ISO 18666:2021 PDF

Scope: 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.

ISO 18666:2021 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements

2021 ISO 18666:2021 Traditional Chinese medicine — General requirements of moxibustion devices
2015 ISO 18666:2015 Traditional Chinese medicine - General requirements of moxibustion devices