1. Shirt Size: Must fit the size range between a standard medium male and standard medium female according to ASTM (American Society for Testing and Materials) standards.
  2. Machine Washable: Must withstand being washed with conductive fabric-friendly detergent for at least 365 washes.
  3. Waterproof: Must withstand the pressure of being submerged in at least 114.3 cm of water for at least an hour.
  4. Electrical Component Removal: Must be easily removed by a person with at least 6th grade level physical and cognitive abilities within 1 minute.
  5. Monitor Battery Life: Monitor must be able to hold charge for at least 10 hours.
  6. Connector Security: Connectors must stay securely attached for at least 12 hours.
  7. Connector Usage: Electronics connectors must withstand being removed and reattached at least 1100 times (3 times a day for a year).
  8. Signal Quality from Connectors: Connectors must provide an uninterrupted signal.
  9. Data Collection Mode: Data collected through a 3 lead ECG.
  10. PCB Size: Must be less than 40 cm2.
  11. Sweat Resistant: Must be functional after exposure to sweat for at least 12 hours.
  12. Biocompatibility: No presence of skin irritation on patients after at least 12 hours.
  13. Signal Reading from Electrodes: Electrodes must provide a clear and uninterrupted signal without the use of conductive gel.
  14. Data Storage: ECG data must be wirelessly transmitted to an existing database and data visualization software.
  15. Patient Confidentiality: Data storage and transmission must be HIPAA compliant.
  16. Allergen Friendly: Shirt material must be hypoallergenic.

ASTM Sizes

Below are the standard size ranges for medium bodies according to the ASTM. Sizes range from a standard medium female to a standard medium male.

LocationMeasurement (cm)
Bust Circumference91.44 – 101.6
Waist Circumference71.12 – 87.63
Upper Arm Circumference28.58 – 33.66
Arm Length Center Neck Back78.74 – 84.15
Across Shoulder39.37 – 45.09
Across Back38.1 – 42.23
Back Waist Length41.91 – 45.72
Neck Circumference at Base37.15 – 42.23
Standard Tables of Body Measurements for Mature Men, Ages 35 and Older, Sizes Thirty-Four to Fifty-Two (34 to 52) Short, Regular, and Tall1. https://www.doc.tajhizkala.ir/.