ISO 20308:2017 PDF

Name: ISO 20308:2017 — Traditional Chinese medicine — Gua Sha instruments
SKU: ISO 20308:2017
Price: 25 EUR
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Traditional Chinese medicine — Gua Sha instruments

Название (английский):

ISO 20308:2017

Traditional Chinese medicine — Gua Sha instruments

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 19 мая 2017 г.
Издание:: ISO IS 20308 edition 1 version 1
ICS:: 11.040.99

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Описание (английский):

ISO20308:2017 specifies appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, biocompatibility of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use. Electro-devices and other forms are outside the scope of this document.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

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:

Scope and exclusions

Applies to physical Gua Sha instruments (various shapes and materials). Electro‑devices and other forms are excluded.

Appearance and shape

Acceptable shapes include oval, rectangle, notch, triangle, comb, fish and others (Annex B gives dimensions and configurations).

Material options

Typical materials: buffalo‑horn, bian‑stone, jade, and other suitable materials.

Visual inspection

Surfaces must be flat, smooth, free from particles, cracks, acute angles or obvious deformation.

Cleaning and disinfection

Processing guidance references ISO 17664 to avoid skin irritation and infection.

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.

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.

Biocompatibility

Assessment and documentation per ISO 10993‑1; compliance may be demonstrated via published data, clinical history, traceability or biological evaluation.

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.

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.

ISO 20308:2017 PDF

Abstract

Похожие стандарты

Overview - ISO 20308:2017 for Gua Sha instruments

Key topics and technical requirements

Practical applications and users

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