Overview - ISO 20308:2017 for Gua Sha instruments
ISO 20308:2017, titled Traditional Chinese medicine - Gua Sha instruments, is an international standard published by ISO that defines safety, performance and information requirements for non‑electrical Gua Sha tools. The standard’s objective is to guarantee safety and performance, support regulatory compliance and promote international trade and clinical application of Gua Sha therapy.
Key topics and technical requirements
ISO 20308:2017 addresses design, materials, testing and information obligations. Major technical topics include:
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Scope and exclusions
- Applies to physical Gua Sha instruments (various shapes and materials). Electro‑devices and other forms are excluded.
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Appearance and shape
- Acceptable shapes include oval, rectangle, notch, triangle, comb, fish and others (Annex B gives dimensions and configurations).
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Material options
- Typical materials: buffalo‑horn, bian‑stone, jade, and other suitable materials.
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Visual inspection
- Surfaces must be flat, smooth, free from particles, cracks, acute angles or obvious deformation.
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Cleaning and disinfection
- Processing guidance references ISO 17664 to avoid skin irritation and infection.
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Mechanical and surface properties
- Hardness: ≥ Moh’s hardness 3.
- Surface roughness: after polishing ≤ 6.3 µm (test methods in Annex A).
- Resistance to abrasion: able to withstand 150 cycles of repeated disinfection; no pre‑expiry abrasion if storage requirements met.
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Radiological safety
- Limits and calculation methods for internal and external exposure indices (Ra‑226, Th‑232, K‑40). Internal index ≤ 0.5; external index ≤ 0.65.
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Biocompatibility
- Assessment and documentation per ISO 10993‑1; compliance may be demonstrated via published data, clinical history, traceability or biological evaluation.
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Packaging, transport & storage
- Primary packaging must be sealed, protect contents and show tamper evidence; secondary packaging must protect during transit. Storage: clean, dry, ventilated, protect from humidity, heat and sunlight.
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Labelling & instructions for use (IFU)
- Primary/secondary labelling requirements (manufacturer, lot, expiry, material, dimensions, single‑use marking, handling). IFU per ISO/IEC Guide 37: product description, license/standard numbers, performance, indications/contraindications, disinfection and precautions.
Practical applications and users
ISO 20308:2017 is useful to:
- Manufacturers and product designers - for material selection, shape standards, surface finish and durability testing.
- Quality assurance and testing labs - to develop inspection criteria and test protocols (roughness, hardness, radiological indices, abrasion).
- Regulatory and compliance teams - to prepare labelling, IFU and biocompatibility documentation aligned with ISO 10993‑1 and ISO 17664.
- Importers, distributors and clinicians - to verify packaging, storage and safety information to reduce infection and radiological risks.
Related standards referenced include ISO 17664 (processing information), ISO 10993‑1 (biological evaluation) and ISO/IEC Guide 37 (instructions for use).
Keywords: ISO 20308:2017, Gua Sha instruments, Traditional Chinese Medicine, biocompatibility, surface roughness, Moh’s hardness, ISO 17664, ISO 10993‑1, labelling, packaging.