YY/T 0573.4-2020Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (English PDF)

Foreword

YY/T 0573 "Sterile hypodermic syringes for single use" consists of the following parts:

- Part 2: Syringes for use with power-driven syringe pumps;

- Part 3: Auto-disable syringes for fixed dose immunization;

- Part 4: Syringes with re-use prevention feature.

This part is part 4 of YY/T 0573.

GB 15810 "Sterile syringes for single use" adopts, through modification, the ISO 7886-1 "Sterile hypodermic syringes for single use - Part 1: Syringes for manual use". Therefore, the standard series of YY/T 0573 "Sterile hypodermic syringes for single use" does not have part 1.

This part was drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY 0573.4-2010 "Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature".

Compared with YY 0573.4-2010, the main technical changes in this part are as follows:

- INTRODUCE the content of 15.4 "Performance after shipment" into 8.3 "Large package" (see 8.3);

- ADD the requirements for easy oxides and ethylene oxide residues, in the chemical requirements (see 6.3, 6.4);

- ADD the requirements for sterility and bacterial endotoxins, in the biological requirements (see 7.2, 7.3);

- MODIFY the requirements of "initial packaging or self-sealing packaging" (see 8.1; Chapter 16 of the 2010 edition);

- ADD the Appendix A "Test methods for capacity tolerance and residual capacity" (see Appendix A);

- ADD the Appendix B "Test method for leakage at the connection of the fixed needle tube and the needle seat, at the piston or seal ring, when the syringe is under positive pressure" (see Appendix B);

- ADD the Appendix C "Test method for leakage, at piston or sealing ring AND separation of piston and core rod, when syringe is pumped under negative pressure" (see Appendix C);

- ADD the Appendix D "Test method for fit between jacket and piston assembly" (see Appendix D);

- ADD F.2 "Test method for residual ethylene oxide" (see Appendix F);

- ADD the Appendix G "Guidelines for design and materials" (see Appendix G);

- DELETE the Appendix C "Environmental aspects" of the original standard (see Appendix C of the 2010 edition).

This part uses the redrafting method to modify and adopt ISO 7886-4:2006 "Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature" The technical differences between this part and ISO 7886-4:2006, as well as the reasons, are as follows:

- Regarding normative references, this part has made adjustments with technical differences, to adapt to China's technical conditions. The adjustments are specifically reflected in Chapter 2 "Normative references"; the specific adjustments are as follows:

- DELETE the ISO 7000;

- DELETE the ASTM D999-01;

- DELETE the ASTM D5276-98;

- USE the GB/T 6682-2008, which modifies and adopts the international standard, to replace ISO 3696:1987;

- USE the GB 15811-2016, which non-equivalently adopts the international standard, to replace ISO 7864:1993 (see 5.6.2);

- USE the GB/T 18457-2015, which modifies and adopts the international standard, to replace ISO 9626 (see 5.6.2);

- USE the GB/T 191-2008, which modifies and adopts the international standard, to replace ISO 780 (see 9.1);

- USE the GB 15810, which modifies and adopts the international standard, to replace ISO 7886-1:1993 (see Chapter 3);

- USE the YY/T 0497, which modifies and adopts the international standard, to replace ISO 8537:1991 (see Chapter 3);

1 Scope

This part of YY/T 0573 specifies the terms and definitions, naming and classification, physical requirements, chemical requirements, biological requirements, packaging, markings, etc. of sterile hypodermic syringes for single use (hereinafter referred to as syringes) with re-use prevention features.

This part applies to sterile hypodermic syringes for single use, which are made of plastic materials, with or without needles, used for aspirating liquids OR for injection immediately after aspirating liquids, designed to prevent re-use. It is suitable for the re-use prevention performance of syringe, which can prevent accidental needle stick injury. This part does not involve the performance of preventing accidental needle stick injury of this type of syringe.

This part does not apply to glass syringes, self-destructive fixed-dose vaccine syringes, syringes with prefilled liquid medicine. This part does not involve the compatibility of the syringe and the injection liquid.

This part does not specify the design requirements for self-destructive features.

Note: When the syringe is used beyond the intended use, which is specified in this part, other standards apply.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard.

GB/T 191-2008 Packaging - Pictorial marking for handling of goods (ISO 780:1997, MOD)

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, the needle seat.

When tested according to Appendix C, there shall be no gas leakage, at the piston or sealing ring; meanwhile the reading of the pressure gauge shall not continue to drop.

5 Physical requirements

6 Chemical requirements

7 Biological requirements

8 Packaging