Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All technical contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 15810-2001 Sterile hypodermic syringes for single use. The following main technical changes have been made with respect to GB 15810-2001 (the previous edition):
——The clause “Scope” is modified (see Clause 1; Clause 1 of Edition 2001);
——The definitions of "two-piece syringe", "three-piece syringe", "dead space", "piston", "barrel flanges", "needle cap or shield" and "plunger" are added (see 3.6, 3.7, 3.11, 3.12, 3.13 and 3.14);
——The Figure 1 and its name are modified (see Figure 1; Figure 1 of Edition 2001);
——The requirements for lubricating oil are modified (see 5.1.4; 5.1.4 of Edition 2001);
——The requirements for “spacing of push-button” is modified (see 5.5.1; 5.5.1 of Edition 2001);
——The requirements "rubber plunger stoppers shall be free of rubber threads, rubber crumbs, foreign impurities and frost spray, and shall conform to those specified in YY/T 0243, and plunger stoppers made of other materials shall conform to those specified in corresponding standards" are deleted (5.8.1 of Edition 2001);
——The “fit of piston in barrel” is added (see 5.7.4);
——The requirement “syringes shall be pyrogen free" is deleted (see 5.12.2 of Edition 2001);
——The requirement “hemolysis: syringe has no hemolysis reaction" is deleted (see 5.12.3 of Edition 2001);
——The requirement "acute systemic toxicity: syringe shall have no acute systemic toxicity" is deleted (see 5.12.4 of Edition 2001);
——“Test method” is deleted (see Clause 6 of Edition 2001);
——The requirements for "primary packaging" are modified, and the requirements for primary packaging materials and needle packaging forms are added (see 8.1; 7.1 of Edition 2001);
——The “Structural changes of this standard with respect to ISO 7886-1: 2017” is added (see Annex A);
——The “Test method for capacity tolerance and residual capacity” is added (see Annex B);
——The “Test method for liquid leakage of syringe at piston or seal(s) under positive compression” is added (see Annex C);
——The “Test method for leakage past piston or seal(s) during aspiration, and for separation of piston and plunger” is added (see Annex D);
——The “Test method for sliding performance” is modified (see Annex E);
——The “Test method for fitting between syringe barrel and piston” is added (see Annex F);
——The “Preparation of extracts and test method” is added (see Annex G);
——The “biological evaluation” and “material guide” are combined into “Guidelines for design and materials”, which is modified (see Annex H; Annexes D and E of Edition 2001);
——The “hemolysis test” is deleted (see Annex B of Edition 2001);
——The “inspection rules” is deleted (see Annex C of Edition 2001);
This standard is revised by redrafting ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
This standard is changed largely from ISO 7886-1: 2017 in structure; the comparison table for clause numbers in this standard and those in ISO 7886-1：2017 are listed in Annex A.
The technical differences with respect to ISO 7886-1: 2017 and the reasons are as follows:
——The adjustments of technical deviations are made for the normative references in this standard so as to adapt to the technical conditions of China. The specific adjustment is reflected in Clause 2 "Normative reference", with the specific adjustments as follows:
YY/T 0466.1 identical to the international standard is used to replace ISO 15223-1: 2016;
ISO 23908 is deleted;
ISO 80369-7 is deleted;
GB/T 1962.1 is added for reference (see 5.6.1);
GB/T 1962.2 is added for reference (see 5.6.1);
GB/T 6682 is added for reference (see B.1.2.3, B.2.2.2, C.2.4, E.2.4, F.2, G.1.2.1 and G.2);
GB/T 14233.1-2018 is added for reference (see 6.3 and G.2);
GB/T 14233.2 is added for reference (see 7.3);
YY/T 0466.1 is added for reference (see 9.1);
——The requirement of "Scope" is modified, deleting the requirement that syringes without needles be used together with sterile injection needles for single use.
——The unit packaging, user packaging, self-contained syringe units and multiple unit pack in "Terms and definitions" are deleted;
——The requirements for "appearance" are modified, and the expression of test conditions is adjusted;
——The design requirements and lubricant requirements are incorporated into Annex H (informative) "Guidelines for design and materials" and modified;
——The requirements for readily oxidizable substances (see 6.3) and residual ethylene oxide (see 6.4) in chemical requirements are added;
——The requirements for sterility (see 7.2) and bacterial endotoxin (see 7.3) in biological requirements are added;
——The requirements of 8.1 “primary packaging" are modified, and the requirements that air-permeable packaging materials and needle packaging forms be used for primary packaging are added.
——The “Test method for capacity tolerance and residual capacity” is added (see Annex B);
——The “Test method for fitting between syringe barrel and piston” is added (see Annex F);
——The “pH/extractable metal content/preparation of extract of easily oxidized substances” is modified (see G.1);
——The “Test method for ethylene oxide residue” is added (see G.2);
——The “Test method for the quantity of silicone” is deleted (see Annex F of ISO 7886-1: 2007).
The following editorial changes have been made in this standard:
——the standard is renamed;
——The Annex A “Structural changes of this standard with respect to ISO 7886-1: 2017” is added.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by China State Food and Drug Administration.
The previous editions of this standard are as follows:
——GB 15810-1987, GB 15810-1995 and GB 15810-2001.
Introduction
As a single device, sterile syringes for single use needs to be combined with sterile injection needle for single use for clinical application.
This standard encourages the manufacturers to treat the syringe together with the supporting injection needle as sales units, the structures and terms related to injection needles have therefore been added into the "syringe illustration".
Considering that syringes without injection needles shall not be restricted, syringes without injection needles specified in this standard shall be used in conjunction with the sterile injection needles for single use meeting those specified in GB 15811.
If the syringe itself is equipped with an injection needle, the chemical and biological properties shall be tested with the extract prepared with the injection needle mounted on the syringe.
ISO 594-1: 1986 corresponding to GB/T 1962.1-2015 and ISO 594-2: 1998 corresponding to GB/T 1962.2-2001 have been replaced by ISO 80369-7: 2006, and the corresponding professional standard converted is YY/T 0916.7 (under approval).
Sterile syringes for single use
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
3.9
plunger stoppers
seal assembly between the barrel and the plunger
3.10
plunger
device component which advances the plunger stopper (3.9) to deliver the medicinal product
3.11
dead space
residual volume of fluid left in syringe when the plunger stopper (3.9) is fully depressed
3.12
piston
assembled component of plunger (3.10) and plunger stopper (3.9)
3.13
barrel flanges
ergonomic and easy-to-hold raised part on the barrel
3.14
needle cap or shield
sheath intended to physically protect the needle prior to use
4 Nomenclature
The nomenclature for the components of the syringes is shown in Figure 1.
Keys:
1——needle cap or shield (if used); 10——plunger cap;
2——nozzle cap; 11——barrel flange;
3——nozzle lumen; 12——fiducial line;
4——nozzle; 13——nominal capacity line;
5——barrel; 14——graduation lines;
6——plunger stopper; 15——zero line;
7——seals; 16——needle tube;
8——plunger; 17——hub;
9——push-button;
Note: This figure is only used to illustrate the structure of a syringe, which is not the only type required by this standard.
Figure 1 Schematic representation of syringe
5 Physical requirements
5.1 Appearance
5.1.1 When observed with naked eye of normal vision or vision corrected to normal acuity under the illumination of 300 lx~700 lx, the surface of the syringe contacting with the injection liquid during normal use shall be clean and free of particles or foreign matters.
5.1.2 The syringes shall be free of raw edges, burrs, plastic flow and defects.
5.1.3 The syringe barrel shall have sufficient clarity to enable the fiducial line to be read without difficulty.
5.1.4 When the plunger stopper is fully depressed to the bottom of the barrel, lubricant applied shall not enter the nozzle lumen.
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:
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
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All technical contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 15810-2001 Sterile hypodermic syringes for single use. The following main technical changes have been made with respect to GB 15810-2001 (the previous edition):
——The clause “Scope” is modified (see Clause 1; Clause 1 of Edition 2001);
——The definitions of "two-piece syringe", "three-piece syringe", "dead space", "piston", "barrel flanges", "needle cap or shield" and "plunger" are added (see 3.6, 3.7, 3.11, 3.12, 3.13 and 3.14);
——The Figure 1 and its name are modified (see Figure 1; Figure 1 of Edition 2001);
——The requirements for lubricating oil are modified (see 5.1.4; 5.1.4 of Edition 2001);
——The requirements for “spacing of push-button” is modified (see 5.5.1; 5.5.1 of Edition 2001);
——The requirements "rubber plunger stoppers shall be free of rubber threads, rubber crumbs, foreign impurities and frost spray, and shall conform to those specified in YY/T 0243, and plunger stoppers made of other materials shall conform to those specified in corresponding standards" are deleted (5.8.1 of Edition 2001);
——The “fit of piston in barrel” is added (see 5.7.4);
——The requirement “syringes shall be pyrogen free" is deleted (see 5.12.2 of Edition 2001);
——The requirement “hemolysis: syringe has no hemolysis reaction" is deleted (see 5.12.3 of Edition 2001);
——The requirement "acute systemic toxicity: syringe shall have no acute systemic toxicity" is deleted (see 5.12.4 of Edition 2001);
——“Test method” is deleted (see Clause 6 of Edition 2001);
——The requirements for "primary packaging" are modified, and the requirements for primary packaging materials and needle packaging forms are added (see 8.1; 7.1 of Edition 2001);
——The “Structural changes of this standard with respect to ISO 7886-1: 2017” is added (see Annex A);
——The “Test method for capacity tolerance and residual capacity” is added (see Annex B);
——The “Test method for liquid leakage of syringe at piston or seal(s) under positive compression” is added (see Annex C);
——The “Test method for leakage past piston or seal(s) during aspiration, and for separation of piston and plunger” is added (see Annex D);
——The “Test method for sliding performance” is modified (see Annex E);
——The “Test method for fitting between syringe barrel and piston” is added (see Annex F);
——The “Preparation of extracts and test method” is added (see Annex G);
——The “biological evaluation” and “material guide” are combined into “Guidelines for design and materials”, which is modified (see Annex H; Annexes D and E of Edition 2001);
——The “hemolysis test” is deleted (see Annex B of Edition 2001);
——The “inspection rules” is deleted (see Annex C of Edition 2001);
This standard is revised by redrafting ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
This standard is changed largely from ISO 7886-1: 2017 in structure; the comparison table for clause numbers in this standard and those in ISO 7886-1：2017 are listed in Annex A.
The technical differences with respect to ISO 7886-1: 2017 and the reasons are as follows:
——The adjustments of technical deviations are made for the normative references in this standard so as to adapt to the technical conditions of China. The specific adjustment is reflected in Clause 2 "Normative reference", with the specific adjustments as follows:
YY/T 0466.1 identical to the international standard is used to replace ISO 15223-1: 2016;
ISO 23908 is deleted;
ISO 80369-7 is deleted;
GB/T 1962.1 is added for reference (see 5.6.1);
GB/T 1962.2 is added for reference (see 5.6.1);
GB/T 6682 is added for reference (see B.1.2.3, B.2.2.2, C.2.4, E.2.4, F.2, G.1.2.1 and G.2);
GB/T 14233.1-2018 is added for reference (see 6.3 and G.2);
GB/T 14233.2 is added for reference (see 7.3);
YY/T 0466.1 is added for reference (see 9.1);
——The requirement of "Scope" is modified, deleting the requirement that syringes without needles be used together with sterile injection needles for single use.
——The unit packaging, user packaging, self-contained syringe units and multiple unit pack in "Terms and definitions" are deleted;
——The requirements for "appearance" are modified, and the expression of test conditions is adjusted;
——The design requirements and lubricant requirements are incorporated into Annex H (informative) "Guidelines for design and materials" and modified;
——The requirements for readily oxidizable substances (see 6.3) and residual ethylene oxide (see 6.4) in chemical requirements are added;
——The requirements for sterility (see 7.2) and bacterial endotoxin (see 7.3) in biological requirements are added;
——The requirements of 8.1 “primary packaging" are modified, and the requirements that air-permeable packaging materials and needle packaging forms be used for primary packaging are added.
——The “Test method for capacity tolerance and residual capacity” is added (see Annex B);
——The “Test method for fitting between syringe barrel and piston” is added (see Annex F);
——The “pH/extractable metal content/preparation of extract of easily oxidized substances” is modified (see G.1);
——The “Test method for ethylene oxide residue” is added (see G.2);
——The “Test method for the quantity of silicone” is deleted (see Annex F of ISO 7886-1: 2007).
The following editorial changes have been made in this standard:
——the standard is renamed;
——The Annex A “Structural changes of this standard with respect to ISO 7886-1: 2017” is added.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by China State Food and Drug Administration.
The previous editions of this standard are as follows:
——GB 15810-1987, GB 15810-1995 and GB 15810-2001.
Introduction
As a single device, sterile syringes for single use needs to be combined with sterile injection needle for single use for clinical application.
This standard encourages the manufacturers to treat the syringe together with the supporting injection needle as sales units, the structures and terms related to injection needles have therefore been added into the "syringe illustration".
Considering that syringes without injection needles shall not be restricted, syringes without injection needles specified in this standard shall be used in conjunction with the sterile injection needles for single use meeting those specified in GB 15811.
If the syringe itself is equipped with an injection needle, the chemical and biological properties shall be tested with the extract prepared with the injection needle mounted on the syringe.
ISO 594-1: 1986 corresponding to GB/T 1962.1-2015 and ISO 594-2: 1998 corresponding to GB/T 1962.2-2001 have been replaced by ISO 80369-7: 2006, and the corresponding professional standard converted is YY/T 0916.7 (under approval).
Sterile syringes for single use
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
3.9
plunger stoppers
seal assembly between the barrel and the plunger
3.10
plunger
device component which advances the plunger stopper (3.9) to deliver the medicinal product
3.11
dead space
residual volume of fluid left in syringe when the plunger stopper (3.9) is fully depressed
3.12
piston
assembled component of plunger (3.10) and plunger stopper (3.9)
3.13
barrel flanges
ergonomic and easy-to-hold raised part on the barrel
3.14
needle cap or shield
sheath intended to physically protect the needle prior to use
4 Nomenclature
The nomenclature for the components of the syringes is shown in Figure 1.
Keys:
1——needle cap or shield (if used); 10——plunger cap;
2——nozzle cap; 11——barrel flange;
3——nozzle lumen; 12——fiducial line;
4——nozzle; 13——nominal capacity line;
5——barrel; 14——graduation lines;
6——plunger stopper; 15——zero line;
7——seals; 16——needle tube;
8——plunger; 17——hub;
9——push-button;
Note: This figure is only used to illustrate the structure of a syringe, which is not the only type required by this standard.
Figure 1 Schematic representation of syringe
5 Physical requirements
5.1 Appearance
5.1.1 When observed with naked eye of normal vision or vision corrected to normal acuity under the illumination of 300 lx~700 lx, the surface of the syringe contacting with the injection liquid during normal use shall be clean and free of particles or foreign matters.
5.1.2 The syringes shall be free of raw edges, burrs, plastic flow and defects.
5.1.3 The syringe barrel shall have sufficient clarity to enable the fiducial line to be read without difficulty.
5.1.4 When the plunger stopper is fully depressed to the bottom of the barrel, lubricant applied shall not enter the nozzle lumen.
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:
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
