GB/T 10010-2009
Plasticized polyvinyl chloride(PVC) tubing for medical uses (English Version)

Standard No.

GB/T 10010-2009

Language

Chinese, Available in English version

Release Date

2009

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 10010-2009

Replace

GB 10010-1988

Scope

This standard specifies the requirements, test methods, inspection rules, signs, packaging, transportation and storage of medical flexible polyvinyl chloride pipes. This standard is applicable to the use of polyvinyl chloride resin as the main raw material, used in medical related fields, used to transport fluid medium gas, liquid (such as blood, medicinal liquid, nutrient liquid, excrement liquid, etc.), Shore (A) hardness in PVC pipes in the range of 40~90 (hereinafter referred to as pipes).

GB/T 10010-2009 Referenced Document

• GB/T 1040.2-2006 Plastics. Determination of tensile properties. Part 2: Test conditions for moulding and extrusion plastics
• GB/T 14233.1-1998 Infusion, transfusion, injection equipment 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*， 2022-04-15 Update
• GB/T 191 Packaging.Pictorial marking for handling of goods
• GB/T 2411 Plastics and ebonite.Determination of indentation hardness by means of a durometer(shore hardness)
• GB/T 2828.1-2003 Sampling procedures for inspection by attributes--Part 1: Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
• GB/T 4615-2008 Poly(vinyl chloride).Determination of residual vinyl chloride monomer content.Gas chromatographic method

GB/T 10010-2009 history

• 2009 GB 10010-2009 Plasticized polyvinyl chloride(PVC) tubing for medical uses
• 1988 GB 10010-1988 Plasticized polyvinyl chloride (PVC) tubing for medical uses

GB/T 10010-2009 Plasticized polyvinyl chloride(PVC) tubing for medical uses has been changed from GB 10010-1988 Plasticized polyvinyl chloride (PVC) tubing for medical uses.