ISO 5227:2022

Overview

ISO 5227:2022 - Traditional Chinese medicine - Safety controls for cupping devices - defines safety controls for cupping devices used for air suction or discharge. It covers devices with cups made from manufactured materials (plastic, glass, rubber, ceramic, silicone) and sets requirements for design, sterilization, cleaning, packaging, labeling and disposal. Devices made from natural materials (e.g., bamboo) or those with additional features (magnetism, infrared) are excluded.

Key Topics

• Scope and definitions: Applies to dry cupping (intact skin) and wet cupping (skin pricked to extract blood). Defines a cupping device as cups plus means of air suction/discharge (pump, fire, bulb, rotary).
• Design & manufacture: Devices must be designed and manufactured to be safe for practitioner and patient and comply with ISO 19611 and ISO 22213.
• Reuse restrictions:
  • Wet cupping devices: single-use only.
  • Dry cupping devices: may be reused after cleaning and disinfection.
• Sterility & sterilization: Pre-sterilized devices for wet cupping must be sterile before use; if sterility is compromised they must be resterilized per ISO 14937 either inside or outside the clinic.
• Cleaning & disinfection: Dry cupping devices require cleaning and disinfection according to manufacturer instructions in line with ISO 17664-2.
• Packaging & labeling: Package integrity per ISO 11607-1; labels and manuals must include product name, manufacturer details, lot number/date, sterilization method and expiry (if applicable), disinfection instructions and handling/storage information.
• Visual inspection & verification: Sampling and visual testing for defects; practitioners should verify safety controls (Annex A checklist).
• Post-use handling:
  • Wet cupping devices: dispose immediately in medical waste containers.
  • Dry cupping devices: place in dedicated container and clean/disinfect before reuse.

Applications

ISO 5227:2022 is practical for:

• Manufacturers designing and producing cupping devices to meet international safety expectations.
• Clinic operators and practitioners developing SOPs for safe use, sterilization, cleaning, and disposal.
• Procurement and quality teams verifying packaging, labeling, lot traceability and manufacturer claims.
• Regulatory authorities and auditors assessing conformance with infection-control and medical device requirements.
• Outsourced sterilization services ensuring processes meet ISO 14937 when resterilizing compromised items.

Related Standards

Normative and referenced standards include:

• ISO 19611, ISO 22213 (cupping device design)
• ISO 11607-1 (packaging for terminally sterilized medical devices)
• ISO 14937 (sterilization process requirements)
• ISO 17664-2 (processing information for non-critical devices) Additional guidance: ISO 13485, ISO 14971, ISO/IEC Guide 51 and Guide 63.

Keywords: ISO 5227:2022, cupping devices, Traditional Chinese medicine, safety controls, wet cupping, dry cupping, sterilization, disinfection, packaging, medical waste.