YY/T 1557-2017Thermoplastic polyurethane (TPU) materials for manufacture of infusion transfusion and injection equipments for medical use (English PDF)

Foreword

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

Introduction

Medical thermoplastic polyurethane has good ductility and flex resistance, high strength, abrasion resistance, good biocompatibility, while polyurethane The physical and mechanical properties and processing properties of the material are good, making it widely used in the medical field, such as cannulas and extension tubes for intravenous needle placement, Infusion of the bucket, dropper, piping and so on.

Polyurethane pellets based on the synthesis process, pellets may be residual diisocyanate monomer. It is also possible during its processing Produce this type of monomer. It is reported in the literature residual monomer and its hydrolyzate has some toxicity. Medical infusion, blood transfusion, Syringes with thermoplastic polyurethane materials

1 Scope

This standard specifies the medical infusion, blood transfusions, injection devices with thermoplastic polyurethane material (TPU) (hereinafter referred to as polyurethane material) Technical requirements and test methods, marking, packaging and storage.

This standard applies only to the components of a single polyurethane material, not suitable for blending polyurethane materials (such as polyurethane/polyvinyl chloride, polyurethane Esters/polyoxymethylenes, etc.) and polyurethane specialty materials to which other components such as developer, colorant, glass fiber and the like are added.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

Rubber, vulcanized or thermoplastic - Determination of tensile stress - strain properties GB/T

GB/T 529-2008 Determination of tear strength of vulcanized rubber or thermoplastic rubber (pants, square and crescent-shaped specimen)

Plastics - Determination of tensile properties - Part 1. General principles

GB/T 2411-2008 Plastics and hard rubbers Determination of indentation hardness (Shore hardness) using a durometer

GB/T 2918-1998 plastic sample conditioning and testing of the standard environment Plastics - Determination of hardness - Part 2. Rockwell hardness GB/T 3398.2-2008 Laboratory use specifications and test methods for analysis GB/T 6682-2008 Compression molding of test specimens of plastic thermoplastics materials GB/T 9352-2008

GB/T 14233.1-2008 medical infusion, transfusion, injection apparatus - Part 1. Chemical analysis methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing Preparation of injection molded test specimens of thermoplastic materials - Part 1. General principles and multipurpose test specimens and lengths Preparation of strip samples Pharmacopoeia of the People's Republic of China (2015 edition 4)

3 Requirements