GB 15810-2019Sterile syringes for single use (English PDF)

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-

1.2007).

This Standard has made the following editorial changes.

- Modify the standard name;

- ADD Annex A "Structural changes of this Standard compared with ISO

7886-1.2017".

Attention is drawn to the possibility that some of the elements of this document

may be the subject of patent rights. The issuing authority of this document shall

not be held responsible for identifying any or all such patent rights.

This Standard was proposed by and shall be under the jurisdiction of National

Medical Products Administration.

Drafting organizations of this Standard. Shanghai Kindly Enterprise

Development Group Co., Ltd., Shandong Weigao Group Medical Polymer Co.,

Ltd., Jiangxi Hongda Medical Equipment Group Ltd., Chengdu Xinjin Shifeng

Medical Apparatus & Instrument Co., Ltd., Shanghai Testing and Inspection

Institute for Medical Devices.

Main drafters of this Standard. Gao Yicen, Xia Xinrui, Li Jun, Wang Haiyin,

Xiong Rongrong, Tian Xinglong, Ding Biao, Hua Songhe.

The previous editions of the standard replaced by this Standard were released

as follows.

- GB 15810-1987, GB 15810-1995, GB 15810-2001.

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").

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)

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

Capacity of the syringe as designated by the manufacturer.

Volume of water, at 18 °C to 28 °C, expelled from the syringe when the fiducial

line on the piston traverses a given scale interval or intervals.

Capacity of the syringe at the graduation line furthest from the zero graduation line.

4 Nomenclature

The nomenclature for the components of hypodermic syringes is shown inFigure 1.

5 Physical requirements

The tolerances on the graduated capacity shall be as given in Table 1.

The length of the barrel shall be such that the maximum usable capacity of the

syringe is at least 10 % greater than the nominal capacity.

When the fiducial line of the plunger stopper coincides with the zero graduation

line, the push-button spacing L, as shown in Figure 3, shall be at least 8 mm.

It shall meet the requirements of GB/T 1962.1 or GB/T 1962.2.

6 Chemical requirements

When using a potentiometric pH meter and a corresponding general purpose

electrode to measure, the difference between the pH of the extract prepared in

accordance with G.1 in Annex G and the pH of the blank shall be <=1.

Prepare the extract according to G.1 in Annex G. USE a confirmed micro-

analytical method (such as atomic absorption method or inductively coupled

Nominal capacity of

According to G.1 in Annex G, prepare 20 mL of extract. According to method 2

of 5.2.2 in GB/T 14233.1-2008, perform the test. The syringe extract is

compared with an equal volume of blank control of the same batch.

7 Biological requirements

For the syringe, according to the guidelines given in Annex H, suitable materials

are selected for biocompatibility evaluation.

The syringe in each primary packaging shall be sterilized by a suitable method.

The sterilization process shall be confirmed and routinely controlled, to ensure

that the probability of bacteria survival on the product is less than 10-6.

Validation of the sterilization process shall be documented.

8 Packaging

The syringe, together with the needle if supplied, shall be sealed in a primary

packaging.

A number of primary packaging shall be packed in a medium packaging.

During normal handling, transit, and storage, the medium packaging shall be

able to fully and effectively protect the contents.

9 Marking

All marking symbols shall meet the requirements of YY/T 0466.1.

The primary packaging shall be at least marked with the following information.

The medium packaging shall be at least marked with the following information.

If the medium packaging is packed in a large packaging, the large packaging

shall be at least marked with the following information.

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