GB/T 10010-2026Plasticized polyvinyl chloride tubing for medical use (English PDF)

1 Scope

This document specifies the classification, requirements, inspection rules, marking, packaging, transportation, and storage of medical flexible polyvinyl chloride tubing (hereinafter referred to as tubing).

The document describes the corresponding experimental methods.

This document applies to applications using polyvinyl chloride resin as the main raw material in medical-related fields, used for conveying fluid media—gases and liquids.

(e.g., blood, medicine, nutrient solution, excrement, etc.), production, inspection, and... of PVC pipes with a Shore (A) hardness in the range of 40-90.

Sale.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 1040.2-2022 Determination of tensile properties of plastics – Part 2.Test conditions for molded and extruded plastics

GB/T 2035 Plastics Terminology

GB/T 2411 Determination of indentation hardness (Shore hardness) of plastics and hard rubber using a hardness tester

GB/T 4615 Determination of Residual Vinyl Chloride Monomer in Polyvinyl Chloride by Gas Chromatography

GB/T 14233.1-2022 Medical infusion, transfusion and injection equipment test methods - Part 1.Chemical analysis methods

GB/T 16886.1 Biological evaluation of medical devices – Part 1.Evaluation and testing in the risk management process

YY/T 0466.1 Symbols for medical devices used to provide information to manufacturers - Part 1.General requirements

Pharmacopoeia of the People's Republic of China, Part IV

3 Terms and Definitions

The terms and definitions defined in GB/T 2035 apply to this document.

4 Classification

Pipes are classified into three categories based on their hardness.

---Class I. Shore (A) hardness greater than or equal to 40 and less than 63;

---Class II. Shore (A) hardness greater than or equal to 63 and less than 73;

---Class III. Shore (A) hardness greater than or equal to 73 and less than or equal to 90.

5 Requirements