Difference between revisions of "Technical"
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| − | = | + | =Testing Standards and Requirements= |
| + | ==ISO Digital Headform Sizes== | ||
| + | The National Personal Protective Technology Labratory (NPPTL) has [https://www.cdc.gov/niosh/npptl/topics/respirators/headforms/default.html 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''' [https://global.ihs.com/doc_detail.cfm?&isf=SCC&item_s_key=00554192&item_key_date=840830&input_doc_number=ISO%2FTS%2016976%2D2%3A2015%28EN%29&input_doc_title=#product-details-list 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 [https://www.iso.org/obp/ui#iso:std:iso:ts:16976:-8:ed-1:v1:en 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 [https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0005-05a-06-508.pdf Determination of Qualitative Isoamyl Acetate (IAA) Facepiece Fit Test] | ||
| + | |||
| + | ==Contact with Skin== | ||
| + | The standard is available for free as part of the COVID response [https://www.iso.org/obp/ui#iso:std:iso:10993:-1:ed-5:v2:en 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== | ||
| + | The [https://buyandsell.gc.ca/specifications-for-COVID-19-products#200 buyandsell.gc.ca] website has the technical requirements for the N95 masks | ||
| + | I created a screen capture of the table at this [https://looseletters-my.sharepoint.com/:i:/g/personal/michael_looseletters_onmicrosoft_com/EUnCi_zN-kFCjx42zyfwOUQBByVVpUyUs4Zt8ybevoSr8A?e=9a5uG1 link] | ||
| + | |||
| + | {| class="wikitable" | ||
| + | |- | ||
| + | ! N95 Spec !! Typical | ||
| + | |- | ||
| + | | Filter Performance || >=95% | ||
| + | |- | ||
| + | | Test Agent || NaCl | ||
| + | |- | ||
| + | | Flow Rate || 85 l/min | ||
| + | |- | ||
| + | | Inward leakage || <=8% | ||
| + | |- | ||
| + | | Inhalation Resistance || <=343 Pa | ||
| + | |- | ||
| + | | Flow Rate|| 85 l/min | ||
| + | |- | ||
| + | | Exhalation Resistance || <=245 Pa | ||
| + | |} | ||
| + | |||
| + | ===Face Fit Test Procedures=== | ||
| + | The CDC has [https://www.cdc.gov/niosh/npptl/stps/facefit.html Standard Respirator Testing Procedures] has test procedures for: | ||
| + | *[http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0005-05a-06-508.pdf TEB-APR-STP-0005, 0005a, and 0006Cdc-pdf] Determination of Qualitative Isoamyl Acetate (IAA) Facepiece Fit Test | ||
| + | *[http://www.cdc.gov/niosh/npptl/stps/pdfs/RCT-APR-0067-508.pdf RCT-APR-STP-0067Cdc-pdf] Particulate Respirator Qualitative Fit Test Utilizing Saccharin or Bitrex Solutions | ||
| + | |||
| + | ===ISC Technology Readiness Level Scale=== | ||
| + | ISC is [https://www.ic.gc.ca/eic/site/101.nsf/eng/home Innovative Solutions Canada] | ||
| + | They have a chart that defines the stages of development. | ||
| + | [https://www.ic.gc.ca/eic/site/101.nsf/eng/00077.html 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 | ||
| + | |||
| + | ==Innovative Solutions Canada== | ||
| + | Accelerate your journey to market | ||
| + | |||
| + | Innovative Solutions Canada helps Canadian innovators by funding R&D and testing prototypes in real-life settings. | ||
| + | We have two streams with a combined funding of over $140 million dedicated to Canadian innovators who want to start, grow, and get to market. | ||
| + | |||
| + | [https://www.ic.gc.ca/eic/site/101.nsf/eng/home Innovative Solutions Canada] is a website that lists Open funding opportunities with closing dates for things like: | ||
| + | *[https://www.ic.gc.ca/eic/site/101.nsf/eng/00101.html COVID-19 Challenge: Made in Canada filtration material for the manufacture of N95 respirators and surgical masks] | ||
| + | *[https://www.ic.gc.ca/eic/site/101.nsf/eng/00101.html Call for prototypes to help combat COVID-19] Closes April 21, 2020 | ||
| + | |||
| + | ==Test in Cough Chamber== | ||
| + | Found this article on web [https://www.cbc.ca/news/canada/london/social-distancing-1.5531590 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. | ||
Revision as of 12:03, 18 April 2020
Contents
Testing Standards and Requirements
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
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
The buyandsell.gc.ca website has the technical requirements for the N95 masks I created a screen capture of the table at this link
| N95 Spec | Typical |
|---|---|
| Filter Performance | >=95% |
| Test Agent | NaCl |
| Flow Rate | 85 l/min |
| Inward leakage | <=8% |
| Inhalation Resistance | <=343 Pa |
| Flow Rate | 85 l/min |
| Exhalation Resistance | <=245 Pa |
Face Fit Test Procedures
The CDC has Standard Respirator Testing Procedures has test procedures for:
- TEB-APR-STP-0005, 0005a, and 0006Cdc-pdf Determination of Qualitative Isoamyl Acetate (IAA) Facepiece Fit Test
- RCT-APR-STP-0067Cdc-pdf Particulate Respirator Qualitative Fit Test Utilizing Saccharin or Bitrex Solutions
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
Innovative Solutions Canada
Accelerate your journey to market
Innovative Solutions Canada helps Canadian innovators by funding R&D and testing prototypes in real-life settings. We have two streams with a combined funding of over $140 million dedicated to Canadian innovators who want to start, grow, and get to market.
Innovative Solutions Canada is a website that lists Open funding opportunities with closing dates for things like:
- COVID-19 Challenge: Made in Canada filtration material for the manufacture of N95 respirators and surgical masks
- Call for prototypes to help combat COVID-19 Closes April 21, 2020
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.
