YY/T 1628-2019Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use (English PDF)

Foreword

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

Introduction

Poly(ethylene chloride) (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is superior in processing properties and preserved in blood It has advantages, and the price of polyvinyl chloride plastic for disposable medical devices is relatively low. Therefore, disposable medical batch plasticized with DEHP There is still a vast market for consumables. The national standard GB/T 15593-1995 "soft polyvinyl chloride plastic for blood transfusion (liquid) appliances" can not meet Disposable medical device products and market surveillance requirements, so before the national standards are revised, the industry standards are formulated to meet the requirements of the products. Seek the need for market regulation.

In this standard, the requirements for raw materials have been added. In view of the wide variety of PVC additives in China, the production formulas of various production enterprises are also Not all the same, it is impossible to give all the additive limits in the standard, but the changes in the formulation of the materials are regulated in the standard to prevent Illegal addition of potentially harmful substances or unauthorized alteration of raw material formulations. Medical device supplementary test method "PVC infusion, blood transfusion apparatus Identification and Quantitative Analysis of Fluorescent Substances is applicable to the detection of fluorescent whitening agents in PVC infusion transfusion devices. Industry standard YY/T 0926,

YY/T 0927 gives quantitative analysis and dissolution of di(2-ethylhexyl) phthalate (DEHP) in polyvinyl chloride medical devices. Guide to measurement. Polyvinyl chloride pellets for medical infusion and blood transfusion equipment

1 Scope

This standard specifies the requirements, test methods, marking, packaging and storage of polyvinyl chloride (PVC) pellets for medical blood transfusion and infusion equipment.

This standard applies to PVC resin as the main body, di(2-ethyl)hexyl phthalate (DEHP) as plasticizer and epoxidized soybean oil.

Or PVC granules modified by blending additives such as epoxidized linseed oil.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

Plastics -- Determination of tensile properties of plastics - Part 2. Test conditions for moulding and extruded plastics

GB/T 2411-2008 Plastic and hard rubber using a hardness tester to determine the indentation hardness (Shore hardness)

GB/T 2917.1-2002 Blends and products based on homopolymers and copolymers of vinyl chloride release hydrogen chloride and any of them at high temperatures Determination of his acidic products Congo red method

GB/T 4615-2013 Determination of polyvinyl chloride residual vinyl chloride monomer - Gas chromatography

GB/T 6682 Analytical laboratory water specifications and test methods

GB 14232.1-2004 Human blood and blood components - Plastic containers - Part 1. Traditional blood bags

GB/T 14233.1-2008 Methods of test for infusions, blood trans

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Requirements