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GB 15810-2019: Sterile syringes for single use
GB 15810-2019
NATIONAL STANDARD OF THE
PEOPLE?€?S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing GB 15810-2001
Sterile syringes for single use
(ISO 7886-1:2017, Sterile hypodermic syringes for single use -
Part 1: Syringes for manual use, MOD)
ISSUED ON: OCTOBER 14, 2019
IMPLEMENTED ON: NOVEMBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 4??
Introduction ... 8??
1 Scope ... 9??
2 Normative references ... 9??
3 Terms and definitions ... 10??
4 Nomenclature ... 11??
5 Physical requirements ... 12??
5.1 Appearance ... 12??
5.2 Tolerance on graduated capacity... 13??
5.3 Graduated scale ... 13??
5.4 Barrel ... 15??
5.5 Piston ... 16??
5.6 Nozzle ... 16??
5.7 Performance ... 16??
6 Chemical requirements ... 17??
6.1 Acidity or alkalinity ... 17??
6.2 Limits for extractable metals ... 17??
6.3 Readily-oxidizable substance ... 18??
6.4 Ethylene oxide residue ... 18??
7 Biological requirements ... 18??
7.1 General ... 18??
7.2 Sterility ... 18??
7.3 Bacterial endotoxin ... 18??
8 Packaging ... 19??
8.1 Primary packaging ... 19??
8.2 Medium packaging ... 19??
9 Marking ... 19??
9.1 General ... 19??
9.2 Primary packaging ... 20??
9.3 Medium packaging ... 20??
9.4 Large packaging ... 20??
9.5 Transport wrapping ... 21??
10 Storage ... 21??
Annex A (Informative) Structural changes of this Standard compared with ISO
7886-1:2017 ... 22??
Annex B (Normative) Methods for determination of capacity tolerance and dead
space ... 23??
Annex C (Normative) Test method for leakage at syringe plunger stopper or
seal under forward compression ... 26??
Annex D (Normative) Test method for leakage past syringe plunger stopper or
seal during aspiration, and for separation of plunger stopper and plunger ... 28??
Annex E (Normative) Test method for the determination of forces required to
operate the piston ... 31??
Annex F (Normative) Test method for fit of plunger stopper/plunger in barrel 35??
Annex G (Normative) Preparation of extracts and test method ... 36??
Annex H (Informative) Guidelines for design and material ... 38??
Bibliography ... 40??
Foreword
The full technical content of this Standard is mandatory.
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces GB 15810-2001 ?€?Sterile hypodermic syringes for single
use?€?. Compared with GB 15810-2001, the main technical changes of this
Standard are as follows:
- Modify the ?€?Scope?€? (see Clause 1; Clause 1 of the 2001 edition);
- ADD the definitions of ?€?two-piece syringe?€?, ?€?three-piece syringe?€?, ?€?dead
space?€?, ?€?piston?€?, ?€?barrel flanges?€?, ?€?needle cap or shield?€?, and ?€?plunger?€? (see
3.6, 3.7, 3.11, 3.12, 3.13, and 3.14);
- Modify Figure 1 and its name (see Figure 1; Figure 1 of the 2001 edition);
- Modify the requirement for lubricant (see 5.1.4; 5.1.4 of the 2001 edition);
- Modify the requirement for ?€?Push-button spacing?€? (see 5.5.1; 5.5.1 of the
2001 edition);
- Delete ?€?Rubber plunger stoppers shall be free of rubber thread, rubber
scraps, foreign impurities, and frost and shall comply with the provisions of
YY/T 0243. Plunger stoppers made of other materials shall meet the
requirements of corresponding standards?€? (5.8.1 of the 2001 edition);
- ADD ?€?Fit of plunger stopper/plunger in barrel?€? (see 5.7.4);
- Delete ?€?The syringe shall be pyrogen-free?€? (see 5.12.2 of the 2001 edition);
- Delete ?€?Hemolysis: no hemolytic reaction in the syringe?€? (see 5.12.3 of the
2001 edition);
- Delete ?€?Acute systemic toxicity: Syringes shall be free of acute systemic
toxicity?€? (see 5.12.4 of the 2001 edition);
- Delete the ?€?Test methods?€? (see Clause 6 of the 2001 edition);
- Modify the requirements for ?€?Primary packaging?€? and add the requirements
for primary packaging materials and needle packaging forms (see 8.1; 7.1
of the 2001 edition);
- ADD ?€?Structural changes of this Standard compared with ISO 7886-1:2017?€?
(see Annex A);
- ADD ?€?Methods for determination of capacity tolerance and dead space?€?
(see Annex B);
- ADD ?€?Test method for leakage at syringe plunger stopper or seal under
forward compression?€? (see Annex C);
- ADD ?€?Test method for leakage past syringe plunger stopper or seal during
aspiration, and for separation of plunger stopper and plunger?€? (see Annex
D);
- Modify ?€?Test method for the determination of forces required to operate the
piston?€? (see Annex E);
- ADD ?€?Test method for fit of plunger stopper/plunger in barrel?€? (see Annex
F);
- ADD ?€?Preparation of extracts and test method?€? (see Annex G);
- Combine ?€?Biological evaluation?€? and ?€?Material guide?€? into ?€?Guidelines for
design and material?€? and modify them (see Annex H; Annex D and Annex
E of the 2001 edition);
- Delete ?€?Hemolysis test?€? (see Annex B of the 2001 edition);
- Delete ?€?Inspection rules?€? (see Annex C of the 2001 edition).
This Standard uses the redraft law to modify and adopt ISO 7886-1:2017
?€?Sterile hypodermic syringes for single use - Part 1: Syringes for manual use?€?.
This Standard, compared with ISO 7886-1:2017, has more adjustments in
structure. Annex A gives the table for comparison of clause-subclause numbers
of this Standard and ISO 7886-1:2017.
The technical differences between this Standard and ISO 7886-1:2017 and
their reasons are as follows:
- As for the normative references, this Standard has adjusted the technical
differences, to adapt to the technical conditions of China. The adjustments
are reflected in Clause 2 ?€?Normative references?€?. The specific adjustments
are as follows:
??? Replace ISO 15223-1:2016 with YY/T 0466.1 identical to the
international standard;
??? Delete ISO 23908;
??? Delete ISO 80369-7;
??? ADD reference to GB/T 1962.1 (see 5.6.1);
??? ADD reference to GB/T 1962.2 (see 5.6.1);
??? ADD reference to GB/T 6682 (see B.1.2.3, B.2.2.2, C.2.4, E.2.4, F.2,
G.1.2.1, G.2);
??? ADD reference to GB/T 14233.1-2018 (see 6.3, G.2);
??? ADD reference to GB/T 14233.2 (see 7.3);
??? ADD reference to YY/T 0466.1 (see 9.1);
- Modify the requirements of ?€?Scope?€? and delete the requirement that
syringes without a needle are intended for use with sterile hypodermic
needles for single use;
- Delete unit packaging, user packaging, self-contained syringe, and multiple
unit pack in ?€?Terms and definitions?€?;
- Modify the requirements for ?€?Appearance?€? and adjust the expression of test
conditions;
- Incorporate design requirements and lubricant requirements into Annex H
(informative) ?€?Guidelines for design and material?€? and modify them;
- ADD requirements for readily-oxidizable substance (see 6.3) and ethylene
oxide residue (see 6.4) in chemical requirements;
- ADD requirements for sterility (see 7.2) and bacterial endotoxin (see 7.3) in
biological requirements;
- Modify the requirements of 8.1 ?€?Primary packaging?€? and add the
requirement that primary packaging shall use breathable packaging
materials and the requirement for needle packaging form;
- ADD ?€?Methods for determination of capacity tolerance and dead space?€?
(see Annex B);
- ADD ?€?Test method for fit of plunger stopper/plunger in barrel?€? (see Annex
F);
- Modify ?€?Preparation of extracts of acidity or alkalinity/limits for extractable
metals/readily-oxidizable substance?€? (see G.1);
- ADD ?€?Test method for ethylene oxide residue?€? (see G.2);
- Delete ?€?Test method for the quantity of silicone?€? (See Annex F of ISO 7886-
Sterile syringes for single use
1 Scope
This Standard specifies the nomenclature, physical requirements, chemical
requirements, biological requirements, packaging, marking, storage, etc. of
sterile syringes for single use (hereinafter referred to as ?€?syringes?€?).
This Standard applies to manual syringes for aspiration of fluids or for
immediate injection after aspirating fluids.
This Standard excludes syringes for use with insulin, syringes made of glass,
syringes with needle permanently, syringes for use with power-driven syringe
pumps, auto-disable fixed-dose vaccine syringes, syringes against reuse,
syringes pre-filled by the manufacturer, and syringes matched with liquid
medicine, etc.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement (GB/T 1962.1-
2015, ISO 594-1:1986, IDT)
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001,
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 Test methods for infusion, transfusion, injection equipment for
medical use - Part 2: Biological test methods
YY/T 0466.1 Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General