Respiratory protection

during a pandemic –
6th IIHA (Indonesia Industrial Hygiene Association ) 2021

Keith Roddan – Regulatory and Standards Development Manager

23rd Oct 2021

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▪ These slides were shared during the IHA webinar in Indonesia on 23rd
October 2021.
▪ The content was valid as of the date of presentation.
▪ The content of these slides is for review internally by those participating
in the meeting. 3M respectfully requests that you not share this
information with persons outside of the participating companies.
▪ The content of these slides was accompanied by significant and often
clarifying verbal discussion. If you have questions or desire further
explanation, please contact 3M Indonesia.
▪ Thank you

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Agenda

Respirator selection
- Selection criteria
- Major respirator standards (NIOSH, EN, GB, …)
- NIOSH vs BFE, vs PFE, vs VFE
- Recommended respirators in COVID-19 pandemic
(health care workers)

Frauds, fakes and counterfeits.

- How to identify an N95 or P2

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 Important resource center

https://www.3m.com/3M/en_US/worker-health-safety-us/covid19/

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Respirator selection
Selection advice

Mask use in health care settings

• WHO continues to recommend that health workers
(1) providing care to suspected or confirmed COVID-19
patients wear the following types of mask/respirator in
addition to other personal protective equipment that
are part of standard, droplet and contact precautions:
- medical mask in the absence of aerosol
generating procedures (AGPs)
- respirator, N95 or FFP2 or FFP3 standards, or
equivalent in care settings for COVID-19
patients where AGPs are performed; these
may be used by health workers when
providing care to COVID-19 patients in other
settings if they are widely available and if costs
is not an issue.
Recommended infection prevention and control (IPC)
practices when caring for a patient with suspected or
confirmed SARS-CoV-2 infection Personal Protective
Equipment
Healthcare professionals who enter the room of a patient
with suspected or confirmed SARS-CoV-2 infection should
adhere to
Standard Precautions and use a NIOSH-approved N95 or
equivalent or higher-level respirator, gown, gloves,
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Surgical Mask vs Respirator

Primary function to protect the

wearer from the environment

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National respirator approvals/standards

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A comparison of facemask and respirator filtration tests.
Journal of Occupational and Environmental Hygiene, 14:2, 92-103, DOI: 10.1080/15459624.2016.1225157

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Comparison of filter efficiency

How does an N95 respirator filter

compare with a surgical mask rated at
98% BFE?

42 CFR 84 N95 ASTM F2101 BFE ASTM F2100 PFE No standard VFE
Particle size 0.3 microns 3 microns 0.1 micron 3 microns
Flow rate 85lpm 28lpm 28lpm 28lpm

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NIOSH N95 filter test vs BFE, PFE and VFE

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Presented at AIHCE 2011

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Surgical Mask vs Respirator

Primary function to protect the

wearer from the environment

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Standard N95 vs Surgical N95
Standard N95 vs Surgical N95

Standard N95 Surgical N95

Testing Respiratory protection 42 CFR 84 42 CFR 84
Flame retardancy 16 CFR 1610
Fluid Resistance ASTM F1862-2000a
BFE ASTM F2101-01
QMS Usually ISO9000 Usually ISO13485
Approvals NIOSH NIOSH & FDA cleared

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Fakes, Fraud and Counterfeits
NIOSH Marking requirements

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 https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html

21 October
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10/21/2021
European marking requirements – EN149

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China requirements – GB2626-2019
Model number
7. Marking on the device
Marking on the device shall include:
a) Name, trademark or other means of
identification of the manufacturer or supplier;
b) Model or size (if applicable);
c) The number and year of publication of this
standard,
d) filter classification on each filter element. Filter
classification shall be marked in a way of
combining both number of this standard and
filter type and class, for example, GB 2626-
2019 KN95,or GB 2626-2019 KP100.

Manufacturer's Filter classification (KN95)

name
Standard number and year of publication
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Fraud Cases Globally
https://www.3m.com/3M/en_US/worker-health-safety-us/covid19/covid-fraud/
Counterfeit
Counterfeit certificates

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COVID-19 Fraud Webform

https://engage.3m.com/covid-19_anti_fraud_id
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 Web addresses
• EU Approved inspection bodies
https://ec.europa.eu/growth/tools-
databases/nando/index.cfm?fuseaction=notifiedbody.notifiedbodies&char=E
• NIOSH Approved N95 list
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html NIOSH
• NIOSH TESTED LIST EUA
• https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
• 3M Covid Fraud website
https://www.3m.com/3M/en_US/worker-health-safety-us/covid19/ 3M Fraud reporting website
• Report your concerns
CovidFraudID@mmm.com
• 3M Respirator certificates
Respiratory Certificate Selector | Worker Health & Safety | 3M United Kingdom
21 October
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