BS ISO 18666:2015
Current
The latest, up-to-date edition.
Traditional Chinese medicine. General requirements of moxibustion devices
Hardcopy , PDF
English
30-11-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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
Defines the general requirements for configuration, materials, performance and safety requirements of moxibustion devices.
| Committee |
CH/100
|
| DevelopmentNote |
Supersedes 15/30281262 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| ISO 18666:2015 | Identical |
| 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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