ISO 21366:2019 PDF

Name: ISO 21366:2019 — Traditional Chinese medicine — General requirements for smokeless moxibustion devices
SKU: ISO 21366:2019
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Traditional Chinese medicine — General requirements for smokeless moxibustion devices

Название (английский):

ISO 21366:2019

Traditional Chinese medicine — General requirements for smokeless moxibustion devices

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 10 мая 2019 г.
Издание:: ISO IS 21366 edition 1 version 1
ICS:: 11.040.99

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 21366:2019 "Traditional Chinese medicine - General requirements for smokeless moxibustion devices" defines performance, safety and testing requirements for combustion‑type devices that claim to provide smokeless moxibustion. The standard is applicable to devices using moxa or carbonized herbal materials as the main combustion material, and excludes non‑combustion imitators such as electro‑ or infrared moxibustion. Its goal is to protect indoor air quality, patient safety and product reliability for modern moxibustion devices.

Key Topics and Requirements

Scope and definitions: Clarifies terms such as moxibustion device, smokeless moxibustion device, smoke density, tVOC, aldehyde and others.

Smoke density and generation tests: Test methods are provided (Annex B and C) to determine whether a product can be labelled “smokeless” based on measured smoke density and smoke generation behavior.

Noxious gas emissions: Emission testing requirements cover carbon monoxide (CO), nitrogen dioxide (NO2), total volatile organic compounds (tVOCs) and aldehydes. Measurement methods reference established standards (e.g., ISO 15011‑2 for CO/NO2, ISO 16000‑6 for tVOCs, ISO 16000‑4 for aldehydes).

Moxibustion temperature and materials: Temperature performance and biocompatibility of materials in contact with the body follow requirements in ISO 18666:2015.

Packaging and labelling: Use of the statement “smokeless” is restricted to devices that meet the standard’s test criteria. Packaging must protect products from damage (protection performance referenced to ISO 2248).

Indoor air quality alignment: Annex A summarizes WHO indoor air quality guidelines (particulate matter, VOCs, formaldehyde, CO, NO2) as reference values for acceptable emissions.

Practical Applications and Who Uses This Standard

ISO 21366 is intended for:

Manufacturers and product designers developing combustion‑type smokeless moxibustion devices to ensure performance, safety and market claims.

Testing laboratories carrying out smoke density, emissions and temperature tests to verify compliance.

Regulatory bodies and conformity assessors evaluating safety, labelling and indoor air quality impacts.

Healthcare providers and procurement teams (TCM clinics, hospitals, wellness centers) that need objective criteria when selecting smokeless moxibustion products.

Quality and compliance managers documenting product claims and packaging requirements.

Practical uses include product development, pre‑market safety testing, supplier audits, labelling verification and procurement specifications to reduce moxibustion smoke, odour and harmful emissions while meeting recognized indoor air quality benchmarks.

Related Standards

ISO 18666:2015 (moxibustion device general requirements)

ISO 15011‑2, ISO 16000‑4, ISO 16000‑6 (emissions and sampling methods)

ISO 2248, ISO 5659‑2 and ISO 7240 series (testing and smoke measurement methods)

Keywords: ISO 21366, smokeless moxibustion devices, moxibustion smoke, indoor air quality, noxious gas, smoke density, traditional Chinese medicine, tVOCs, WHO guidelines.

ISO 21366:2019 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Practical Applications and Who Uses This Standard

Related Standards

Технические детали

ISO 18666:2015

Traditional Chinese medicine — General requirements of moxibustion devices

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SIST EN ISO 5659:2026

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ISO 7240-24:2010/Amd 1:2013

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