13/30259011 DC : 0

Superseded

View Superseded by

BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE

Available format(s)

Hardcopy , PDF

Superseded date

05-31-2014

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Configuration
5 Requirements
6 Package
7 Labelling
8 Transit and storage
Annex A (normative) - Test methods for the intensity
        and sharpness of the tip of the needle
Annex B (informative) - Test methods for the puncture
        performance of the tip of the needle
Annex C (informative) - Test method for resistance to
        corrosion
Bibliography

BS ISO 17218

Committee	CH/100
DocumentType	Draft
Pages	29
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 17218:2014

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 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
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
SAC GB 2024 : 1994	ACUPUNCTURE NEEDLES
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 780:2015	Packaging Distribution packaging Graphical symbols for handling and storage of packages
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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
EN 980:2008	Symbols for use in the labelling of medical devices
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