Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

15-08-2016

Publisher

International Organization for Standardization

ISO 18746:2016 specifies the requirements of sterile intradermal acupuncture needle for single use as a medical device, including the following factors:

a) size;

b) material;

c) quality;

d) testing methods;

e) packing;

f) identification.

DevelopmentNote	Supersedes ISO/DIS 18746. (08/2016)
DocumentType	Standard
Pages	9
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
NEN ISO 18746 : 2016	Identical
BS ISO 18746:2016	Identical

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2007/47/EC : 2007 COR 1 2015	DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
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ISO 11138-2:2017	Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
SAC GB 2024 : 1994	ACUPUNCTURE NEEDLES
ISO 780:2015	Packaging Distribution packaging Graphical symbols for handling and storage of packages
SAC GB/T 1031 : 1995	GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - SURFACE TEXTURE: PROFILE METHOD - SURFACE ROUGHNESS PARAMETERS AND THEIR VALUES
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 14971:2007	Medical devices Application of risk management to medical devices
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