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GB 15810-2001 English PDF (GB15810-2001)

GB 15810-2001 English PDF (GB15810-2001)

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GB 15810-2001: Sterile hypodermic syringes for single use

This Standard specifies classification and nomenclature, requirements, test methods, inspection rules, packing and labeling of sterile hypodermic syringes for single use. This Standard is applicable to the manual syringes intended for the aspiration of fluids or for the injection of fluids immediately after filling.
GB 15810-2001
(Translator?€?s reminder. There is 1 Amendment included)
Legend / Track Changes.
Text in BLACK. Translated from the original Chinese text.
Text in RED. Integrated / Modified / Digested according to the ?€?No. 1
Amendment [2003]?€?.
GB
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 11. 040. 20
C 31
eqv ISO 7886-1.1993
Sterile Hypodermic Syringes for Single Use
ISSUED ON. SEPTEMBER 18, 2001
IMPLEMENTED ON. FEBRUARY 1, 2002
Issued by. General Administration of Quality Supervision, Inspection
and Quarantine of the People's Republic of China
Table of Contents
Foreword ... 3
ISO Foreword ... 4
Introduction ... 6
1 Scope ... 7
2 Normative References ... 7
3 Definitions ... 8
4 Classification and Nomenclature ... 8
5 Requirements ... 10
6 Test Methods ... 16
7 Packaging ... 19
8 Labelling ... 20
9 Storage ... 21
Appendix A ... 22
Appendix B ... 25
Appendix C ... 27
Appendix D ... 29
Appendix E ... 30
Appendix F ... 31
No.1 Amendment of GB 15810-2001 ... 32
Foreword
This Standard equivalently adopts ISO 7886-1.1993 "Sterile Hypodermic Syringes for Single Use - Part 1. Syringes for Manual Use". this Standard is the revision of GB 15810-1995.
Compared with ISO 7886-1.1993, the main technical differences in this Standard are as follows.
In this Standard, cytoxicity, sensitization, irritation, hemolysis and acute systemic toxicity were supplemented in sterile, pyrogen and biological evaluation of biological performance; requirements on reducing substances (oxidizable substances) in chemical performance were changed from part of Appendix F (Informative) of ISO 7886-1.1993 into an indispensable part of this Standard; Appendix G (Informative) of ISO 7886-1.1993 was changed into an indispensable part of this Standard; add the residue content of epoxy ethane; add Appendix C Inspection Rules. In this Standard, editorial changes had been made on Appendixes A to J of ISO 7886-1.1993; and the Guideline of Material and Bibliography were reserved.
Compared with GB/T 15810-1995, the main technical differences of this Standard are as follows.
In this Standard, according to the requirements of GB/T 16886.1-1997, the provisions of acute systemic toxicity was add in biological performance; abnormal toxicity was deleted; sterile, pyrogen free, hemolysis and intracutaneous irritation in former national standard were reserved; cytoxicity and sensitization were supplemented. Requirements on residue content of epoxy ethane were supplemented in chemical performance. Capacity permissible error is in accordance with international standards. This Standard replaces GB 15810-1995, from the implementation date.
Appendixes A, B, C and D of this Standard are normative.
Appendixes E and F of this Standard are informative.
This Standard was proposed by the State Drug Administration (SDA).
This Standard shall be under the jurisdiction of National Technical Committee 95 on Injector for Medical Purpose of Standardization Administration of China. Drafting organization of this Standard. SDA-Shanghai Quality Supervision and Inspection Center for Medical Devices.
Main drafters of this Standard. Fu Guobao, and Zhao Jing.
This Standard was first-time issued in 1987, and first-revised in 1995. Sterile Hypodermic Syringes for Single Use
1 Scope
This Standard specifies classification and nomenclature, requirements, test methods, inspection rules, packing and labeling of sterile hypodermic syringes (hereinafter referred to as "syringes") for single use.
This Standard is applicable to the manual syringes intended for the aspiration of fluids or for the injection of fluids immediately after filling.
This Standard is not applicable to syringes for use with insulin, single-use syringes made of glass, syringes with needles permanently attached, syringes for use with power-driven syringe pumps, syringes pre-filled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. 2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this 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 Equipment for Medical Use - Part 1. Chemical Analysis Methods
5 Requirements
5.1 Appearance
5.1.1 When inspected by vision under an illumination of 300 lx to 700 lx, the hypodermic syringes shall be clean, free from particles and extraneous matter. 5.1.2 Hypodermic syringes shall be free from any defect of rough selvedge, burrs, creeping and breakage.
5.1.3 The barrel of hypodermic syringe shall be with adequate transparency and able to see the fiducial line clear.
5.1.4 The interior surface (including rubber piston) of hypodermic syringe shall be free from any obvious lubricant droplets or particles.
5.2 Graduated scale of hypodermic syringes
5.2.1 The syringe shall have either only one scale or more than one identical scales, which shall be graduated at least at the intervals given in Table 1.
5.2.2 If the scale is extended beyond the nominal capacity, the extended portion shall be differentiated from the rest of the scale. Examples of means of differentiation are.
a) encircling the scale number of the nominal capacity line;
b) the use of smaller scale numbers for the extra graduation lines;
c) the use of shorter graduation lines for the extra graduation lines;
d) the use of a broken line for the optional vertical line of the extra scale length. 5.3 Graduation lines of graduated scale
5.3.1 The graduation lines shall be numbered at the volume increments given in Table 2 Table 1.
5.3.2 The graduation lines shall be laid in planes at right angles to the axis of the barrel. When the plunger is fully inserted, that is as near to the nozzle end of the barrel as it will go, the zero graduation line of the scale shall coincide with the fiducial line on the piston to within a quarter of the smallest scale interval.
5.3.3 The graduation lines shall be evenly spaced along the longitudinal axis between the zero graduation line and the line for the total graduated capacity. 5.3.4 When the syringe is held vertically, the ends of all graduation lines of similar length shall be vertically beneath each other.
5.3.5 The lengths of the short graduation lines on each scale shall be approximately half the length of the long lines.
5.4 Numbering of scale
5.4.1 When the syringe is held vertically with the conical tip uppermost and with the scale to the front, the numbers shall appear vertical on the scale and in a position such that they would be bisected by a prolongation of the graduation lines to which they relate.
5.4.2 The numbers shall be close to, but shall not touch, the ends of the graduation lines to which they relate.
5.4.3 Sequence of numbering of scale shall be started from the zero graduation line (the word ?€?zero?€? may be omitted) on the bottom of barrel. Examples of scales and the numbering of graduation lines are shown in Figure 2.
5.11.3 Oxidizable substances 1]. compare extracts of groups of syringes with the same volume and batch of...

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