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BS ISO 20308:2017

Current
Current

The latest, up-to-date edition.

Traditional Chinese medicine. Gua Sha instruments
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-03-2017

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.

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.

Committee
CH/100/1
DevelopmentNote
Supersedes 16/30319982 DC. (07/2017)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

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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