Overview
ISO 22587:2023 specifies requirements and test methods for single‑use acupoint magnetotherapy plasters used in Traditional Chinese Medicine (TCM). The standard covers the magnetotherapy function of plasters that contain permanent magnets and applies where products also include other medicinal ingredients - limited to their magnetic function. It defines material, appearance, magnetic strength, adhesion, geometry, biological evaluation, packaging, labelling and instructions for use.
Keywords: ISO 22587:2023, acupoint magnetotherapy plasters, Traditional Chinese Medicine, single‑use magnet plasters, magnetic field strength.
Key topics and technical requirements
- Magnetic field strength: Target maximum magnetic field strength range 35 mT to 400 mT; measurement error must not exceed 5%. Manufacturers must declare maximum field strength and flux shape.
- Magnetic field leakage: If average maximum field strength exceeds 60 mT at 5 mm from the magnet surface, this must be stated on the package or instructions.
- Adhesion: Adhesive between plaster and permanent magnet must be at least 10 times the magnet’s weight; plaster–skin adhesion tested per ISO 29862.
- Geometry: Plaster dimensions must be more than double the permanent magnet’s dimensions. Permanent magnet minimum diameter ≥ 1 mm (or minimum cross‑sectional area ≥ 1 mm² for special shapes).
- Material & appearance: Manufacturers must declare magnet material in line with IEC 60404‑8‑1; magnets must be free of sharp edges and burrs.
- Biological evaluation: Skin‑contact parts must meet biocompatibility assessment per ISO 10993‑1.
- Packaging & labelling: Sealed, non‑resealable packaging that protects contents; labelling to conform with ISO 15223‑1 and include manufacturer, contents, LOT, manufacture/expiry date (if sterile), “single use” statement, and polarity/position marking.
- Test methods: Use gauss meters for magnetic strength; a spherical non‑magnetic case method is specified for leakage measurements; adhesion and geometry inspection procedures defined.
Applications and users
- Practical use: Ensures safety, performance and traceability of single‑use acupoint magnetotherapy plasters applied to acupuncture points for therapeutic magnetic stimulation.
- Who uses it:
- Manufacturers and product designers of TCM magnetotherapy plasters
- Regulatory bodies and conformity assessors
- Quality and R&D teams performing product testing and labelling
- Clinical practitioners and TCM clinics selecting compliant single‑use magnet plasters
Related standards
- ISO 10993‑1 - Biological evaluation of medical devices
- ISO 29862 - Self‑adhesive tapes - Peel adhesion properties
- IEC 60404‑8‑1 - Magnetic materials (magnetically hard)
- ISO 8124‑1 - Safety aspects related to mechanical/physical properties (referenced for precautions)
- ISO 15223‑1 - Medical device symbols for labelling
This concise summary helps manufacturers and practitioners understand ISO 22587:2023 requirements for safe, effective single‑use acupoint magnetotherapy plasters and supports compliant product design, testing and labelling.