GB/T 15593-2020Plasticized poly(vinyl chloride) compounds for transfusion (infusion) equipment (English PDF)

1 Scope

GB/T 15593-2020 is the Chinese national standard on plasticized poly(vinyl chloride) compounds for transfusion (infusion) equipment, in the field of rubber and plastic industries. The /T suffix marks it as a recommended standard: it is not compulsory by itself, but it becomes binding as soon as a contract, a tender or a customer specification calls it up - which in practice is how most foreign buyers meet it. It was issued on 19 November 2020 by the State Administration for Market Regulation; Standardization Administration of China, and has been in force since 1 October 2021. Classification: ICS 83.080.20, CCS G32. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

This standard specifies the requirements, test methods, markings, packaging, transportation, storage of plasticized poly(vinyl chloride) compounds for transfusion (infusion) equipment. This standard applies to the PVC plastics for disposable transfusion (infusion) bags, transfusion (infusion) catheters, accessories, which are made through blending and modifying the main material of polyvinyl chloride resin, by adding other necessary additives such as bis(2-ethylhexyl) phthalate (DEHP) plasticizer, epoxy soybean oil and/or epoxy linseed oil.

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 1040.2-2006 Plastics - Determination of tensile properties - Part 2: Test conditions for molding and extrusion plastics

GB/T 2411-2008 Plastics and ebonite - Determination of indentation hardness by means of a durometer (shore hardness)

GB/T 2917.1 Determination of compounds and products based on vinyl chloride homopolymers and copolymers to evolve hydrogen chloride and any other acidic products at elevated temperatures - Congo red method

GB/T 4615 Poly (vinyl chloride) - Determination of residual vinyl chloride monomer content - Gas chromatographic method

GB/T 5470-2008 Plastics - Determination of the brittleness temperature by impact

GB/T 9345.5-2010 Plastics - Determination of ash - Part 5: Poly (vinyl chloride)

GB 14232.1-2020 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers

GB/T 14233.1-2008 Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

3 Requirements

3.1 Material requirements It shall control the raw materials used in production. It shall not artificially add the substances, that have been prohibited in the relevant regulations and instructions AND have not been toxicologically evaluated. Any changes in the material formula shall be approved by the user AND subject to related verification.

Note: The recognition that bis(2-ethylhexyl) phthalate (DEHP) plasticizers have reproductive toxicity risks is widely accepted. The application of non-DEHP plasticized PVC plastics has become a trend. Pellets manufacturers and medical device manufacturers should conduct risk assessments, on the safety of materials and devices, based on their end use. For information about non- phthalic plasticizers and non-phthalic PVC plastics, see Appendix A.

3.2 Appearance It is in natural transparent or natural translucent particles, in uniform color, without charred particles, foreign impurities. For special colors, it can be determined, through negotiation between the user and the manufacturer.

4 Inspection method...

Appendix C

(Normative) Test method of water absorption C.1 Test sample There are 10 specimens of 25 mm × 70 mm with straight edges, wherein 5 specimens are the test group, the other 5 specimens are the blank control group. C.2 Test instrument C.2.1 Analytical balance, which has an accuracy of 0.0001 g. C.2.2 Constant temperature water bath, which has an accuracy of 0.5 °C. C.2.3 Drying box, which has an accuracy of 1 °C. C.2.4 Drying tank. C.3 Test procedure C.3.1 Cut 10 pieces of 25 mm × 70 mm specimens, with straight edges, wherein 5 specimens are the test group, the other 5 specimens are the blank control group. C.3.2 Wash the pieces with soapy water, normal water, laboratory grade 2 water one by one. Use clean degreasing gauze and silk cloth to wipe off the surface moisture and fibers. C.3.3 Accurately weigh the total mass of the test group (A) and the blank control group (B), accurate to

0.1 mg. C.3.4 Use spiral stainless steel wire, to separate each specimen of the test group, at an appropriate distance. Immerse the specimen in a constant temperature water tank, which has reached the constant temperature of (50 ± 0.5) °C. Soak it for 2 h ± 20 s. C.3.5 After taking out the specimen from the constant temperature water tank, immediately put it into water at room temperature. Take it out after 5 min. Wipe off the water. Accurately weigh it within 2 min ± 20 s (C), accurate to