ISO/TS 25427:2026

Technical
Specification
ISO/TS 25427
First edition
Traditional Chinese medicine —
2026-09
Chuzhen instruments
Médecine traditionnelle chinoise — Instruments Chuzhen
Reference number
© ISO 2026
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Structure and dimension . 2
4.1 Structure .2
4.2 Dimension .3
5 General requirements . 6
5.1 Appearance .6
5.2 Materials .6
5.3 Hardness .6
5.4 Mechanical strength .6
5.5 Mass .6
5.6 Roughness .6
5.7 Abrasion resistance . . .7
5.8 Corrosion resistance .7
5.9 Cleanliness and disinfection .7
5.10 Safety requirements .7
6 Test methods . 7
6.1 Test method for dimension .7
6.2 Test method for appearance .7
6.3 Test method for material .8
6.4 Test method for hardness .8
6.5 Test method for mechanical strength .8
6.6 Test method for mass . .8
6.7 Test method for roughness .8
6.8 Test method for abrasion resistance .8
6.9 Test method for corrosion resistance .8
7 Packaging, transmit and storage . 8
7.1 Packaging .8
7.1.1 Primary packaging .8
7.1.2 Secondary packaging.9
7.1.3 Storage or transport packaging .9
7.2 Labelling and instructions for use .9
7.2.1 Primary packaging .9
7.2.2 Secondary packaging.9
7.2.3 Instructions of use .9
7.3 Transmit and storage .10
Bibliography .11

iii
Foreword
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iv
Introduction
Non-invasive meridian and acupoint stimulators are essential external instruments of traditional Chinese
medicine, with a rich historical background, diverse typology, and a thriving global market.
As a commonly utilized non-invasive meridian and acupoint stimulation instrument, the Chuzhen
instrument stimulates acupoints, meridians, muscles and fascia through manipulations such as tapping,
pressing, scraping, and rotating to prevent and treat diseases. Currently, it has been used in Germany, the
Netherlands, France, China, Malaysia, South Africa and other countries.
The safety and quality of Chuzhen instruments are closely linked to the safety and efficacy of Chuzhen
therapy. Currently, there is a wide variety of Chuzhen instruments available on the market, presenting issues
such as excessive sharpness at the tip, high surface roughness, and immature structural design. However,
there is no standardized guidance for their manufacturing and processing. This lack of standardization
poses potential safety risks and raises concerns among operators and consumers. Standardizing Chuzhen
instruments enhances their safety and quality, and promotes more scientific, safe, and effective global use of
Chuzhen instruments.
v
Technical Specification ISO/TS 25427:2026(en)
Traditional Chinese medicine — Chuzhen instruments
1 Scope
This document specifies the general requirements and test methods of Chuzhen instruments.
It is only applicable to non-disposable Chuzhen instruments.
It is not applicable for any disposable Chuzhen instruments or for those with electrical, heat-storing, or other
special characteristics.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9227, Corrosion tests in artificial atmospheres — Salt spray tests
ISO 10993-1, Biological evaluation of medical devices — Part 1: Requirements and general principles for the
evaluation of biological safety within a risk management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-23, Biological evaluation of medical devices — Part 23: Tests for irritation
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
IEC 60335-2-32, Household and similar electrical appliances — Safety — Part 2-32: Particular requirements for
massage appliances
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
non-invasive
designed for application on the body surface without penetration of the skin
3.2
reusable device
device designed to be used multiple times, follow appropriate reprocessing procedures between uses, and to
maintain its safety and performance throughout its intended service life

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