YY/T 1557-2017 (YY/T1557-2017, YYT 1557-2017, YYT1557-2017)
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| YY/T 1557-2017 | English | 119 |
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Thermoplastic polyurethane(TPU) materials for manufacture of infusion, transfusion and injection equipments for medical use
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YY/T 1557-2017
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Standards related to: YY/T 1557-2017
| 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 | 6,694 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Lubrizol Management (Shanghai) Co., Ltd., Covestro Polymer (China) Co., Ltd., Shandong Province Medical Device Product Quality Inspection Center | | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | | Proposing organization | China Food and Drug Administration | | 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
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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