YY/T 0243-2016Plunger seal of syringes for single use (English PDF)

Foreword

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

This standard replaces YY/T 0243-2003 "Plunger of sterile syringes for ingle use".

The main technical changes of this standard and YY/T 0243-2003 are as follows.

- ADD the Appendix A (informative) material guidelines, MODIFY the biological evaluation requirements;

- ADD the UV absorbance requirements;

- ADD the ash requirements;

- MODIFY the yellowing resistance test method;

- ADD the Appendix C (informative) test method for permanent plunger compression;

- MODIFY Appendix D extract preparation method.

1 Scope

This standard specifies the terminology and definition, classification and marking, requirements, type inspection, packaging, marking, transportation and storage of plunger seal of syringes for single use (hereinafter referred to as plunger).

This standard applies to plungers for single-use syringes. The plunger can be used for disposable sterile syringes and disposable sterile insulin syringes, but it is not suitable for syringes with prefilled liquids and syringes matching for liquids.

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) are applicable to this standard.

GB/T 531.1 Rubber vulcanized or thermoplastic - Determination of indentation hardness - Part 1. Durometer method (Shore hardness) (GB/T 531.1-2008, ISO 7619-1:2004 IDT)

GB/T 3512 Rubber, vulcanized or thermoplastic - Accelerated ageing and heat resistance tests

GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696:1987 MOD)

GB/T 7759.1 Rubber, vulcanized or thermoplastic - Determination of compression set - Part 1. At ambient or elevated temperatures (GB 7759.1- 2015, ISO 815-1:2008, IDT)

GB/T 7766-2008 Rubber products - Test methods for chemical analysis

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 5.1.7 The yellowing resistance test is carried out in accordance with the test method of Appendix B. Under the condition of aging at 70 °C for 14 days, the color of the plunger before and after aging shall not change significantly.

5 Requirements

Appendix A (Informative)

Material guide The material used to make the plunger shall be compatible with the sterilization process of a suitable syringe.

The material used to make the plunger shall not have a physical or chemical or other deleterious effect during the routine use of an injection by a suitable syringe.

The material used to make the plunger uses a high quality natural or synthetic rubber polymer. The content of rubber shall not be less than 40%. It can be tested in accordance with clause 4.4 "Rubber polymer content" or clause 5 "Test of rubber polymer" in GB/T 7766-2008. The distinction between natural rubber and non-natural rubber can be determined in accordance with the test method of "Nitrogen content by protein" in clause 4.10.7 of GB/T 7766-2008.

This standard does not limit the progress of technology. If thermoplastic elastomers or other polymer materials are used, manufacturers should make reference to this standard and relevant standards and regulations for evaluation.

The surface of the plunger can optionally use dimethyl silicone oil as a lubricant in accordance with the Chinese National Pharmacopoeia.

The plunger shall not release any substances that have side effects on the human body. When the new product is put into production, materials and production processes have major changes, they shall be evaluated biologically in accordance with GB/T 16886.1. The basic evaluation test is.

a) Pyrogen, it shall be pyrogen free;

b) Cytotoxicity (relative proliferation shall not be greater than grade 2);

c) Sensitization, it shall have no sensitization;

d) Stimulation, it shall have no stimulus response;

e) Hemolysis (hemolysis rate shall be less than 5%);

f) Acute systemic toxicity, there shall be no acute systemic toxicity.