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15/30282343 DC : 0

NA

NA

Status of Standard is Unknown

BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES

Available format(s)

Hardcopy , PDF

Language(s)

English

US$26.05
Excluding Tax where applicable

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Structure and dimension of intradermal
  acupuncture needles
5 Materials
6 Performance requirements
7 Packing and Identification
Bibliography

BS ISO 18746.

Committee
CH/100
DocumentType
Draft
Pages
18
PublisherName
British Standards Institution
Status
NA

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 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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