This standard specifies the requirements for sterile hypodermic needles for single use (hereinafter referred to as hypodermic needle) with nominal outside diameter of 0.3mm~1.2mm.
The hypodermic needle specified in this standard is for auxiliary use with the sterile hypodermic syringes for single use in GB 15810 and also suitable for other appropriate injection equipment and used for injecting chemical liquid to intracutaneous, subcutaneous, muscle, and vein etc. of human body.
This standard is not applicable to dental hypodermic needles for single use.
The hypodermic needles for single use for matching with sterile hypodermic syringes for single use in non-sterile state may refer to this standard.
2 Normative References
The following documents for the application of this document are essential. Any dated reference, just dated edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1962.1-2015 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement (ISO 594-1:1986, IDT)
GB/T 1962.2-2001 The Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings (ISO 594-2:1998, IDT)
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods (GB/T 6682-2008, ISO 3696:1987:MOD)
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods
GB 15810 Sterile Hypodermic Syringes for Single Use (GB 15810-200, eqv ISO 7886-1:1993)
GB/T 16886.1 Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing Within a Risk Management Process (GB/T 16886-2011, ISO 10993-1:2009, IDT)
GB/T 18457-2015 Stainless Steel Needle Tubing for the Manufacture of Medical Devices (ISO 9626:1991, MOD)
YY/T 0296 Hypodermic Needles for Single Use - Colour Coding for Identification (YY/T 0296-2013, ISO 6009:1992, IDT)
YY/T 0466.1 Devices - Symbols to be Used With Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements (YY/T 0466.1-2009, ISO 15233-1:2007, IDT)
3 Structural Type and Nomenclature
Foreword i 1 Scope 2 Normative References 3 Structural Type and Nomenclature 4 Example of Labelling 5 Materials 6 Physical Performance 7 Chemical Performance 8 Biological Performance 9 Packaging 10 Marking 11 Inspection Rules 12 Storage Appendix A (Informative) Flow Test Device Appendix B (Informative) Test and Assessment Method for Penetration Force of Hypodermic Needle Appendix C (Normative) Biological Evaluation Appendix D (Informative) Inspection Rules References
1 Scope
This standard specifies the requirements for sterile hypodermic needles for single use (hereinafter referred to as hypodermic needle) with nominal outside diameter of 0.3mm~1.2mm.
The hypodermic needle specified in this standard is for auxiliary use with the sterile hypodermic syringes for single use in GB 15810 and also suitable for other appropriate injection equipment and used for injecting chemical liquid to intracutaneous, subcutaneous, muscle, and vein etc. of human body.
This standard is not applicable to dental hypodermic needles for single use.
The hypodermic needles for single use for matching with sterile hypodermic syringes for single use in non-sterile state may refer to this standard.
2 Normative References
The following documents for the application of this document are essential. Any dated reference, just dated edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1962.1-2015 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement (ISO 594-1:1986, IDT)
GB/T 1962.2-2001 The Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings (ISO 594-2:1998, IDT)
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods (GB/T 6682-2008, ISO 3696:1987:MOD)
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods
GB 15810 Sterile Hypodermic Syringes for Single Use (GB 15810-200, eqv ISO 7886-1:1993)
GB/T 16886.1 Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing Within a Risk Management Process (GB/T 16886-2011, ISO 10993-1:2009, IDT)
GB/T 18457-2015 Stainless Steel Needle Tubing for the Manufacture of Medical Devices (ISO 9626:1991, MOD)
YY/T 0296 Hypodermic Needles for Single Use - Colour Coding for Identification (YY/T 0296-2013, ISO 6009:1992, IDT)
YY/T 0466.1 Devices - Symbols to be Used With Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements (YY/T 0466.1-2009, ISO 15233-1:2007, IDT)
3 Structural Type and Nomenclature
Contents of GB 15811-2016
Foreword i
1 Scope
2 Normative References
3 Structural Type and Nomenclature
4 Example of Labelling
5 Materials
6 Physical Performance
7 Chemical Performance
8 Biological Performance
9 Packaging
10 Marking
11 Inspection Rules
12 Storage
Appendix A (Informative) Flow Test Device
Appendix B (Informative) Test and Assessment Method for Penetration Force of Hypodermic Needle
Appendix C (Normative) Biological Evaluation
Appendix D (Informative) Inspection Rules
References
