YY/T 1557-2017 English PDF

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YY/T 1557-2017: Thermoplastic polyurethane(TPU) materials for manufacture of infusion, transfusion and injection equipments for medical use
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1557-2017	119	Add to Cart	3 days	Thermoplastic polyurethane(TPU) materials for manufacture of infusion, transfusion and injection equipments for medical use	Valid

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Basic data

Standard ID: YY/T 1557-2017 (YY/T1557-2017)
Description (Translated English): Thermoplastic polyurethane(TPU) materials for manufacture of infusion, transfusion and injection equipments for medical use
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.20
Word Count Estimation: 6,651
Date of Issue: 2017-03-28
Date of Implementation: 2018-04-01
Issuing agency(ies): State Food and Drug Administration

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Thermoplastic polyurethane (TPU) materials for manufacture of infusion, transfusion and injection equipments for medical use ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Medical infusion, blood transfusion, Syringes with thermoplastic polyurethane materials Thermoplasticpolyurethane (TPU) materialsformanufactureofinfusion, 2017-03-28 Posted 2018-04-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Medical Devices Standardization Technical Committee (SAC/TC106) centralized. This standard was drafted unit. Lubrizol (Shanghai) Co., Ltd., Covestro polymer (China) Co., Ltd., Shandong Province, medical device production Quality Inspection Center. The main drafters of this standard. White ice, thin Xiaowen, Yan Ge, Lee number.

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 article Pieces. 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

3.1 Identification According to the People's Republic of China Pharmacopoeia.2015 edition of the four 0402 infrared spectrophotometric determination of medical polyurethane infrared spectrum Should be consistent with the map provided by the manufacturer. 3.2 appearance According to the test 4.3, medical polyurethane material for the uniform particles, no foreign impurities. 3.3 Physical properties The physical properties of medical polyurethane materials should be consistent with the provisions of Table 1. ......

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