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DI = TO for Tobacco Product Identifier SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier DO/DU = Tobacco Design Parameters (DP) LB = Tobacco Product Testing (TT) |
This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Cigarette. There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.
Tobacco Products (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.
SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???
illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
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Option 1 of Steve H's suggestion of combining our previous product identifiers and product descriptors into a single dataset:| Rowcaps |
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| Rows 1-4: | Show the records for a tobacco product given SPTOBID of CIG01a. | | Rows 3-4: | Show the tobacco product is a filtered, combusted type of cigarette. | | Dataset2 |
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| Row | STUDYID | DOMAIN| Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOVAL | TOVALU | 1 | TOB07 | TO | CIG01a | 1 | TBPRDCAT | Tobacco Product Category | Cigarette | 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory | Filtered, Combusted | 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer | Joes Cigs USA | 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name | Treetop Menthol King Size | 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type | HARD PACK |
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| 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity | 20 | CIGARETTE | | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length | 86.0 | mm | | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference | 26.0 | mm | | 9 | TOB07 | TO | CIG01a | 9 | VENTLTN | Ventilation | 10.0 | % | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor | MENTHOL |
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Option 2 of Steve H's suggestion of combining our previous product identifiers and product descriptors into a single dataset: | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU | TOCOLSRT| TOVAL | TOVALU |
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| 1 | TOB07 | TO | CIG01a | | TBPRDCAT | Tobacco Product Category | NEW PRODUCT |
CigaretteCigarette| Cigarettes |
| | 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory |
Filtered, Combusted| NEW PRODUCT | PRODUCT IDENTIFIER | Filtered |
, Combusted |
| | 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer |
| NEW PRODUCT | PRODUCT IDENTIFIER |
Joes Cigs USA | Joes Cigs USA |
| | 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name |
Treetop Methol King Size| NEW PRODUCT | PRODUCT IDENTIFIER | Treetop |
Methol | Menthol King Size |
| | 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type |
| NEW PRODUCT | PRODUCT DESCRIPTOR |
HARD PACK | HARD PACK |
| | 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity |
20CIGARETTE20 | | CIGARETTE | | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length |
86.0 | mm | | NEW PRODUCT | PRODUCT DESCRIPTOR |
86.0 | 86.0 | mm | | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference |
26.0 | | NEW PRODUCT | PRODUCT DESCRIPTOR |
mm26.0 | VENTLTN| VENTLTOT | Total Ventilation |
10.0 | % | | NEW PRODUCT | PRODUCT DESCRIPTOR |
10.0 | 10.0 | % | | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor | NEW PRODUCT |
MENTHOL| PRODUCT DESCRIPTOR | MENTHOL |
11 | TOB07 | TO | CIG01a | 11 | HTSOURCE | Heat Source | xxx | xxx | |
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The Tobacco Product Design Parameters (DP) is (similar to the Device Properties (DO) domain) represents properties of the tobacco product as used. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer (tobacco researcher) wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TTTESTCD/TTTEST.
The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the PD domain The following example shows the target, minimum, and maximum values associated with each of 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.
Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.
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| Rows 1-4: | Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference. |
| Row 5: | Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1 |
| Row 6: | Shows the characterizing flavor is menthol for this package of cigarettes. |
Row 7: | Shows the heat source is xxx. | | Dataset2 |
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DPSEQDPTESTCDDPTESTDPCATDPSCATDPORRESDPORRESU| DPSTRESC | DPSTRESN | DPSTRESU | DPCOLSRT | DPDESIGN PARAMETER SPECIFICATIONTARGETDPLENGTH | Length | DESIGN PARAMETER SPECIFICATION | mm | MINIMUM | CIRCUMF | Circumference | 24.8 | 24.6 | 25 | mm | | 3 | TOB07 |
DPLENGTHLengthDESIGN PARAMETER SPECIFICATIONmmMAXIMUMDPCIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATIONmmTARGETDPCIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION | mm | | TOCUTSIZ | Tobacco Cut Size | | | 24 | |
MINIMUMDPCIRCUMF | Circumference | | TOCUTSIZ | Tobacco Cut Size | | | 29 |
DESIGN PARAMETER SPECIFICATIONMAXIMUM | DPTBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION | mg | TARGETDPTBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION | mg | | TPNPLGTH | Tipping Paper Length | 31 | 30 | 32 | mm |
MINIMUMDPTBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION | mg | | CBPPOR | Cigarette Base Paper Porosity | | | 55 | Cu |
MAXIMUMDPMOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION | % | | CBPPERM | Cigarette Base Paper Permeability | | | 55 | |
TARGETDPMOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION | % | | CPBPOR | Cigarette Paper Band Porosity | 10 | 0.2 | 13 | Cu |
MINIMUMDPMOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION | % | | CPBPERM | Cigarette Paper Band Permeability | 10 | 0.2 | 13 | Cu |
MAXIMUMDPTOCUTSIZ | Tobacco Cut Size | mm or cuts per inch 2 | | | Cigarette Paper Band Diffusivity | 0.05 | 0.001 | 0.100 | cm2/s |
TARGETDPTOCUTSIZ | Tobacco Cut Size | mm or cuts per inch 2 | | CPBWID | Cigarette Paper Band Width | | | 7.3 | |
MINIMUMDPTOCUTSIZ | Tobacco Cut Size | mm or cuts per inch 2 | | CPBSPC | Cigarette Paper Band Space | 20 | | 20.2 | |
MAXIMUMDPFLTRVENT VentilationTARGETDPFLTRVENT | Filter Ventilation | % | | Denier Per Filament | 4 | 3.6 | 4.4 |
MINIMUMDP| PD | CIG01a | | 18 | TDENIER | Total Denier |
FLTRVENTFilter Ventilation%MAXIMUMDPTPNPLGTH | Tipping Paper Length | mm | | FLTRDEN | Filter Density | 0.1234 | 0.105 | 0.1419 | g/cm3 |
TARGETDPTPNPLGTHTipping Paper Length | mm | | Filter Length | 25 | 24.5 | 25.5 | mm |
MINIMUMDPTPNPLGTH | Tipping Paper Length | mm | | FLTPRDRP | Filter Pressure Drop | 60 | 51 | 69 | mm H2O |
MAXIMUMDPCIGBPPOR | Cigarette Base Paper Porosity or Permeability | CORESTA Unit (Cu) | | TORODDEN | Tobacco Rod Density | 0.2678 | 0.2437 | 0.2919 | g/cm3 |
TARGETDPCIGBPPOR Base Porosity or PermeabilityCORESTA Unit (Cu) | MINIMUM | 24 | TOB07 | DP | CIG01a | 24 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability | CORESTA Unit (Cu) | MAXIMUM | 25 | TOB07 | DP | CIG01a | 25 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity | CORESTA Unit (Cu) or cm2/s | TARGET | 26 | TOB07 | DP | CIG01a | 26 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity | CORESTA Unit (Cu) or cm2/s | MINIMUM | 27 | TOB07 | DP | CIG01a | 27 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity | CORESTA Unit (Cu) or cm2/s | MAXIMUM | 28 | TOB07 | DP | CIG01a | 28 | CPBNDWID | Cigarette Paper Band Width | mm | TARGET | 29 | TOB07 | DP | CIG01a | 29 | CPBNDWID | Cigarette Paper Band Width | mm | MINIMUM | 30 | TOB07 | DP | CIG01a | 30 | CPBNDWID | Cigarette Paper Band Width | mm | MAXIMUM | 31 | TOB07 | DP | CIG01a | 31 | CPBNDSPC | Cigarette Paper Band Space | mm | TARGET | 32 | TOB07 | DP | CIG01a | 32 | CPBNDSPC | Cigarette Paper Band Space | mm | MINIMUM | 33 | TOB07 | DP | CIG01a | 33 | CPBNDSPC | Cigarette Paper Band Space | mm | MAXIMUM | 34 | TOB07 | DP | CIG01a | 34 | FLTREFF | Filter Efficiency | % | TARGET | 35 | TOB07 | DP | CIG01a | 35 | FLTREFF | Filter Efficiency | % | MINIMUM | 36 | TOB07 | DP | CIG01a | 36 | FLTREFF | Filter Efficiency | % | MAXIMUM | 37 | TOB07 | DP | CIG01a | 37 | DPF | Denier Per Filament | /filament | TARGET | 38 | TOB07 | DP | CIG01a | 38 | DPF | Denier Per Filament | /filament | MINIMUM | 39 | TOB07 | DP | CIG01a | 39 | DPF | Denier Per Filament | /filament | MAXIMUM | 40 | TOB07 | DP | CIG01a | 40 | DENIER | Denier | g/9000 m | TARGET | 41 | TOB07 | DP | CIG01a | 41 | DENIER | Denier | g/9000 m | MINIMUM | 42 | TOB07 | DP | CIG01a | 42 | DENIER | Denier | g/9000 m | MAXIMUM | 43 | TOB07 | DP | CIG01a | 43 | FLTRDEN | Filter Density | g/cm3 | TARGET | 44 | TOB07 | DP | CIG01a | 44 | FLTRDEN | Filter Density | g/cm3 | MINIMUM | 45 | TOB07 | DP | CIG01a | 45 | FLTRDEN | Filter Density | g/cm3 | MAXIMUM | 46 | TOB07 | DP | CIG01a | 46 | FLTRLGTH | Filter Length | mm | TARGET | 47 | TOB07 | DP | CIG01a | 47 | FLTRLGTH | Filter Length | mm | MINIMUM | 48 | TOB07 | DP | CIG01a | 48 | FLTRLGTH | Filter Length | mm | MAXIMUM | 49 | TOB07 | DP | CIG01a | 49 | FLTPRDRP | Filter Pressure Drop | mm H2O | TARGET | 50 | TOB07 | DP | CIG01a | 50 | FLTPRDRP | Filter Pressure Drop | mm H2O | MINIMUM | 51 | TOB07 | DP | CIG01a | 51 | FLTPRDRP | Filter Pressure Drop | mm H2O | MAXIMUM | 52 | TOB07 | DP | CIG01a | 52 | TORODDEN | Tobacco Rod Density | g/cm3 | TARGET | 53 | TOB07 | DP | CIG01a | 53 | TORODDEN | Tobacco Rod Density | g/cm3 | MINIMUM | 54 | TOB07 | DP | CIG01a | 54 | TORODDEN | Tobacco Rod Density | g/cm3 | MAXIMUM | 55 | TOB07 | DP | CIG01a | 55 | Cigarette Paper Length | CIGPLGTH | mm | TARGET | 56 | TOB07 | DP | CIG01a | 56 | Cigarette Paper Length | CIGPLGTH | mm | MINIMUM | 57 | TOB07 | DP | CIG01a | 57 | Cigarette Paper Length | CIGPLGTH | mm | MAXIMUM | |
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Rows 1-4: | | Row 5: | S |
Row 6: | Row 7: | | Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | TTSEQ | TTREFID | TTGRPID | TTTESTCD | TTTEST | TTCAT | TTORRES | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESU | TTCOLSRT |
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1 | TOB07 | TT | CIG01a | 1 | Tobacco Filler mass | mg | | 2 | TOB07 | TT | CIG01a | 2 | Tobacco moisture or Oven Volatiles | % | % | 3 | TOB07 | TT | CIG01a | 3 | Tobacco cut size | mm or cuts per inch 2 | mm or cuts per inch 2 | 4 | TOB07 | TT | CIG01a | 4 | Tobacco Rod density | g/cm3 | g/cm3 | 5 | TOB07 | TT | CIG01a | 5 | Filter Ventilation | % | % | 6 | TOB07 | TT | CIG01a | 6 | Cigarette base paper Porosity or Permeability | CORESTA Unit (Cu) | CORESTA Unit (Cu) | 7 | TOB07 | TT | CIG01a | 7 | Cigarette Paper band porosity or permeability or band diffusivity | CORESTA Unit (Cu) or cm2/s | CORESTA Unit (Cu) or cm2/s | 8 | TOB07 | TT | CIG01a | 8 | Filter efficiency 1 | % | % | 9 | TOB07 | TT | CIG01a | 9 | Denier per Filament | DPF | DPF | 10 | TOB07 | TT | CIG01a | 10 | Total Denier | g/9000 m | g/9000 m | 11 | TOB07 | TT | CIG01a | 11 | Filter Density | g/cm3 | g/cm3 | 12 | TOB07 | TT | CIG01a | 12 | Filter Pressure Drop | mm H2O | mm H2O |
This images shows the filtration zone where the ventilation occurs.
Image Removed
Question - is this helpful? Will need permission. This is from the second reference.
References:
Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | IGDCMPID | PTSEQ | PTTESTCD | PTTEST | PTCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTMETHOD | PTREPNUM |
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| 1 | TOB07 | PT | CIG01a |
| | LENGTH | Length | DESIGN PARAMETER TESTING | | mm | | | mm |
| 1 | | 2 | TOB07 | PT | CIG01a |
| 2 | CIRCUMF | Circumference | DESIGN PARAMETER TESTING | 24.9 | mm | 24.9 | 24.9 | mm |
| 1 | | 3 | TOB07 | PT | CIG01a |
| 3 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER TESTING | 779 | mg | 779 | 779 | mg |
| 1 | | 4 | TOB07 | PT | CIG01a |
| 4 | MOISTURE | Moisture | DESIGN PARAMETER TESTING | 13.1 | % | 13.1 | 13.1 | % |
| 1 | | 5 | TOB07 | PT | CIG01a | | 5 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER TESTING | 22 | cuts/in | 22 | 22 | cuts/in |
| 1 | | 6 | TOB07 | PT | CIG01a | | 6 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER TESTING | 27 | mm | 27 | 27 | mm |
| 1 | | 7 | TOB07 | PT | CIG01a |
| 7 | VENTLFLT | Filter Ventilation | DESIGN PARAMETER TESTING | 35 | % | 35 | 35 | % |
| 1 | | 8 | TOB07 | PT | CIG01a |
| 8 | TPNPLGTH | Tipping Paper Length | DESIGN PARAMETER TESTING | 30 | mm | 30 | 30 | mm |
| 1 | | 9 | TOB07 | PT | CIG01a |
| 9 | CBPPOR | Cigarette Base Paper Porosity | DESIGN PARAMETER TESTING | 48 | Cu | 48 | 48 | Cu |
| 1 | | 10 | TOB07 | PT | CIG01a |
| 10 | CBPPERM | Cigarette Base Paper Permeability | DESIGN PARAMETER TESTING | 50 | Cu | 50 | 50 | Cu |
| 1 | | 11 | TOB07 | PT | CIG01a |
| 11 | CPBPOR | Cigarette Paper Band Porosity | DESIGN PARAMETER TESTING | 9.8 | Cu | 9.8 | 9.8 | Cu |
| 1 | | 12 | TOB07 | PT | CIG01a |
| 12 | CPBPERM | Cigarette Paper Band Permeability | DESIGN PARAMETER TESTING | 10 | Cu | 10 | 10 | Cu |
| 1 | | 13 | TOB07 | PT | CIG01a |
| 13 | CPBDIFF | Cigarette Paper Band Diffusivity | DESIGN PARAMETER TESTING | 0.06 | cm2/s | 0.06 | 0.06 | cm2/s |
| 1 | | 14 | TOB07 | PT | CIG01a |
| 14 | CPBWID | Cigarette Paper Band Width | DESIGN PARAMETER TESTING | 7.1 | mm | 7.1 | 7.1 | mm |
| 1 | | 15 | TOB07 | PT | CIG01a |
| 15 | CPBSPC | Cigarette Paper Band Space | DESIGN PARAMETER TESTING | 19.9 | mm | 19.9 | 19.9 | mm |
| 1 | | 16 | TOB07 | PT | CIG01a |
| 16 | FLTREFF | Filter Efficiency | DESIGN PARAMETER TESTING | 28 | % | 28 | 28 | % |
| 1 | | 17 | TOB07 | PT | CIG01a |
| 17 | DPF | Denier Per Filament | DESIGN PARAMETER TESTING | 4.1 |
| 4.1 | 4.1 |
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| 1 | | 18 | TOB07 | PT | CIG01a |
| 18 | TDENIER | Total Denier | DESIGN PARAMETER TESTING | 29900 | g/9000m | 29900 | 29900 | g/9000m |
| 1 | | 19 | TOB07 | PT | CIG01a |
| 19 | FLTRDEN | Filter Density | DESIGN PARAMETER TESTING | 0.1112 | g/cm3 | 0.1112 | 0.1112 | g/cm3 |
| 1 | | 20 | TOB07 | PT | CIG01a |
| 20 | FLTRLGTH | Filter Length | DESIGN PARAMETER TESTING | 25 | mm | 25 | 25 | mm |
| 1 | | 21 | TOB07 | PT | CIG01a |
| 21 | FLTPRDRP | Filter Pressure Drop | DESIGN PARAMETER TESTING | 62 | mm H2O | 62 | 62 | mm H2O |
| 1 | | 22 | TOB07 | PT | CIG01a |
| 22 | TORODDEN | Tobacco Rod Density | DESIGN PARAMETER TESTING | 0.2701 | g/cm3 | 0.2701 | 0.2701 | g/cm3 |
| 1 | | 23 | TOB07 | PT | CIG01a |
| 23 | CIGPLGTH | Cigarette Paper Length | DESIGN PARAMETER TESTING | 53 | mm | 53 | 53 | mm |
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References:
- International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
- Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://wwwdoi.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/org/10.1093/jnci/djx075