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".

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.

Nominal capacity: capacity of the syringe as designated by the manufacturer.

Graduated capacity: 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.

Total graduated capacity: 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 in Figure 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.

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. […]