GB 15811-2016: Sterile hypodermic needles for single use

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Scope

This Standard specifies the requirements for sterile hypodermic needles for
single use of which the nominal outer diameters of needle tube are 0.3mm ~
1.2mm (hereinafter referred to as syringe needles).
The syringe needles specified in this Standard shall be matched with sterile
hypodermic needles for single use of GB 15810.They are also suitable for
other appropriate injection equipment, as human skin, subcutaneous, muscle,
vein and other liquid injections.
This Standard is not applicable to disposable dental needles.
The sterile hypodermic needles for single use of disposable sterile syringes in
non-sterile state shall refer to this Standard.

Basic Data

Standard ID	GB 15811-2016 (GB15811-2016)
Description (Translated English)	Sterile hypodermic needles for single use
Sector / Industry	National Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	17,158
Date of Issue	2016-06-14
Date of Implementation	2018-01-01
Older Standard (superseded by this standard)	GB 15811-2001
Quoted Standard	GB/T 1962.1-2015; GB/T 1962.2-2001; GB/T 6682; GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15810; GB/T 16886.1; GB/T 18457-2015; YY/T 0296; YY/T 0466.1
Adopted Standard	ISO 7864-1993, NEQ
Regulation (derived from)	National Standard Announcement No. 8 of 2016
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the requirements for disposable sterile injection needles (hereinafter referred to as injection needles) with a nominal outer diameter of 0.3 mm to 1.2 mm. The standard needle injection is a sterile syringe with GB 15810 supporting the use of disposable, but also suitable for supporting the use of other appropriate injection equipment, as the human skin, subcutaneous, muscle, intravenous injection with liquid. This standard does not apply to single-use dental needles. Non-sterile state for single-use sterile syringe with a one-time use of syringes can refer to this standard.