2. ISO Proposed Total Inward Leakage Requirements and their Implications European Section General Meeting March 10, 2011 Bill Newcomb NIOSH/NPPTL Convener of ISO TC94/SC15/WG1, WG1/PG6 and WG2/PG3 TC 094 / SC 15 Respiratory Protective Devices

3. Total Inward Leakage as defined in ISO 16972:2010 Terms, definitions, graphical symbols and units of measurement TC 094 / SC 15 Respiratory Protective Devices Leakage of the ambient atmosphere into the respiratory interface from all sources including filter(s), where present, or device, when measured in the laboratory in the specific test atmosphere

4. Inward Leakage as defined in ISO 16972:2010 Terms, definitions, graphical symbols and units of measurement TC 094 / SC 15 Respiratory Protective Devices Leakage of the ambient atmosphere into the respiratory interface from all sources excluding filter(s), where present, when measured in the laboratory in the specific test atmosphere

5. Therefore, for non-filtering RPD TC 094 / SC 15 Respiratory Protective Devices Total Inward Leakage = Inward Leakage and for filtering RPD Total Inward Leakage = Inward Leakage plus filter penetration

6. Total Inward Leakage Measurement TC 094 / SC 15 Respiratory Protective Devices Three challenge agents listed in draft ISO 16900-1 Test Method - Determination of inward leakage Sulfur hexafluoride Sodium chloride Corn oil The equivalency of the three agents has yet to be demonstrated Gas Solid aerosol Liquid aerosol

7. Total Inward Leakage Measurement TC 094 / SC 15 Respiratory Protective Devices Sulfur hexafluoride must be used if the sealing surface is made from a porous material All TIL measurements are taken at the same workrate regardless of RPD workrate class

8. Total Inward Leakage Measurement TC 094 / SC 15 Respiratory Protective Devices Nine exercises listed in draft ISO 16900-1 Test Method - Determination of inward leak age 1.Acclimatization 2.Standing still 3.Reaching up and down 4.Squatting 5.On hands and knees with head movements 6.Walking 7.Walking with head movements 8.Walking and speaking 9.Standing still

9. Test Subjects TC 094 / SC 15 Respiratory Protective Devices Test subjects chosen by their facial characteristics according to ISO TS16976-2:2010 Anthropometrics, using the Principle Component Analysis (PCA) Panel explained therein

10. Test Subjects - PCA Panel TC 094 / SC 15 Respiratory Protective Devices

11. Test Subjects TC 094 / SC 15 Respiratory Protective Devices The number of test subjects has yet to be determined As a result the pass/fail criteria has not been established

12. Test Subjects TC 094 / SC 15 Respiratory Protective Devices How to determine which test subject to use for a specific size device has yet to be determined For example, three sizes of a facepiece model, small, medium and large are to be evaluated

13. Test Subjects - PCA Panel TC 094 / SC 15 Respiratory Protective Devices Small Medium Large

14. Measurement Method TC 094 / SC 15 Respiratory Protective Devices There are two method of the treatment of measurement currently under discussion for determination of Pass or Fail 1.The inward leakage of each exercise as a single data point 2.The mean leakage of all the exercises as a single data point

15. TIL Requirements TC 094 / SC 15 Respiratory Protective Devices There are six levels of TIL in the proposed documents 1.≤ 20.0% 2.≤ 5.0% 3.≤ 1.0% 4.≤ 0.1% 5.≤ 0.01% 6.≤ 0.001%

16. Protection Level as defined in ISO 16972:2010 Terms, definitions, graphical symbols and units of measurement TC 094 / SC 15 Respiratory Protective Devices Degree of respiratory protection allocated to an RPD for the purposes of selection and use that is expected to be provided to wearers when used within an effective RPD program as described in ISO 16975

17. Proposed Protection Levels TC 094 / SC 15 Respiratory Protective Devices Where SF is a Safety Factor which increases with the decrease in TIL

18. Protection Level and Classes TC 094 / SC 15 Respiratory Protective Devices TIL SF PLClass ≤ 20.0%1.25 4PL1 ≤ 5.0% 2 10PL2 ≤ 1.0% 3.3 30PL3 ≤ 0.1% 4 250PL4 ≤ 0.01% 5 2,000PL5 ≤ 0.001% 10 10,000PL6

19. Implications of the TIL Testing TC 094 / SC 15 Respiratory Protective Devices Users will select respirators based upon a hazard assessment, an adequacy assessment, including protection level, and a suitability assessment The hazard assessment may be done by hazard ratio calculation or controlled banding method

20. Implications of the TIL Testing TC 094 / SC 15 Respiratory Protective Devices Each respirator will be tested and a PL class assigned to it, independent of respiratory interface type or mode of operation Neither Filtering RPD nor Supplied Breathable Gas RPD are restricted to certain PL Neither a traditional half-mask nor a full facepiece RPD are restricted to a certain PL

21. Implications of the TIL Testing TC 094 / SC 15 Respiratory Protective Devices Since only complete respirators will have a PL class, two respirators using the same facepiece with a different filter may have a different TIL and therefore a different PL Will require education of the users

22. Implications of the TIL Testing TC 094 / SC 15 Respiratory Protective Devices PL are only applicable when used in a complete respiratory protection program including individual fit testing of wearers, where applicable The fit test requirements have not been established yet

23. Individual Fit Testing TC 094 / SC 15 Respiratory Protective Devices For example: for a class PL1, a PL of 4, what fit factor must be obtained to determine the pass/fail? for a class PL3, a PL of 30, what fit factor must be obtained ? Can it be either QLFT or QNFT?

24. Still a lot of Questions to be answered! TC 094 / SC 15 Respiratory Protective Devices ?

25. Thank You! TC 094 / SC 15 Respiratory Protective Devices Disclaimer: The findings and conclusions in this presentation have not been formally disseminated by the National Institute for Occupational Safety and Health and should not be construed to represent any agency determination or policy. Further, they are the opinions of the presenter and do not represent the views of ISO, SC15 or the ISRP.