1 Scope
This standard specifies the nomenclature, physical requirements, chemical requirements, biological requirements, packaging, marking and storage of sterile syringes for single use (hereinafter referred to as "syringes").
This standard is applicable to syringes for manual use for liquid suction or injection immediately after liquid suction.
This standard does not apply to insulin syringes, glass syringes, syringes permanently with needles, syringes with power-driven syringe pumps, self-destruct syringes with fixed dose vaccine, syringes to prevent reuse, syringes pre-loaded with liquid medicine by manufacturers and syringes matched with liquid medicine.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 requirements (YY/T 0466.1-2016; ISO 15223-1: 2012, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
nominal capacity
capacity of the syringe as designated by the manufacturer
Examples: 1 mL, 5 mL and 50 mL.
3.2
graduated capacity
volume of water, at 18 °C to 28 °C, expelled from the syringe when the fiducial line on the plunger stoppers traverses a given scale interval or intervals
3.3
total graduated capacity
capacity of the syringe at the graduation line furthest from the zero graduation line
Note: The total graduated capacity may be equal to or greater than the nominal capacity.
3.4
maximum usable capacity
capacity of the syringe when the plunger stopper is drawn back to its furthest functional position
3.5
fiducial line
leading edge on the plunger stopper that is in contact with and perpendicular to the syringe barrel and aligns with the zero marking on the syringe barrel when the piston is fully inserted
3.6
two-piece syringe
syringe assembly comprises the barrel and piston (3.12), whereas plunger and plunger stopper form one component made of the same material
3.7
three-piece syringe
syringe assembly includes the barrel and piston (3.12), whereas plunger and plunger stopper are two separate components made of different materials
3.8
nozzle cap
sheath intended to physically protect the nozzle prior to use
Foreword i
Introduction v
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Physical requirements
5.1 Appearance
5.2 Tolerance on graduated capacity
5.3 Graduated scale
5.4 Barrel
5.5 Piston
5.6 Nozzle
5.7 Performance
6 Chemical requirements
6.1 Acidity or alkalinity
6.2 Content of extractable metals
6.3 Readily oxidizable substance
6.4 Residual quantity of ethylene oxide
7 Biological requirement
7.1 General
7.2 Sterility
7.3 Bacterial endotoxin
8 Packaging
8.1 Primary packaging
8.2 Medium packaging
9 Marking
9.1 General
9.2 Primary packaging
9.3 Medium packaging
9.4 Large packaging
9.5 Transport wrapping
10 Storage
Annex A (Informative) Structural changes of this Standard with respect to ISO 7886-1: 2017
Annex B (Normative) Test method for capacity tolerance and dead space
Annex C (Normative) Test method for liquid leakage of syringe at plunger stoppers or seal(s) under positive compression
Annex D (Normative) Test method for leakage past piston or seal(s) during aspiration, and for separation of plunger stopper and plunger
Annex E (Normative) Test method for sliding performance
Annex F (Normative) Test method for fitting between syringe barrel and piston
Annex G (Normative) Preparation of extracts and test method
Annex H (Informative) Guidelines for design and materials
Bibliography
1 Scope
This standard specifies the nomenclature, physical requirements, chemical requirements, biological requirements, packaging, marking and storage of sterile syringes for single use (hereinafter referred to as "syringes").
This standard is applicable to syringes for manual use for liquid suction or injection immediately after liquid suction.
This standard does not apply to insulin syringes, glass syringes, syringes permanently with needles, syringes with power-driven syringe pumps, self-destruct syringes with fixed dose vaccine, syringes to prevent reuse, syringes pre-loaded with liquid medicine by manufacturers and syringes matched with liquid medicine.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 requirements (YY/T 0466.1-2016; ISO 15223-1: 2012, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
nominal capacity
capacity of the syringe as designated by the manufacturer
Examples: 1 mL, 5 mL and 50 mL.
3.2
graduated capacity
volume of water, at 18 °C to 28 °C, expelled from the syringe when the fiducial line on the plunger stoppers traverses a given scale interval or intervals
3.3
total graduated capacity
capacity of the syringe at the graduation line furthest from the zero graduation line
Note: The total graduated capacity may be equal to or greater than the nominal capacity.
3.4
maximum usable capacity
capacity of the syringe when the plunger stopper is drawn back to its furthest functional position
3.5
fiducial line
leading edge on the plunger stopper that is in contact with and perpendicular to the syringe barrel and aligns with the zero marking on the syringe barrel when the piston is fully inserted
3.6
two-piece syringe
syringe assembly comprises the barrel and piston (3.12), whereas plunger and plunger stopper form one component made of the same material
3.7
three-piece syringe
syringe assembly includes the barrel and piston (3.12), whereas plunger and plunger stopper are two separate components made of different materials
3.8
nozzle cap
sheath intended to physically protect the nozzle prior to use
Contents of GB 15810-2019
Foreword i
Introduction v
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Physical requirements
5.1 Appearance
5.2 Tolerance on graduated capacity
5.3 Graduated scale
5.4 Barrel
5.5 Piston
5.6 Nozzle
5.7 Performance
6 Chemical requirements
6.1 Acidity or alkalinity
6.2 Content of extractable metals
6.3 Readily oxidizable substance
6.4 Residual quantity of ethylene oxide
7 Biological requirement
7.1 General
7.2 Sterility
7.3 Bacterial endotoxin
8 Packaging
8.1 Primary packaging
8.2 Medium packaging
9 Marking
9.1 General
9.2 Primary packaging
9.3 Medium packaging
9.4 Large packaging
9.5 Transport wrapping
10 Storage
Annex A (Informative) Structural changes of this Standard with respect to ISO 7886-1: 2017
Annex B (Normative) Test method for capacity tolerance and dead space
Annex C (Normative) Test method for liquid leakage of syringe at plunger stoppers or seal(s) under positive compression
Annex D (Normative) Test method for leakage past piston or seal(s) during aspiration, and for separation of plunger stopper and plunger
Annex E (Normative) Test method for sliding performance
Annex F (Normative) Test method for fitting between syringe barrel and piston
Annex G (Normative) Preparation of extracts and test method
Annex H (Informative) Guidelines for design and materials
Bibliography
