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  • ISO 18746:2016

    Current The latest, up-to-date edition.

    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

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    Abstract - (Show below) - (Hide below)

    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.

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

    Development Note Supersedes ISO/DIS 18746. (08/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

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

    ISO 6507-1:2005 Metallic materials Vickers hardness test Part 1: Test method
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10282:2014 Single-use sterile rubber surgical gloves — Specification
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 6507-4:2005 Metallic materials Vickers hardness test Part 4: Tables of hardness values
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 17218:2014 Sterile acupuncture needles for single use
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 15510:2014 Stainless steels Chemical composition
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 6507-2:2005 Metallic materials Vickers hardness test Part 2: Verification and calibration of testing machines
    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)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 6507-3:2005 Metallic materials Vickers hardness test Part 3: Calibration of reference blocks
    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
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
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