This Standard specifies requirements for sterile hypodermic needles for single use of nominal outside diameters 0.3 mm and 1.2 mm.
This Standard is applicable to the hypodermic needles for intracutaneous, subcutaneous, intramuscular and intravenous injection of human body, or extraction of liquor.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
GB/T 1962.1-2001 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 1: General Requirements (idt ISO 594-1:1986)
GB/T 1962.2-2001 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 2: Lock Fittings (idt ISO 594-2:1998)
GB 2828-1987 Sampling Procedures and Tables for Lot-by-lot Inspection by Attributes (Apply to Inspection of Successive Lots or Batches)
GB 2829-1987 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability)
GB 6682-1992 Water for Analytical Laboratory Use — Specification and Test Methods
GB/T 14233.1-1998 Test Methods for Infusion Transfusion Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-1993 Test Methods for Infusion Transfusion Injection Equipments for Medical Use — Part 2: Biological Test Methods
GB/T 16886.1-2001 Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing (idt ISO 10993-1:1997)
GB 18457-2001 Stainless Steel Needle Tubing for the Manufacture of Medical Devices (eqv ISO 9626:1991)
YY 0242-1996 Polypropylene Material for Manufacture of Infusion Transfusion and Injection Equipments for Medical Use
YY/T 0296-1997 Hypodermic Needles for Single Use — Colour Coding for Identification (idt ISO 6009:1992)
YY/T 0313-1998 Package, Label, Transport and Storage for Medical Polymer Products
3 Classification and Nomenclature
3.1 Designation and type of each component of hypodermic needle is shown in Figure 1.
3.2 Geometric drawing and denomination of needle points is shown in Figure 2.
3.3 Product marks: the denomination of hypodermic needles shall be expressed with the external diameter, length, tube wall type and basil angle of needle tube; external diameter and length dimensions expressed in mm; tube wall type expressed with RW (regular wall), TW (thin wall) or ETW (extra thin wall);basil angle expressed with LB (long bevel angle) or SB (short bevel angle).
1 Scope
This Standard specifies requirements for sterile hypodermic needles for single use of nominal outside diameters 0.3 mm and 1.2 mm.
This Standard is applicable to the hypodermic needles for intracutaneous, subcutaneous, intramuscular and intravenous injection of human body, or extraction of liquor.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
GB/T 1962.1-2001 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 1: General Requirements (idt ISO 594-1:1986)
GB/T 1962.2-2001 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 2: Lock Fittings (idt ISO 594-2:1998)
GB 2828-1987 Sampling Procedures and Tables for Lot-by-lot Inspection by Attributes (Apply to Inspection of Successive Lots or Batches)
GB 2829-1987 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability)
GB 6682-1992 Water for Analytical Laboratory Use — Specification and Test Methods
GB/T 14233.1-1998 Test Methods for Infusion Transfusion Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-1993 Test Methods for Infusion Transfusion Injection Equipments for Medical Use — Part 2: Biological Test Methods
GB/T 16886.1-2001 Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing (idt ISO 10993-1:1997)
GB 18457-2001 Stainless Steel Needle Tubing for the Manufacture of Medical Devices (eqv ISO 9626:1991)
YY 0242-1996 Polypropylene Material for Manufacture of Infusion Transfusion and Injection Equipments for Medical Use
YY/T 0296-1997 Hypodermic Needles for Single Use — Colour Coding for Identification (idt ISO 6009:1992)
YY/T 0313-1998 Package, Label, Transport and Storage for Medical Polymer Products
3 Classification and Nomenclature
3.1 Designation and type of each component of hypodermic needle is shown in Figure 1.
3.2 Geometric drawing and denomination of needle points is shown in Figure 2.
3.3 Product marks: the denomination of hypodermic needles shall be expressed with the external diameter, length, tube wall type and basil angle of needle tube; external diameter and length dimensions expressed in mm; tube wall type expressed with RW (regular wall), TW (thin wall) or ETW (extra thin wall);basil angle expressed with LB (long bevel angle) or SB (short bevel angle).
Designation example:
