iso respiratory protection update · 2016. 6. 13. · iso classification – protection class/til...

ISO Respiratory Protection Update

May 25, 2016

Craig E. Colton, CIH

3M Personal Safety Division

3 . All Rights Reserved. 13 June 2016 © 3M 3M Confidential.

Agenda

ISO TC94 SC15 Background/History

ISO Standards and Products

• Completion Dates/Goals

Selection and Use Overview

• Fit Testing Requirements

Respiratory Protective Device (RPD) Classification

• Protection Levels

Questions


Summary of Background/History of ISO TC94/SC15

2001 - Technical Committee on Personal Safety – Protective clothing and

equipment (TC94) voted to form a sub-committee (SC15) to write standards for

“Respiratory protective devices”

March 2002 - First meeting – have met every year since

EN Respiratory Protection Standards were on hold until (2013)

― CEN TC79 was reactivated in 2013 after being dormant since 2002

Currently 26 countries participate as Primary (Voting) members


ISO TC94 SC15 Participating Countries 26 Voting and 5 Observing Australia

Belgium

Brazil

Canada

Chile

China

Denmark

Finland

France

Germany

Hungary

India

Ireland

Italy

Japan

Mexico

Netherlands

Poland

Portugal

South Africa

South Korea

Spain

Sweden

Switzerland

United Kingdom

USA

• Observing Countries

•Czech Republic

•New Zealand

•Romania

•Serbia

•Slovakia


Working Structure – ISO TC 94/SC15 – Changed November 2015

Working Group 1

Terminology, Classification and Marking

Craig Colton

Working Group 2

Filtering Devices

Thomas Krugerke

Working Group 3

Supplied breathable gas devices

Wolfgang Drews

Working Group 4

Test Methods

Graham Bostock

Working Group 5

Physiological

Requirements

Ian Maxwell

Working Group 6

Selection, Use

& Maintenance

Charles Tracy

Working Group 7

CBRN

Simon Smith

TC 94 SC15

"Respiratory Protective

Devices"

Wolfgang Drews


Current Status and Estimated Timeline of Documents

ISO TC94

SC15 Document

Status as of 4-2016

WG4 ISO 16900-1 Inward Leakage ← Published Published 10-14

WG4 ISO 16900-2 Breathing Resistance Revision Under Revision 2015

WG4 ISO 16900-3 Particle filter efficiency ← Published Published 11-12

WG4 ISO 16900-4 Gas filter capacity ← Published Published 9-11

WG4 ISO 16900-5 Tools DIS Approved 10-27 - 2nd DIS or Publication

WG4 ISO 16900-6 Mechanical resistance ← Published Published 10-15

WG4 ISO 16900-7 Practical performance ← Published Published 9-15

WG4 ISO 16900-8 Air flow rate ← Published Published 6-15

WG4 ISO 16900-9 Carbon dioxide ← Published Published 10-15

WG4 ISO 16900-10 Flame and heat ← Published Published 10-15

WG4 ISO 16900-11 Field of vision ← Published Published 10-13

WG4 ISO 16900-12 Work of breathing FDIS approved 3-16

WG4 ISO 16900-13 Closed circuit gases ← Published Published 10-15

WG4 ISO 16900-14 Noise level ← Published Published 11-15

WG1 ISO 16972 Terms and Definitions Revision Out for revision 2015

WG1 ISO TS 16973 Classification Published TS Publication - 2016

WG1 ISO TS 16974 Marking and information Published

WG6 ISO TS 16975-1 Selection and use 3rd DIS received Negative Vote. TS in January 2016

WG6 ISO TS 16975-2 Selection and use short form 3rd TS out for voting due 9/27/2015

WG6 ISO 16975-3 Fit Testing Methods DIS - Approved - 5-19-2015

WG5 ISO TS 16976-1 Metabolic rates ← Published Published

WG5 ISO TS 16976-2 Anthropometrics ← Published Published

WG5 ISO TS 16976-3 Oxygen and carbon dioxide Revision Under Revision 2015

WG5 ISO TS 16976-4 Work of Breathing ← Published Published

WG5 ISO TS 16976-5 Thermal effects ← Published Published

WG5 ISO TS 16976-6 Psycho-Physiological ← Published Published

WG5 ISO TS 16976-7 Hearing and speech ← Published Published

WG5 ISO TS 16976-8 Ergonomics ← Published Published

WG3 ISO17420-1 Breathable gas RPD NWIP Approved 10-15 - CD

WG2 ISO17420-2 Filtering RPD NWIP Approved 10-15 - CD

WG2 ISO17420-3 Connector thread Revision NWIP Due 1-15-16

WG7 ISO17420-4 CBRN NWIP Approved 9-14 DTS

201920182017

← Published

2016


ISO 16975 Respiratory Protective Devices – Selection, Use and Maintenance Part 1: Establishing and implementing a respiratory protective device

programme

• Technical Specification

• Outlines the ISO RPD Respirator Program

Part 2: Condensed guide to establishing and implementing a respiratory protective device programme

• Technical Specification

• Provides a work sheet

Part 3: Fit testing procedures

• Next version is a DIS; Last stage before final


RPD Selection

Selection is driven by ‘protection levels’ derived by TIL results but also refer to existing APF

APF and protection level used in the same manner

Control banding for materials without OELs


Part 3: Fit Testing Procedures

Similar to ANSI Z88.10 – 2010

Fit tester qualifications

Fit test considerations

Fit test records

Fit testing procedures • Qualitative fit testing (QLFT)

• Saccharin • Bitrex® • Isoamyl acetate

• Quantitative fit testing (QNFT) • Generated aerosol

• Condensation particle counting

• Controlled negative pressure

Bitrex® is a registered trademark of Macfarlan

Smith


ISO Terminology

ISO 16972-2010 Respiratory protective devices — Terms, definitions, graphical symbols and units of measurement

End-of shelf-life; storage conditions

New terminology in many cases • Assisted vs unassisted filtering RPD • Supplied breathable gas RPD vs atmosphere supplying

No terms for respirator types • Half mask • Full facepiece • PAPR • SCBA

Classification


ISO Classification – Protection Class/TIL

Total inward leakage test is the basis of ISO

Classification in the two performance standards

ISO Respiratory Protective Devices (RPD) are not

defined by ‘type’

―No design related limits on class

― theoretically a respirator can achieve the

highest or lowest PC class regardless of what

‘type’ it is


“Protection Levels”

ISO defines Protection Level as: the degree of respiratory protection allocated to a respiratory protective

device, for the purposes of selection and use that is expected to be provided to wearers when used within an effective respiratory protection program as described in ISO 16975-1 (Selection, Use and Maintenance standard).

ISO ‘protection levels’ are based on a laboratory test and assigned regardless of ‘Type’ of respirator

US OSHA APF are based on work place studies and assigned by ‘Type’ of respirator


Selection and Use - TIL and Protection Level

TIL%

(max)

Safety

Factor

Protection Level Class

0.001 100000 10.0 10000 PC6

0.01 10000 5.0 2000 PC5

0.1 1000 4.0 250 PC4

1 100 3.3 30 PC3

5 20 2.0 10 PC2

20 5 1.25 4 PC1


Work Rates

Work rate classification

Four classifications W1 – W4

Manufacturer determines what

class to certify to

Work rate class then determines

test flow rates

Selection and use standard

directs user to determine what

work rate class is needed


Respiratory Interface Class


Filters

Filters are classified by performance, work rate class and ‘single shift’ or ‘reusable’ (multi-shift)

These requirements result in a lot of particle filter options for the end user – could be more than 20

• i.e. 9 NIOSH particle filter categories today – 2 filters (N95, P100) are the primary filters used

Wider capacity range of Gas and Vapor Filters - Chemical cartridge capacity may be better matched to exposure levels (e.g., small capacity cartridge for short or low level exposures)


Breathable Gas Supply (Atmosphere-Supplying)

Classification is

based on ‘Gas

Capacity’

― SY for air line

― SXXXX for cylinders

• XXXX = volume in liters


Special Applications


Classification Example


Notes on Classification

Similar looking respirators may have different classifications

Three half masks may all have different classifications

Different looking devices may be classified the same

PAPR, Full Face and Half Mask


Classification Examples

Basic Performance

Characteristic

Full Face Assisted

(PAPR)

Full Face Unassisted

(Neg. Pressure)

Half Mask Assisted

(PAPR)

Protection class PC4 PC4 PC4

Respiratory Inlet cT cT bT

Work rate W1 W1 W1

Particle Filter Efficiency F2 F3 F4

Basic Performance

Characteristic

Half Mask Particulate Half Mask Particulate Half Mask Particulate

Protection class PC2 PC3 PC1

Respiratory Inlet bT bT bT

Work rate W1 W1 W1

Particle Filter Efficiency F2 F3 F3


Find out more/participate

To get more information on the US TAG:

Contact Colleen Miller, USTAG Administrator, at [email protected] or 412-

386-4956.

The US TAG welcome page can be found at

http://www.ustagrespirators.com/

mailto:[email protected]://www.ustagrespirators.com/