Annex B (Normative) Test method of discoloration 9
Annex C (Informative) Test method for permanent compression rate of plunger seals 10
Annex D (Normative) Method for preparing test solution 13
Bibliography 14
Foreword
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.
This standard is developed in accordance with the rules given in GB/T 1.1-2009 Directives for standardization - Part 1: Structure and drafting of standards.
This standard replaces YY/T 0243-2003 Plunger of sterile syringes for single use.
The following main technical changes have been made with respect to YY/T 0243-2003:
——The "Annex A (informative) Material guidelines" is added, and the biological evaluation requirements are modified;
——The requirements for ultraviolet absorbance are added;
——The ash requirements are added;
——The test method of discoloration is modified;
——The "Annex C (informative) Test method for permanent compression rate of plungers" is added.
——The amount of leachate in preparation of plunger seal's test solution in Annex D is modified.
Attention is drawn to the possibility that some content of this document may involve patents. 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 Food and Drug Administration.
This standard is under the jurisdiction of National Technical Committee on Medical Syringe (Needle) of Standardization Administration of China.
The previous editions of this standard are as follows:
——YY/T 0243-1996, YY/T 0243-2003.
Plunger seal of syringes for single use
1 Scope
This standard specifies the terms and definitions, classification and marking, requirements, type inspection, packaging, marking, transportation and storage of plunger seals of syringes for single use (hereinafter referred to as plunger seal).
This standard is applicable to plunger seal of syringes for single use. The plunger seal is also applicable to disposable sterile syringes and disposable sterile insulin syringes, but is not applicable to pre-filled syringes with liquid medicine 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 (including any amendments) applies.
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 3512-2001 Rubber, vulcanized or thermoplastic - Accelerated aging and heat resistance tests - Air-oven method
GB/T 7759 Rubber, vulcanized or thermoplastic - Determination of compression set at ambient elevated or low temperatures (GB/T 7759-1996, ISO 815: 1991, EQV)
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 equipments for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1: 2009, IDT)
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (GB/T 16886.5-2003, ISO 10993-5: 1999, IDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (GB/T 16886.12-2005, ISO 10993-12: 2002, IDT)
YY/T 0313 Package, label, transport and storage for medical polymer products
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. See Figure 1 for the terminology for each part of the plunger seal.
1—fiducial line; 2—seal line; 3—trim line
Note: This schematic diagram only illustrates the structure of the plunger seal and is not the only type specified in the standard.
Figure 1 Plunger seal of syringes for single use
3.1
fiducial line
external tangent line at the end of the plunger seal, used to determine the corresponding volume for any scale reading on the syringe
3.2
seal line
external tangent line at the side of the plunger seal, which cooperates with the syringe barrel to achieve sealing
3.3
trim line
external tangent line at the front end of the plunger seal, designed for trimming during the manufacturing process
4 Classification and marking
4.1 Classification
The plunger seals are classified into natural rubber plunger seals and synthetic rubber plunger seals according to manufacturing materials. Note: Guidelines for materials are given in Annex A.
4.2 Marking
The plunger seal is marked according to the matching syringe capacity, such as 0.3 mL, 0.5 mL, 1 mL, 2 mL, 5 mL, 10 mL, 20 mL, 30 mL, 50 mL, 100 mL, etc.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Classification and marking 5 Requirements 6 Type inspection 7 Packaging 8 Marking 9 Transportation and storage Annex A (Informative) Guidance of materials Annex B (Normative) Test method of discoloration Annex C (Informative) Test method for permanent compression rate of plunger seals Annex D (Normative) Method for preparing test solution Bibliography
7.1 初包装 采用双层塑料袋密封包装。 包装的材料不得对内装物产生有害影响。此包装的材料和设计应确保： a) 在从包装中取出时，内装物受污染的风险最小； b) 在正常的搬动、运输和贮存期间，对内装物有充分的保护。 7.2 外包装 一件或更多件初包装，应装入一件外包装中。 在正常搬运、运输和贮存期间，外包装应能充分有效地保护内装物。
8 标志
所有标志符号应符合YY/T 0313的规定。 8.1 初包装标记
初包装上至少应有以下标志： a) 内装物的说明，包括产品名称、型号或规格、活塞材料硬度、活塞材料名称； b) 制造厂或供应商的名称和地址； c) 数量； d) 生产批号或日期； e) 失效日期。 8.2 外包装标记 外包装上至少应有以下标志： a) 内装物的说明，包括产品名称、型号或规格、活塞材料硬度、活塞材料名称； b) 制造厂或供应商的名称和地址； c) 数量； d) 生产批号或日期； e) 失效日期； f) 搬运、贮存和运输的要求。
