ISO 19611:2017

Overview

ISO 19611:2017 - Traditional Chinese medicine - Air extraction cupping device - defines safety, performance and packaging requirements for air extraction cupping devices that operate using negative pressure. The standard covers materials, dimensions, pressure performance, sterilization/disinfection, labelling and test methods, and applies to both single‑use and multiple‑use cupping cups. (The suction pump that creates negative pressure is excluded.)

Key topics and technical requirements

• Scope & configuration

  • Defines parts: body, air outlet and one‑way valve; specifies inner volume classes (e.g., 70 ±7 ml, 55 ±5.5 ml, 40 ±4.0 ml, 25 ±2.5 ml, 15 ±1.5 ml).
  • Air outlet must include an outer diameter portion of at least 11 mm.
  • Skin‑contacting edge must be rounded to prevent injury; transparency required to observe skin changes.

• Performance

  • Negative pressure resistance: device must resist a maximum instantaneous negative pressure (specified in the standard).
  • Pressure maintenance: pressure must be maintained over time (standard requires limited pressure loss over 10 minutes).
  • Mechanical stability: maintain pressure after impact testing (0.5 J ±0.05 J).
  • Repeated disinfection resistance: multiple‑use devices must retain performance after repeated disinfection.

• Biological safety

  • Biological evaluation per ISO 10993 series. Required tests vary by type:
    • Both single‑use and multiple‑use: cytotoxicity and sensitization.
    • Single‑use (blood‑contact) additionally: intracutaneous reactivity, acute systemic toxicity, hemocompatibility.
    • Ethylene oxide (EO) residual testing when EO sterilization is used.

• Sterilization & disinfection

  • Single‑use devices: validated sterilization per ISO 11135 / ISO 11137‑1 / ISO 17665‑1.
  • Multiple‑use devices: validated disinfection procedures per ISO 17664.

• Packaging & labelling

  • Primary package must be sealed, free of foreign matter, protect sterility/disinfection and show evidence of opening.
  • Symbols and labelling follow ISO 15223‑1; secondary packaging must protect contents during transport/storage.

Applications and users

ISO 19611 is intended for:

• Manufacturers and designers of cupping devices (product specification, testing and CE/market compliance).
• Quality assurance, regulatory affairs and conformity assessment teams in medical device companies.
• Sterilization and reprocessing specialists defining validated processes.
• Healthcare providers, clinics and procurement teams that purchase single‑use or reusable cupping cups.
• Test laboratories performing performance and biocompatibility testing.

Related standards

• ISO 10993 (biological evaluation)
• ISO 11135, ISO 11137‑1, ISO 17665‑1 (sterilization)
• ISO 17664 (reprocessing information)
• ISO 15223‑1 (symbols on labels)
• ISO 11607‑1 (packaging for terminally sterilized devices)

Keywords: ISO 19611, air extraction cupping device, cupping therapy, traditional Chinese medicine, negative pressure, sterilization, biocompatibility, medical device packaging.