ISO 22213:2020 PDF

Overview

ISO 22213:2020 specifies requirements for glass cupping devices used in Traditional Chinese Medicine (TCM) that create negative pressure by heating the cup’s inner cavity. The standard covers configuration, dimensions, materials, performance, packaging and labelling, and appropriate test methods for single‑use and multiple‑use glass cupping devices. It excludes air‑extraction cupping devices (see ISO 19611).

Keywords: ISO 22213:2020, glass cupping device, cupping therapy, Traditional Chinese Medicine, negative pressure, borosilicate glass.

Key topics and technical requirements

• Configuration & dimensions
  • Cups are produced in five numeric sizes (1–5).
  • Inner cavity volumes: Cup 1: 340 ± 17 ml, 2: 260 ± 13 ml, 3: 180 ± 9 ml, 4: 130 ± 6.5 ml, 5: 95 ± 4.8 ml.
  • Glass thickness specified per cup (e.g., Cup 1: 7.50 ± 0.4 mm, Cup 5: 4.70 ± 0.2 mm).
• Material
  • Made from borosilicate glass conforming to ISO 3585.
• Performance
  • Negative pressure resistance: must resist instantaneous pressure of ≥ −91.50 kPa without cracking.
  • Pressure maintenance: pressure loss between cup and skin not more than 10% over 10 minutes under defined test conditions.
  • Test methods (Annex A) use a T‑shaped valve, suction pump, manometer and a silicon plate to measure instantaneous and sustained negative pressures (instantaneous test up to −95.10 kPa; maintenance range −54.57 to −62.38 kPa).
• Quality & biocompatibility
  • Surface smoothness: external surface, lip and top must be smooth and free of burrs.
  • Glass quality limits on impurities and bubble sizes (detailed in the standard).
  • Biological evaluation per ISO 10993 series (selection, irritation, chemical characterization).
• Packaging & labelling
  • Primary sealed packaging with no foreign matter; clear labelling (manufacturer, product name, size, lot/registration number, manufacture date, integrity warning).
  • Secondary and transit packaging requirements and “Fragile” marking.

Applications and users

• Manufacturers of glass cupping devices (design, production, QA)
• Medical device regulatory authorities and conformity assessors
• Testing and certification laboratories (mechanical and biocompatibility tests)
• Packaging suppliers and sterilization service providers
• TCM clinics, hospitals and procurement teams seeking compliant devices for safe cupping therapy

Related standards

• ISO 3585 (borosilicate glass)
• ISO 10993‑1, ‑4, ‑10, ‑18 and ISO/TS 10993‑19 (biological evaluation)
• ISO 15223‑1 (medical device symbols)
• ISO 17664 (processing/sterilization information)
• ISO 11607‑1 (packaging for terminally disinfected devices)
• Exclusion: ISO 19611 (air extraction cupping devices)

This summary helps stakeholders understand ISO 22213:2020 for product design, testing, regulatory compliance and safe clinical use of glass cupping devices.