ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles

This document specifies general requirements for the basic safety and essential performance of transcutaneous electrical acupoint stimulators (TEAS) with a focus on devices intended to stimulate acupoints on the human body. It applies to all types of TEAS specifically designed for acupoint-related therapeutic usage, only in the context of professional traditional Chinese medicine (TCM) healthcare services. It is not applicable to invasive electro-acupuncture stimulators for the application of electric currents via acupuncture needles inserted into the body.

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.

This document specifies the requirements and test methods of single-use acupoint magnetotherapy plasters. For devices containing other medicine ingredients, this document only applies to the magnetotherapy functions of the device.

This document specifies safety controls for cupping devices used for air suction or discharge. It applies to cupping devices that contain cups made of manufactured materials, such as plastic, glass, rubber, ceramic or silicone. It does not apply to cupping devices that contain cups made from natural materials (e.g. bamboo) or those that include additional features, such as magnetism or infrared.

This document specifies general requirements for the basic safety and essential performance of electro-acupuncture (EA) stimulators. It is not applicable to acupuncture needles, transcutaneous electrical nerve stimulators or electrical nerve and muscle stimulators.

This document specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. This document is applicable to herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also applies to the decocting part of the integrated apparatus of decoction and package.

This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

This document specifies requirements and test methods for laser acupoint devices. This document is not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the laser features.

This document specifies the performance criteria of peripheral visual instruments in the computerized tongue image analysis system (CTIS), including colour reproduction, distortion and resolution.

This document specifies the requirements for the glass cupping device applying negative pressure created by a heat source placed in its inner cavity. This document includes the requirements for configuration, material, performance, packaging and labelling, as well as appropriate test methods. This document applies to single-use and multiple-use glass cupping devices. This document does not apply to the air extraction cupping device covered by ISO 19611.

This document specifies general requirements for electrical heating moxibustion equipment. It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices covered by ISO 21366.

This document specifies the colour character and appearance of the colour chart used in a computerized tongue image analysis system (CTIS). This document excludes diagnostic or clinical comparison to the colour chart.

This document specifies the requirements and test methods for therapeutic fumigation devices, hereafter referred to as the device. This document does not apply to decoction pieces.

This document specifies general requirements for a computerized tongue image analysis system (CTIS). This document is limited to the safety aspects and technical requirements for a CTIS, excluding the diagnosis or interpretation of tongue images.

This document specifies the general requirements for basic performance and safety of abdominal physiological parameter detectors. It covers the material, basic parameters and testing method of abdominal parameter detectors but does not prescribe the clinical abdominal diagnosis associated with the findings obtained from the devices.

This document describes a method of acquisition of tongue image and expression of tongue colour and coating colour by computerized tongue image analysis system (CTIS). This document does not cover the clinical tongue diagnosis result.

This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

ISO 20495:2018 specifies performance and test methods for skin electrical resistance measurement devices. ISO 20495:2018 is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. ISO 20495:2018 is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

ISO 19614:2017 specifies the technical requirements, classification and test method for a pulse graph force transducer, hereafter referred to as transducer. It only applies to pulse graph acquisition over the patient's radial artery based on TCM pulse condition requirements.

ISO 20498-2:2017 specifies the light environment necessary for the functioning of a computerized tongue image analysis system (CTIS). ISO 20498-2:2017 does not include the electrical safety and biocompatibility of the lighting component.

This document provides sample preparation method and provide test result of smoke density test for smokeless moxibustion devices specified in the Annex B of ISO 21366 General requirements for smokeless moxibustion devices. This document contains sample preparation methods in accordance with the shape of smokeless moxibustion device and smoke density of moxa wool, carbonized moxa wool and smokeless moxibustion device products.

This document provides a procedure for reporting indoor air quality safety when combusting moxibustion devices by comparing indoor concentration values of pollutants among combustion products with international, regional or national ambient/indoor air quality regulations, standards, or guideline values. This document does not apply to moxibustion devices that do not involve combustion, such as electric heating moxibustion equipment covered in ISO 21292:2020 and infrared moxibustion-like instrument covered in ISO 20493:2018.

This document specifies the general requirements for basic safety and essential performance of electric radial pulse tonometric devices. This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic data obtained from the use of such devices. This document applies to pressure-based radial pulse tonometric devices.

This document specifies general requirements to ensure the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.

ISO 18666:2015 specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that uses moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. ISO 18666:2015 does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

ISO 18665.2015 specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. It is applicable to the herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also applies to the decocting part of the integrated apparatus of decoction and package.