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Testing Standards and Requirements

ISC Technology Readiness Level Scale

ISC is Innovative Solutions Canada They have a chart that defines the stages of development. Technology Readiness Levels (TRL) describe the different stages of pre-commercial development. Find TRL 1 to 9 definitions, descriptions and examples.

Currently 2020-4-17 at between levels 5.TRL and 6.TRL . Funding is looking for projects in the 7.TRL to 9.TRL

Standard Sizes

ISO Digital Headform Sizes

The National Personal Protective Technology Labratory (NPPTL) has NIOSH Anthropometric Data and ISO Digital Headforms available in .stl .ply and .igs format. The five nominal sizes are:

  • Small
  • Medium
  • Large
  • Long/Narrow
  • Short/Wide

The headforms will be available from NIOSH for those who complete the data use agreements. To obtain the digital headforms or more information, please contact Dr. Ziqing Zhuang at ZZhuang1@cdc.gov .

This ISO standard is available for purchase ISO/TS 16976-2:2015(en) Respiratory protective devices — Human factors — Part 2: Anthropometrics

This ISO standard is available online and for free as part of the Covid19 response ISO/TS 16976-8:2013(en) Respiratory protective devices — Human factors — Part 8: Ergonomic factors

NIOSH Testing Procedure Head Classifaction Size

The Facepiece Fit Test procedure requires the participants to be classified by size and provides a chart and a procedure to classify the 10 different sizes. See pages 10 and 11 of the Determination of Qualitative Isoamyl Acetate (IAA) Facepiece Fit Test

Current Parametric Dimensions of Sizes

Using the Table 5 from ISO/TS 16976-2 for the Mean Sizes of the "5 defined headforms"

I made the following assumptions:

  1. Mask Width = 70% of Face Width
  2. Mask Height = Face Height - 40% of Nose Height - 70% of Mouth to Chin Height
  3. Mask Depth = Adjusted to Match ISO Headforms
# Size Face Height Face Width Mask Height Mask Width Half Width Mask Depth Connector Size Connector Height
21 Small 4.3" 5.0" 2.51" 3.56" 1.78" 1.55" 1.00" 0.70"
31 Short Wide 4.6 5.0" 2.60" 3.89" 1.94" 1.55"
51 Medium 4.7" 5.5" 2.71" 3.82" 1.91" 1.40" 1.20" 0.75"
71 Tall Narrow 5.0" 5.5" 2.86" 3.86" 1.93" 1.54"
81 Large 5.0" 5.7" 3.15" 4.20" 2.10" 1.57" 1.40" 0.80"

Contact with Skin

The standard is available for free as part of the COVID response ISO 10993-1:2018 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process

This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:

— the patient's body during intended use;

— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).

Filter Requirements

N95 Specifications

The buyandsell.gc.ca website has the technical requirements for the N95 masks I created a screen capture of the table at this link

Lines with * are based on current design of 10 sq. inches.

N95 Spec Requirement Alternate Imperial
Filter Performance >=95%
Test Agent NaCl
Flow Rate 85 l/min 1.4 l/sec 85.4 cu.in./sec
Filter Area* 0.00645 sq.m. 64.5 sq.cm. 10.0 sq.in
Air Speed* 13.1 m/min 21.7 cm/sec 8.54 in./sec
Inward leakage <=8%
Inhalation Resistance <=343 Pa 35.0 mmH2O 1.38 inchH2O
Flow Rate 85 l/min 1.4 l/sec 85.4 cu.in./sec
Exhalation Resistance <=245 Pa 25.0 mmH2O 0.98 inchH2O

Suppliers

Freudenburg Filtration Technologies

649 Wilton Grove Rd, London, ON N6N 1N7
(519) 686-9888
https://www.freudenberg-filter.com/en/

Called on 2020-4-21 and left a message for engineering.

Dynamic Filtration Ltd

DYNAMIC FILTRATION, LTD.
55 Bathurst Dr., Waterloo 
Ontario, Canada N2V 1N2
Toll Free: 800.265.4544
Phone: 519.886.0749
Fax: 519.884.4390
http://www.dynamicfiltration.ca/

Sent a request a quote form on 2020-4-21 with a .pdf picture of Mask with cord with the following information.

Hello I have designed a mask filter holder and I am looking for a suitable filter material.  The goal is to create a mask that can both 
trap a cough, or any water droplets coming out of the mouth and also prevent anything foreign from getting in the mouth or nose.  I have 
a website that explains more about the project.
Thank you for you time and any information you can provide.
Your assistance is appreciated.
Michael

Stephanie promptly replied with:

Hi Michael,
Thanks for your email.  Unfortunately this is not something we can be involved in or supply to you.  We don't service any facet of the 
healthcare industry, nor do we have a media that would provide adequate capture for moisture droplets.
I do wish you good luck in your search, this is definitely an admirable undertaking!
Best,
Stephanie Gaber
General Manager

On 2020-4-21 I responded with:

Hello Stephanie
Thank you for your prompt reply.
Do you have any idea who I would contact to find such a material?
---
Michael Van Raay

On 2020-4-21 Stephanie responded with:

Hi Michael,
I would suggest reaching out to Albarrie Canada in Barrie, ON.  You can try speaking with Parker Robinson, he is the Division Sales 
Manager.  His email is parker_robinson@albarrie.com. 
Alternately, you can reach out to Kyle Naylor, President of Industrial Filter Manufacturing in Penetanguishene, ON.  Kyle's email is 
knaylor@liquidfiltration.com.
Fell free to mention my name as having referred you to either of them, we deal with both companies & have good long standing 
relationships.
Best of luck!
Stephanie Gaber
General Manager

Dafco Filtration Group

5390 Ambler Dr
Mississauga, ON
L4W 1G9
Canada
Contact: Kevin Cinel
Phone: 1 888 628-3458
Email: KCINEL@FILTRATIONGROUP.COM

On 2020-4-21 I sent an email to Kevin Cinel - Ontario Sales Manager with the following request. I included the maskwithcord.pdf image.

Hello Kevin
I have designed a mask filter holder and I am looking for a supplier of suitable filter material.  The goal is to create a mask that can 
both trap a cough, or any water droplets coming out of the mouth and also prevent anything foreign from getting in the mouth or nose.  
The goal is to thermoform these holders at a rate of 20,000 per 8 hour shift.  Each filter uses about 1/4 sq.ft. so I will require bout 
5000 sq.ft per day.  I have a website that explains more about the project. www.mvrdesigns.ca/mask
The N95 mask requirements are:
(insert N95 Table)
The current filter area is 10 sq.in.  Do you have any materials that can achieve (or come close) to these specs?
Thank you for you time and any information you can provide.
Your assistance is appreciated.
Michael

TriDim A Mann+Hummel Company

https://www.tridim.com/contact-tri-dim-hardy/
Toronto Office
Regional Manager: Graham MacDonald
120 Middlefield Road, Unit 3A
Scarborough, ON
M1S 4M6
Phone: (416) 396-3396
Fax: (416) 609-0780
Email: g.macdonald@tridim.com

On 2020-4-21 I sent an email to Graham at the Toronto Office with the following request.

Hello Graham
I have designed a mask filter holder and I am looking for a supplier of suitable filter material.  The goal is to create a mask that can 
both trap a cough, or any water droplets coming out of the mouth and also prevent anything foreign from getting in the mouth or nose.  
The goal is to thermoform these holders at a rate of 20,000 per 8 hour shift.  Each filter uses about 1/4 sq.ft. so I will require bout 
5000 sq.ft per day.  I have a website that explains more about the project. www.mvrdesigns.ca/mask
The N95 mask requirements are:
(insert N95 Table)
The current filter area is 10 sq.in.  Do you have any materials that can achieve (or come close) to these specs?
Thank you for you time and any information you can provide.
Your assistance is appreciated.
Michael

Albarrie Canada Limited

Albarrie Canada Limited
85 Morrow Road
Barrie, ON  L4N 3V7
Canada
Toll Free: 1-866-269-8275
Tel: 1-705-737-0551
Fax: 1-705-737-4044
Email: parker_robinson@albarrie.com

Stephanie Gaber General manager at Dynamic Filtration Inc recommended I contact Parker Robinson at Albarrie Canada Limited On 2020-4-21 I sent the following:

Hello Parker
Stephanie Gaber at Dynamic Filtration Ltd recommended I contact you.
I have designed a mask filter holder and I am looking for a supplier of suitable filter material.  The goal is to create a mask that can 
both trap a cough, or any water droplets coming out of the mouth and also prevent anything foreign from getting in the mouth or nose.
To create a mask for the essential workers in the processing and food industries who have no choice but to work in close proximity.  
The goal is to thermoform these holders at a rate of 20,000 per 8 hour shift.  Each filter uses about 1/4 sq.ft. so I will require bout 
5000 sq.ft per day.  I have a website that explains more about the project. www.mvrdesigns.ca/mask
The N95 mask requirements are:
(insert N95 Table)
The current current design has a filter area is 10 sq.in.  Do you have any materials that can achieve (or come close) to these specs?
Thank you for you time and any information you can provide. I am happy to answer any questions.
Your assistance is appreciated.
Michael

Tenaquip=

On May 8 2020 I ordered a pack of 12"x 12" Kimtech Pure* W4 Dry wipes that are 100% polypropylene made by Kimberly Clark from Tenaquip

Berkshire

On 2020-05-07 I requested a sammple of Pro Wipe-OS from Berkshire in USA

Face Fit Test Procedures

The CDC has Standard Respirator Testing Procedures has test procedures for:

Test in Cough Chamber

Found this article on web Scientists built 'cough chamber' to see how far droplets actually travel

What researchers at Western University, in collaboration with virologists from Toronto's Sunnybrook Hospital, found is that when someone coughs without covering their mouth, the germ-laden cloud of fine mist they release will not only travel two metres in three seconds, it will continue to travel beyond and even float in the air within that two-metre area for up to three minutes after being released.

Need to find out if they can test our masks.

Are masks needed?

The CCOHS published the following simple answer worksheet. https://www.ccohs.ca/oshanswers/prevention/respiratory_protection.html?=undefined&wbdisable=true

Government of Canada Non-medical masks and face coverings: About https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks/about-non-medical-masks-face-coverings.html

Optimizing the use of masks and respirators during the COVID-19 outbreak https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/masks-respirators-covid19.html

Non-medical masks and face coverings: Sew and no-sew instructions https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks/sew-no-sew-instructions-non-medical-masks-face-coverings.html