ISO 18746:2016
Current
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
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
| 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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