BS ISO 20308:2017
Current
The latest, up-to-date edition.
Traditional Chinese medicine. Gua Sha instruments
Hardcopy , PDF
English
03-07-2017
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Appearance
5 Material
6 Requirements
7 Packaging
8 Transport and storage
9 Labelling and instructions for use
Annex A (informative) - Test methods for surface roughness
Annex B (informative) - Dimension and configuration of
Gua Sha instruments
Bibliography
Gives appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, biocompatibility of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use.
| Committee |
CH/100/1
|
| DevelopmentNote |
Supersedes 16/30319982 DC. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document specifies appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, biocompatibility of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use.
Electro-devices and other forms are outside the scope of this document.
| Standards | Relationship |
| ISO 20308:2017 | Identical |
| 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/IEC Guide 37:2012 | Instructions for use of products by consumers |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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