycles, and

3,000 cycles of

abrasion on

material samples

(7.6.3)

Tensile strength ASTM D5034 Breaking strength 50 N or 11.2 lbf

(7.1.1.3)

222.5 N or 50 lbf

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.3)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Burst strength ASTM D 751 Burst force 66 N or 14.9 lbf

(7.1.1.4)

222.5 N or 50 lbf

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.4)

135 N or 30 lbf

(7.3.2.2)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

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4

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Puncture

propagation tear

resistance

ASTM D 2582 Tear force 12 N or 2.7 lbf

(7.1.1.5)

25 N or 5.5 lbf

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.5)

25 N or 5.6 lbf

(7.3.2.3)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Tear resistance ASTM D 5587 Tear force 17 N or 3.8 lbf

(7.1.1.6)

50 N or 11.2 lbf

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.6)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Cold temperature

performance

ASTM D 747

(modified)

Bending moment

at -25oC (13

oF)

0.68 N x m or

0.5 in.-lbf (7.3.2.4)

Water absorption

resistance

AATCC 42

(modified)

Percent water

absorption

≤ 30% after 25

wash cycles of

garment using

washer/ extractor

(7.1.2.8)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Total heat loss ASTM F 1868 Total heat loss ≥ 450 W/m2

(7.1.1.8)

Same as NFPA

1999-2013 single

use garments

(7.1.2.9);

laundering not

required

Same as NFPA

1999-2013 single

use garments

(7.3.2.5)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Flammability ASTM D 1230

(modified)

Flame spread time ≤ 3.5 sec after 25

wash cycles of

garment using

washer/ extractor

(7.1.2.14)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

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5

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Garment Seam Performance

Biopenetration

resistance

ASTM F 1671 Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 (7.1.1.2)

Same as NFPA

1999-2013 single

use garments but

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.2)

No penetration of

Bacteriophage Phi-

X174 (7.2.2.7)

No penetration of

Bacteriophage Phi-

X174 following 50

cycles of

laundering and

flexing (7.6.3)

Seam strength ASTM D 1683

(NFPA 1999)

ASTM D 751

(NFPA 1994)

Force to separate

seam

50 N or 11.2 lbf

(7.1.1.7)

222.5 N or 50 lbf

after 25 wash

cycles of garment

using washer/

extractor (7.1.2.7)

1.31 kN/m or 15

lbf/2 in (7.1.8.2)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Garment Closure Performance

Closure strength ASTM D 751 Force to separate

closure

1.31 kN/m or 15

lbf/2 in. (7.3.2.7)

Fastener tape

breaking strength

A-A-55126B

ASTM D 5034

Breaking strength Meet or exceed

breaking strength

requirements for

Type 2, Class 1

and 4 tapes

(7.1.2.15)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Fastener tape shear

strength

A-A-55126B

AATCC 61

ASTM D 5170

Shear strength Meet or exceed

shear strength

requirements for

Type 2, Class 1

and 4 tapes after 3

cycles of washing

(7.1.2.16)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

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6

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Fastener tape peel

strength

A-A-55126B

AATCC 61

ASTM D 5169

Peel strength Meet or exceed

peel strength

requirements for

Type 2, Class 1

and 4 tapes after 3

cycles of washing

(7.1.2.17)

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Zipper crosswise

breaking strength

A-A55634A Breaking strength A-A-55634A

referenced without

requirements

Same as NFPA

1999-2013

multiple use

garments (7.6.4)

Visor Material Performance

Biopenetration

resistance

ASTM F 1671 Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 (7.3.2.8.1)

Burst strength ASTM D 751 Burst force 135 N or 30 lbf

(7.3.2.8.2)

Puncture

propagation tear

resistance

ASTM D 2582 Tear force 25 N or 5.5 lbf

(7.3.2.8.3)

Cold temperature

performance

ASTM D 2136

(modified)

Embrittlement

behavior

No cracking or

evidence of visible

damage (7.3.2.8.4)

Visor Seam Performance

Biopenetration

resistance

ASTM F 1671 Detection of virus

in assay

Missing

requirement

Seam strength ASTM D 751 Force to separate

seam

1.31 kN/m or 15

lbf/2 in. (7.3.2.8.5)

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7

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

NFPA 1999-2013

Single Use

Medical

Facemasks or

Eye/Face

Protection

Devices

NFPA 1999-2003

Multiple Use

Eye/Face

Protection

Devices or Face

Protection

Devices

Blood penetration

resistance

ASTM F 2100 Classification Meet barrier

performance class

(7.3.1.1) –

facemasks only

Meet barrier

performance class

(7.3.4.1) – face

protection devices

only

Liquid tight

integrity

ASTM F 1862 Visible synthetic

blood strike

through

No strike through

(7.3.1.2/7.3.2.3)

No strike through

(7.3.3.1/7.3.4.2)

Visual acuity/

fogging resistance

NFPA Test

Protocol

Measured visual

acuity

20/20 or better

(7.3.1.3/7.3.2.5)

20/20 or better

(7.3.3.2) – multiple

use eye/face

protection devices

only

Biopenetration

resistance

ASTM F 1671 Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 (7.3.2.2) –

Eye/face

protection devices

only

No penetration of

Bacteriophage Phi-

X174 (7.3.4.3) –

Face protection

devices only

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8

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

NFPA 1999-2013

Single Use

Medical

Facemasks or

Eye/Face

Protection

Devices

NFPA 1999-2003

Multiple Use

Eye/Face

Protection

Devices or Face

Protection

Devices

Device hood

materials

Various test

methods

Different material

performance

criteria

Meet requirements

for NFPA 1999-

2013 single use

garments (7.3.2.4)

– Eye/face

protection devices

only

Flammability ASTM D 1230

(modified)

Flame spread time ≤ 3.5 sec (7.3.2.6)

– Eye/face

protection devices

only

≤ 3.5 sec (7.3.4.4)

– Face protection

devices only

Hardware corrosion

resistance

ASTM B 117 Observation of

corrosion

No more than light

surface corrosion

for non-ferrous

metals and

corrosion of base

metal for ferrous

hardware (7.3.3.3/

7.3.4.5)

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9

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Overall Glove Performance

NFPA 1999-2013

Single Use

Examination

Gloves

NFPA 1999-2013

Cleaning/Utility

Gloves

NFPA 1999-2013

Work Gloves

Liquid-tight

integrity (gloves)

ASTM D 5151

(modified)

Visible leakage Have acceptable

quality limit

(AQL) of 1.5 or

better (7.2.1.1)

No visible leakage

(7.2.2.1)

No visible leakage

(7.3.3.1)

Overall

biopenetration

resistance

ASTM F 1671

(modified)

Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 (7.2.1.2)

No penetration of

Bacteriophage Phi-

X174 (7.2.2.2)

Dexterity (fine

hand)

NFPA Test

Protocol

Percentage

increase in test

time over

barehanded tests

≤ 106% (7.2.1.7) 200% (7.3.3.6)

Dexterity (gross

motor) – hand

function

ASTM F 2010 Percentage

increase in test

time over

barehanded tests

≤ 200% (7.2.2.8) ≤ 200% (7.3.3.6) ≤ 170% (7.2.3.6)

Tactility EN 420 Diameter of pin

that can be picked

up and grasped

≥ 2.5 mm (7.2.2.9) ≥ 5 mm (7.2.3.9)

Grip NFPA Test

Protocol

Percentage change

in gripping

strength over

barehanded tests

≥ 80% (7.2.3.7)

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10

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

NFPA 1999-2013

Single Use

Examination

Gloves

NFPA 1999-2013

Cleaning/Utility

Gloves

NFPA 1999-2013

Work Gloves

Glove donning NFPA Test

Protocol

Donning time ≤ baseline + 10 sec

– dry; ≤ baseline +

20 sec – wet

(7.2.3.8)

Label durability and

legibility

NFPA Test

Protocol

Label legibility Label remains

legible after 10

wash cycles using

washer/extractor

and abrasion

(7.2.3.13)

Hardware corrosion

resistance

ASTM B 117 Observation of

corrosion

No more than light

surface corrosion

for non-ferrous

metals and

corrosion of base

metal for ferrous

hardware

(7.2.3.10)

Glove Material Performance

Biopenetration

resistance (material

and seams)

ASTM F 1671 Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 after

repeated flexing

(7.3.3.2)

No penetration of

Bacteriophage Phi-

X174 after 10

wash cycles and

3000 flex cycles

(7.6.3)

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11

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

NFPA 1999-2013

Single Use

Examination

Gloves

NFPA 1999-2013

Cleaning/Utility

Gloves

NFPA 1999-2013

Work Gloves

Permeation

resistance

NFPA Test

Protocol

Cumulative

permeation

≤ 6.0 μg/cm2 when

measured for 40%

glutaraldehyde,

70% isopropanol,

5% sodium hypo-

chloride, and 30%

hydrogen peroxide

(7.2.2.3)

Ultimate tensile

strength

ASTM D 412 Tensile strength ≥ 14 MPa or 2000

psi (7.2.1.3)

≥ 12.5 MPa or

1813 psi (7.2.2.4)

Ultimate elongation ASTM D 412 Elongation ≥ 500% (7.2.1.4)

Puncture resistance ASTM F 1342 Puncture force 4.5 N or 1 lbf

(7.2.1.5)

10 N or 2.3 lbf

(7.2.2.5)

11 N or 2.5 lbf

(7.3.3.4)

22 N or 5 lbf

(7.2.3.3)

Cut resistance ASTM F 1790 Distance of blade

travel

20 mm under

load of 25 grams

(7.2.2.6)

20 mm under

load of 75 grams

(7.3.3.3)

20 mm under

load of 150 grams

(7.2.3.4)

Abrasion resistance ASTM D 3884 Cycles to wear

through

≤ 1000 (7.2.2.7) ≤ 1000 (7.2.3.5)

Protein content ASTM D 5712 Protein

concentration

≤ 50 μg/g (7.2.1.7)

Flammability ASTM D 1230

(modified)

Flame spread time ≤ 3.5 sec (7.2.2.10) ≤ 3.5 sec (7.2.3.11)

Cold temperature

performance

ASTM D 747

(modified)

Bending moment

at -25oC (13

oF)

0.057 N x m or

0.5 in.-lbf (7.3.3.5)

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12

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Overall Footwear Performance

NFPA 1999-2013

Single Use

Footwear Covers

NFPA 1999-2013

Multiple Use

Footwear

Liquid-tight

integrity (footwear)

ASTM D 5151

(modified)

Visible leakage on

inner liquid-

absorptive cover

No visible leakage

after 100,000

footwear flex

cycles (7.4.2.8)

No visible leakage

after 100,000

footwear flex

cycles (7.3.4.1)

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Label durability and

legibility

NFPA Test

Protocol

ASTM D 4966

Label legibility Label remains

legible after 200

abrasion cycles

(7.4.2.9)

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Eyelet and study

attachment strength

NFPA Test

Protocol

Detachment force ≥ 295 N or 66 lbf

(7.4.2.5)

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Hardware corrosion

resistance

ASTM B 117 Observation of

corrosion

No more than light

surface corrosion

for non-ferrous

metals and

corrosion of base

metal for ferrous

hardware (7.4.2.6)

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

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13

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

Footwear Material Performance

NFPA 1999-2013

Single Use

Footwear Covers

NFPA 1999-2013

Multiple Use

Footwear

Biopenetration

resistance (upper

and seams)

ASTM F 1671 Detection of virus

in assay

No penetration of

Bacteriophage Phi-

X174 (7.4.1.1)

No penetration of

Bacteriophage Phi-

X174 (7.4.2.7)

No penetration of

Bacteriophage Phi-

X174 after

100,000 flex

cycles and10

abrasion cycles

(7.3.4.2)

No penetration of

Bacteriophage Phi-

X174 after

500,000 flex

cycles and 60,000

abrasion cycles

(7.6.3)

Cut resistance

(upper)

ASTM F 1790 Distance of blade

travel

20 mm under

load of 350 grams

(7.4.2.1)

Same as NFPA

1999-2013

multiple use

footwear (7.3.4.3)

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Tensile strength ASTM D 5034 Breaking strength ≥ 50 N or 11.2 lbf

(7.4.1.2)

Burst strength ASTM D 751 Burst force ≥ 66 N or 14.9 lbf

(7.4.1.3)

Tear resistance ASTM D 5733 Tear force ≥ 50 N or 11.2 lbf

(7.4.1.4)

Seam strength ASTM D 1683 Breaking strength ≥ 50 N or 11.2 lbf

(7.4.1.5)

Puncture resistance

(wear surface or

upper)

ASTM F 1342 Puncture force 8 N or 1.8 lbf

force – wear

surface (7.4.1.7)

45 N or 10 lbf

force – upper

(7.4.4.2)

36 N or 8 lbf -

upper (7.3.4.4)

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

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V1-5, 10/24/14 1

Recommendations on Selection and Use of Personal Protective Equipment for First Responders

against Ebola Exposure Hazards

I. Background

On 20 October 2014, the U.S. Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) released “Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing).” The most current guidance is available at:

http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html This new guidance is based on observations of Personal Protective Equipment (PPE) practices specifically in hospitals and includes updated requirements for (1) repeated training and demonstrated competency for healthcare workers in the wearing and use of PPE, (2) selection of PPE so that no skin is exposed, and (3) supervised donning and doffing of PPE. Further details are provided in this guidance for PPE selection, donning, and doffing procedures.

In addition, the CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) have prepared the “Detailed Emergency Medical Services (EMS) Checklist for Ebola Preparedness,” found at:

http://www.cdc.gov/vhf/ebola/pdf/ems-checklist-ebola-preparedness.pdf This checklist identifies basic types of PPE that first responder organizations (Emergency Medical Services [EMS]) should have on hand as part of their preparedness and response programs. The CDC

The InterAgency Board for Equipment Standardization and Interoperability (IAB) is a voluntary collaborative panel of emergency preparedness and response practitioners from a wide array of professional disciplines that represent all levels of government and the public safety sector. Based on direct field experience, IAB members advocate for and assist the development and implementation of performance criteria, standards, test protocols, and technical, operating, and training requirements for all-hazards incident response equipment with a special emphasis on Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) issues.

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V1-5, 10/24/14 2

recognizes EMS personnel as any first responder including but not limited to law enforcement, fire services, and hazardous material teams. In this checklist, CDC and ASPR acknowledge the InterAgency Board (IAB) (see panel at bottom of previous page) as a source for additional information on nationally-recognized standards on appropriate PPE for protecting first responder (EMS) personnel from exposure to Ebola.

Recommendations for “EMS and Medical First Responders, Including Firefighters and Law Enforcement Personnel” are also provided in CDC guidance entitled “Interim Guidance for Emergency Medical Services (EMS) Systems and 9-1-1 Public Safety Answering Points (PSAPs) for Management of Patients with Known or Suspected Ebola Virus Disease in the United States.” The link for this guidance is:

http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-emergency-medical-services-systems-911-public-safety-answering-points-management-patients-known-suspected-united-states.html

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V1-5, 10/24/14 3

II. Approach

A. Selection The IAB recommends applying standard specifications, design attributes, test methods and performance criteria when selecting PPE for first responders who may encounter Ebola Virus exposure hazards. These recommendations are intended to complement and supplement information provided by the CDC and ASPR, enabling responder organizations to make effective procurement and deployment choices addressing a wide range of missions, response environments, and varied work conditions.

Figure II-1 provides recommendations for PPE protection levels for EMS personnel based upon a threat level determined by two major factors: the PPE wearer’s possible exposure to Ebola, and proximity to

symptomatic patients. This combination is further defined in CDC guidance.1 The following definitions are used:

(Patient’s) Ebola Exposure Level

Definition

Known or Suspected Exposure

Known disease, known contact with Ebola patient or travel within 21 days to an area with current Ebola cases.

Possible Exposure Environmental or interpersonal exposure in an area with suspect or recent cases except as outlined in top box.

No Known Exposure No known exposure to Ebola Virus Disease patients or travel to areas with known outbreak of the disease.

Symptoms Presented Definition

Asymptomatic No symptoms relevant to an infectious disease.

Fever Measured temperature ≥ 100.4 F

Body Fluids Patient has fever with vomiting, diarrhea, blood in vomitus and/or feces, is incontinent of urine or stool, or is sweating, salivating, or otherwise producing blood and body fluids to which emergency responders could be exposed.

1 See http://www.cdc.gov/vhf/ebola/hcp/case-definition.html

Personal protective equipment alone is not sufficient to ensure protection from Ebola Virus Disease. Each organization has the responsibility to conduct its own risk assessment to determine the appropriate PPE for its individual members. In addition, each organization must develop specific standard operating procedures related to the selection, use (including proper donning and doffing), and care (decontamination, possible reuse or disposal) of PPE, and repeatedly train its members in these procedures.

WARNING

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V1-5, 10/24/14 4

These two factors combine to produce one of three possible recommended PPE levels:

SOP-Recommended PPE, which corresponds to the PPE dictated by the Standard Operating Procedure of the organization, as dictated by CDC guidance and the state/local jurisdiction

Low Risk2 PPE, an increased protection level corresponding to increased likelihood of responder or healthcare worker exposure

High Risk PPE, the highest recommended protection level, corresponding to high likelihood of responder exposure

Each organization should determine the threat level—as shown in the table above—based on an assessment of the specific mission responsibilities and work environment that account for the specific exposure hazards present with their likelihood of member exposure. This risk assessment should consider:

The amount and reliability of information on which the potential Ebola Virus Disease of an individual is based

The expected proximity of the first responder to affected individuals

The duration for which the first responder may be in proximity of an infected individual

The likelihood for any exposure to body fluids or contaminated waste as part of the operations

The PPE is recommended in terms of a garment, gloves, eye/face/respiratory protection devices3, and footwear. However, the recommended PPE must form an “ensemble” of clothing and equipment that addresses the need for liquid penetration resistant interfaces (joints between different items of clothing and equipment, such as between gloves and garment sleeves) and the manner in which the ensemble is donned and doffed (particularly when contaminated).

2 Descriptions and specifications for Low Risk and High Risk PPE are found in Appendices 1 and 2 of this document. 3 Respiratory protection equipment must be NIOSH-approved, and used in compliance with all elements of the

OSHA Respiratory Protection Standard, 29 CFR 1910.134, including fit testing, medical evaluation, and training of the first responder.

Symptoms Presented

Ebola Exposure Level Asymptomatic Fever Body Fluids

Known of Suspected Exposure Low Risk* Low Risk High Risk

Possible Exposure SOP Low Risk Low Risk

No Known Exposure SOP SOP SOP *PPE requirements will be determined by the situation. SOP may be also be appropriate if the risk is acceptable.

Figure II-1: PPE Level Selection Table

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V1-5, 10/24/14 5

B. Decontamination In addition to the expected deployment and use of PPE, prospective decontamination procedures and agents must be considered when selecting PPE items, as certain processes may degrade the ensemble during the doffing process and result in exposure.

The CDC has issued “Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus” available at:

http://www.cdc.gov/vhf/ebola/hcp/environmental-infection-control-in-hospitals.html This guidance identifies use of specific disinfectants for use on non-porous surfaces. The CDC 20 October 2014 guidelines further indicate using alcohol-based hand wipes (ABHW) or a disposable wipe impregnated with a U.S. Environmental Protection Agency-registered hospital disinfectant with a label claim of potency at least equivalent to that for a non-enveloped virus (e.g., norovirus, rotavirus, adenovirus, poliovirus). However, these products have not been evaluated for the effects on all PPE items.

Care must be taken in decontaminating PPE. Many recommended disinfectants are designed for use on surfaces rather than PPE. Improper decontamination processes or solutions can damage single-use PPE during the doffing process and cause exposure. Further, the impact of decontamination on multiple-use PPE items (e.g., respirator face pieces or the seams of multi-use garments) is not fully known. Multi-use PPE should be carefully inspected after decontamination and any deterioration monitored.

One common (and improper) approach to decontamination is the notion that increasing the strength of a bleach solution will improve effectiveness. This should NEVER be attempted when decontaminating PPE.

WARNING

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V1-5, 10/24/14 6

III. PPE Recommendations

Specific recommendations are provided for each category of personal protective equipment: garments, gloves, eye/face/respiratory protection devices, and footwear).

Appendix 1 provides a description of the recommended PPE items in terms of their physical features and general performance characteristics. Several alternative configurations are suggested, along with approaches for their integration as an overall ensemble.

Appendix 2 references specific certifications, standards, test methods, and performance levels for recommended PPE. These should be reviewed before procuring any equipment. It also provides links to sites which provide assistance in locating certified products where applicable.

Both tables must be used for the specification of the respective PPE items.

A. PPE Use – Donning The selected PPE must be donned in the correct order in order to provide an effective protection against contact with individuals with Ebola Virus Disease or contamination. The specific donning order depends on the PPE items comprising the ensemble, as the donning process is affected by how interfaces are formed. All PPE should be donned in accordance with an established SOP, under supervision, and with assistance as needed.

B. PPE Use – Doffing Extreme care must be exercised when doffing PPE following use where contamination has occurred or is suspected. A specific sequence for doffing the PPE must be followed, in an order that prevents any contamination transfer from the PPE to the wearer or others. The following considerations should be included in operating procedures for doffing ensembles with known or suspected contamination:

The wearer must assume than any surface could be contaminated.

All doffing must be performed under supervision and with assistance as needed.

The last items removed should be the face/eye protection or respirator, and inner gloves.

While taping may be recommended for some interfaces, it is important to use tape that does not degrade protection. For example, when tape is removed during doffing (particularly a tape with strong adhesive such as duct tape) it can cause a tear in the garment. N95 respirators should never be taped to the hood of a protective coverall or other PPE – this can disrupt the fit of the respirator, which affects its protective performance.

WARNING

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V1-5, 10/24/14 7

Any time the wearer or an individual assisting the wearer in the doffing process touches a potentially contaminated surface or PPE item, the wearer or assisting individual must rinse their gloved hands with an appropriate decontamination solution that does not cause the gloves to degrade.

For some types of ensembles, it is possible to cut off the garment to permit easier doffing without contacting contaminated surfaces. If cutting of the garment is performed, then the procedures used for the cutting process should be accounted for in the garment’s design (e.g., the placement of seams and closures).

C. Additional Considerations in PPE Selection and Use Each organization should ensure that it develops specific SOPs covering all elements of use including donning, doffing, and disposing PPE following use. If PPE is contaminated, it must be isolated, contained, and disposed in accordance with federal, state, and local regulations as applicable to the specific jurisdiction. Finally, all organizations that engage in response operations where there is the potential for using High Risk and Low Risk PPE for Ebola Virus exposure must repeatedly train their members in these procedures.

D. Basis of IAB Recommendations The PPE recommendations herein are based wherever possible on recognized consensus standards that have been applied to PPE, including biological protective clothing and equipment. In some cases, specific recommendations are provided that reference standards for which no certified items are currently available; however, alternative or minimum requirements are also supplied for each type of item. Referenced standards and attributes should be part of any purchase specifications for selecting PPE.

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V1-5, 10/24/14 8

Appendix 1 - PPE Descriptions

PPE Item High Risk Low Risk

Garments Full-body garment constructed of durable viral penetration resistant material and seams with sealable cover flap over closure:

Coverall with integrated hood when worn with full facepiece respirator; or

Coverall without hood when worn with hood-based or helmet-based powered air purifying respirator (PAPR) where hood provides sufficient overlap with garment, or where separate hood covers all portions of wearer’s head, face, and neck while providing sufficient overlap with garment and where hood material meets garment material viral-penetration resistance requirements

Preferred features include splash flaps on sleeves for covering the end of outer gloves and on legs for covering the top of footwear combined with a sock-like bootie extension of the coverall legs

Viral penetration resistant materials that are also “breathable” are preferred over non-breathable materials

Acceptable alternative garments include chemical splash suits and ensembles for chemical, biological, radiological, and nuclear (CBRN) protection

Full body garment constructed of disposable or more durable viral penetration resistant material and seams with sealable cover flap over closure:

Coverall with integrated hood; or

Coverall with separate hood also constructed of viral penetration resistant material and seams

Viral penetration resistant materials that are also “breathable” are preferred over non-breathable materials

Gloves Inner – Single use nitrile rubber inner examination glove (worn underneath coverall sleeve)

Outer – Extended cuff 11 mil or thicker unsupported nitrile, neoprene, or other rubber glove without interior fabric or flocking (worn over coverall sleeve and taped in place if not integrated with suit sleeve)

Inner – Single use nitrile rubber inner examination glove (worn underneath coverall sleeve)

Outer – Extended cuff single use nitrile rubber examination glove (worn over coverall sleeve and taped in place if not integrated with suit sleeve)

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V1-5, 10/24/14 9

PPE Item High Risk Low Risk

Eye/Face/ Respiratory Protection

Full facepiece (elastomeric) air-purifying respirator (APR) with P100 filters: or

Powered air purifying respirator (PAPR) with P100 filters with full face shield, helmet, or hood

Acceptable alternative respirators include open-circuit self-contained breathing apparatus (SCBA) and any CBRN respirator

Tape may be used to seal around the respirator if no gasket or other interface is provided by coverall, suit or ensemble in order to integrate liquid-penetration resistant respirator with garment hood

Fluid-resistant N95 or greater filtering facepiece worn in conjunction with splash-rated, non-vented or indirect-vented goggles and splash-rated full face shield

Tape may be used to seal hood around goggles or face shield if no gasket or other interface is provided by coverall, suit or ensemble to permit liquid-penetration resistant integration of these items with garment hood; the respirator should not be taped to the hood since this practice could affect the seal of the respirator against the wearer’s face and degrade the respiratory protection

Footwear and other accessories

Rubber boots that extend to at least lower calf; or

Footwear that incorporates viral-penetration barrier layer; or

Standard footwear that is covered by a footwear cover that extends beyond height of footwear constructed of viral penetration resistant footwear and that includes a durable wear surface

If garment does not have sock-like bootie extension, then end of coverall legs opening must be taped over boots or over footwear covers worn on top of standard footwear; taping must be performed in a manner that permits full movement of wearer without causing strain on garment material

Footwear that incorporates viral-penetration barrier layer; or

Standard footwear that is covered by a footwear cover that extends beyond height of footwear constructed of viral penetration resistant footwear and that includes a durable wear surface

If garment does not have sock-like bootie extension, then end of coverall leg openings must be taped over boots or over footwear covers worn on top of standard footwear; taping must be performed in a manner that permits full movement of wearer without causing strain on garment material

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Appendix 2 - Detailed Specifications / Standards for Recommended PPE with Associated Standardized Equipment List4 (SEL) links

PPE Item High Risk Low Risk

Garments Garment/hood material and seams meet “pass” requirements of American Society for Testing and Materials (ASTM) F1671 and materials show high levels of tensile strength (≥250 N), tear resistance (≥75 N), and seam strength (≥125 N) when measured to test methods specified in NFPA 1999-2013 [See SEL Item 01EM-02-GARI]

“Breathability” demonstrated when garment material meets above requirements and meets one of the following criteria

Total heat loss (THL) values ≥ 450 W/m2 (per ASTM F1868, Procedure. C); or

Evaporative resistance (Ret) ≤ 10 kPam2/W (per ASTM F1868, Procedure B or ISO 11092); or

Moisture vapor transport rates ≥ 650 g/m2-24 hr (ASTM E96 B) or ≥ 6,000 g/m2-24 hr (ASTM E96 BW)

When and if available, garments certified to multiple-use garment requirements of NFPA 1999-2013 should be specified [See SEL Item 01EM-02-GARM]*

Splash protective garments [See SEL Item 01SP-02-GRMT] or ensembles certified to NFPA 1992-2012 [See SEL Item 01SP-01-ENSN]*

CBRN protective ensembles certified to Class 2 [See SEL Item 01CB-02-ENSM], Class 3 [See SEL Item 01CB-03-ENSM], or Class 4 requirements of NFPA 1994-2012 [See SEL Item 01CB-04-ENSM]*

Garment/hood material and seams meet “pass” requirements of ASTM F1671 and materials show high levels of tensile strength (≥50 N), tear resistance (≥17 N), and seam strength (≥50 N) when measured to test methods specified in NFPA 1999-2013 [See SEL Item 01EM-02-GARI]

“Breathability” demonstrated when garment material meets above requirements and meets one of the following criteria

Total heat loss (THL) values ≥ 450 W/m2 (per ASTM F1868, Procedure. C); or

Evaporative resistance (Ret) ≤ 10 kPam2/W (per ASTM F1868, Procedure B or ISO 11092); or

Moisture vapor transport rates ≥ 650 g/m2-24 hr (ASTM E96 B) or ≥ 6,000 g/m2-24 hr (ASTM E96 BW)

4 The Standardized Equipment List (SEL) is a list of generic equipment items recommended by the IAB to local, tribal, state, and federal government

organizations in preparing for and responding to all-hazards mass casualty events, with an emphasis on CBRNE. An interactive version of the SEL is available at https://iab.gov/SELint.aspx

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PPE Item High Risk Low Risk

Gloves Inner gloves certified to single-use examination glove requirements of NFPA 1999-2013 or meeting ASTM D6319 [See SEL Item 01EM-03-GLME]*

Outer glove [See SEL Item 01ZA-02-GLVD] requirements meet minimum requirements of ANSI/ISEA 105 for Detection of Holes, Level 1 cut resistance, Level 1 puncture resistance, Level 1 abrasion resistance, and Level 3 dexterity

Inner and outer gloves certified to single use examination glove requirements of NFPA 1999-2013 or meeting ASTM D6319 [See SEL Item 01EM-03-GLME]*

Eye/Face/ Respiratory Protection

Respirators certified by NIOSH for respective category – see specific respiratory types at http://www2a.cdc.gov/drds/cel/cel_form_code.asp

[See SEL Items 01AR-02-APR, 01AR-03-PAPA, 01AR-03-PAPM, 01AR-06-DISP, or 01AR-06-REUS]

SCBA that meets NFPA 1981-2013 [See SEL Item 01AR-01-SCBA]*

Note: When a hooded PAPR is used, the hood material must meet the garment requirements above.

Respirators certified by NIOSH for respective category – see “Surgical N95 Respirators” at http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html

Goggles and faceshield that meet ANSI/ISEA Z87.1-2010, including rating for splash [See SEL Item 01ZA-03-EYEP]

Footwear and other accessories

Footwear certified to multiple use emergency medical footwear or emergency medical facility footwear requirement of NFPA 1999-2013 [See SEL Item 01EM-04-FTWR]*; or

Footwear certified to NFPA 1992-2012 [See SEL Item 01EM-04-FTWI]*; or

Footwear certified to Class 2, Class 3, or Class 4 requirements of NFPA 1994-2012 [See SEL Item 01EM-04-FTWI]*

Footwear covers materials and seams must meet “pass” requirements of ASTM F1671 [See SEL Item 01ZA-02-FTWC]

Footwear certified to multiple use emergency medical footwear or emergency medical facility footwear requirement of NFPA 1999-2013 [See SEL Item 01EM-04-FTWR]*; or

Footwear certified to NFPA 1992-2012 [See SEL Item 01EM-04-FTWI]*; or

Footwear certified to Class 2, Class 3, or Class 4 requirements of NFPA 1994-2012 [See SEL Item 01EM-04-FTWI]*

Footwear covers materials and seams must meet “pass” requirements of ASTM F1671 [See SEL Item 01ZA-02-FTWC]

* Products meeting these requirements are listed at www.seinet.org under “Certified Products” link or at www.ul.com under On Line Certifications Directory link (use category code QGWS for NFPA 1999, QGTT for NFPA 1992, and QGTE for NFPA 1994)

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14

Property Test Method Measurement

Performance Criteria in Standard (applicable paragraph)

NFPA 1999-2013

Single Use

Garments

NFPA 1999-2013

Multiple Use

Garments

NFPA 1994-2012

Class 4

(single use)

NFPA 1999-2013

BRN Ensemble

Option

NFPA 1999-2013

Single Use

Footwear Covers

NFPA 1999-2013

Multiple Use

Footwear

Impact resistance

(toe)

ASTM F 2413 Classification Meet classification

for impact

resistance

Meet classification

for impact

resistance

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Compression

resistance (toe)

ASTM F 2413 Classification Meet classification

for compression

resistance

Meet classification

for compression

resistance

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Puncture resistance

(sole)

ASTM F 2413 Classification Meet classification

for puncture

resistance except

flex cracking

resistance

Meet classification

for puncture

resistance except

flex cracking

resistance

Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Abrasion resistance

(sole)

ASTM D 1630

(NFPA 1994)

ISO 4649

(NFPA 1999)

Abrasion

resistance rating

≤ 200 mm3

(7.4.2.3)

65 (7.3.4.5) Same as NFPA

1999-2013

multiple use

footwear (7.6.5)

Abrasion resistance

(footwear cover)

ASTM D 3884

H-18 wheels

1000 gram load

Cycles to wear

through

≥ 3000 (7.4.1.6) ≥ 3,000 cycles

(7.3.4.8)

Slip resistance

(sole)

ISO 13287

(modified)

Coefficient of

friction (NFPA

1992 and 1994)

0.40 (7.4.1.8) 0.40 (7.4.2.4) 0.40 (7.3.4.6) Same as NFPA

1999-2013

multiple use

footwear (7.6.5)