• BS ISO 18666:2015

    Current The latest, up-to-date edition.

    Traditional Chinese medicine. General requirements of moxibustion devices

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2015

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Configuration
    5 Materials
    6 Moxibustion temperature
    7 Safety requirements
    8 Packaging
    9 Labelling
    10 Transport and storage
    11 Instructions for use (to be provided by the
       manufacturer)
    Annex A (informative) - Test methods to determine the
            moxibustion temperature
    Annex B (informative) - Method of artificial drying of
            mugwort leaves by heat
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the general requirements for configuration, materials, performance and safety requirements of moxibustion devices.

    Scope - (Show below) - (Hide below)

    This International Standard 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.

    This International Standard 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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/100
    Development Note Supersedes 15/30281262 DC. (11/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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