Download or read book YY T 1571 2017 Translated English of Chinese Standard YY T 1571 2017 YYT1571 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2023-05-26 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the requirements and test methods for sodium hyaluronate used in surgical implants and tissue engineering medical device products. This Standard applies to the preparation of sodium hyaluronate for tissue engineering medical device products and their scaffold materials.

Download or read book YY T 1510 2017 Translated English of Chinese Standard YY T1510 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-08-22 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the general requirements, test methods, inspection rules, marking, instruction for use and packaging of medical plasma virus inactivated device (hereinafter referred to as virus inactivated device). This Standard is applicable to medical plasma virus inactivated device that is matched with virus inactivated device that is stipulated in YY 0765.1.

Download or read book YY T 0595 2020 Translated English of Chinese Standard YYT 0595 2020 YY T0595 2020 YYT0595 2020 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2021-03-20 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: This standard provides guidelines for the application of medical device quality management system requirements in YY/T 0287-2017. This standard applies to organizations of various sizes and types, as well as suppliers or other external parties that provide products and services for them, which involves one or more stages of the life cycle of medical devices.

Download or read book YY T 1524 2017 Translated English of Chinese Standard YYT 1524 2017 YY T1524 2017 YYT1524 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-09-01 with total page 11 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the requirements, test methods, label and use instructions, package, transportation and storage of a-L-fucosidase (AFU) assay kit. This Standard is applicable to reagent (kit) performing quantitative detection by CNPF (2-chloro-4-nitrophenyl-L-fucoylpyranoside) substrate method against the a-L-fucosidase in human serum or plasma; including the reagents used on the manual and semi-automatic, fully automated biochemical analyzers.

Download or read book YY T 0686 2017 Translated English of Chinese Standard YY T 0686 2017 YYT0686 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-12-06 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the classification, materials, requirements, test methods, inspection rules, marking, packaging, transportation and storage of medical forceps.

Download or read book YY T 1122 2017 Translated English of Chinese Standard YY T1122 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-08-10 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the material, hardness, corrosion resistance, surface quality, basic dimensions, usability, test methods and marking for orthopaedics clamps (scissors). This Standard applies to orthopaedics clamps (scissors) which are used to cut or correct bones.

Download or read book YY T 1526 2017 Translated English of Chinese Standard YY T1526 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-08-22 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the requirements, test methods, mark, label and use instructions, package, transportation and storage of detection kit for antigen and antibodies to human immunodeficiency virus (chemiluminescence immuno-assay). This Standard is applicable to the kit perform qualitative detection of human immunodeficiency virus 1 (HIV-1), p24 antigen and (HIV-1 p24) and HIV (including HIV-1 and HIV-2) antibodies in the human serum and/or plasma through the light source (including chemiluminescence analysis, immunofluorescence analysis, time-resolved immunofluorescence analysis) excited by special substance based on the sandwich method; namely, detection kit for antigen and antibodies to human immunodeficiency virus.

Download or read book YY T 1292 4 2017 Translated English of Chinese Standard YYT 1292 4 2017 YY T1292 4 2017 YYT1292 4 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-09-01 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Part of YY/T 1292 specifies methods of testing two-generation reproductive toxicity of medical devices/materials. This Part is applicable to two-generation reproductive and developmental toxicity evaluation of medical devices/materials.

Download or read book YY T 1561 2017 Translated English of Chinese Standard YY T1561 2017 YYT 1561 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-08-21 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard provides a quantitative determination method for remnant α-Gal antigen in biological materials utilizing animal tissues and their derivatives used in the preparation of scaffold materials for tissue engineering medical device products. This Standard applies to the α-Gal antigen determination in various biological materials utilizing animal tissues and their derivatives used for the preparation of scaffold materials for tissue engineering medical device products.

Download or read book YY T 1511 2017 Translated English of Chinese Standard YYT 1511 2017 YY T1511 2017 YYT1511 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-09-14 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies performance requirements and test methods of collagen sponge. This Standard is applicable to sterile collagen sponge. This Standard is not applicable to sponge prepared with genetically engineered collagen and collagen sponge that contains other materials.

Download or read book YY T 1137 2017 Translated English of Chinese Standard YY T1137 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-08-10 with total page 11 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the classification, requirements, test methods, marking, packaging, transport, storage, etc. of orthopaedics saw. This Standard applies to orthopaedics saws for cutting bones and plaster saws for cutting plaster.

Download or read book YY T 1556 2017 Translated English of Chinese Standard YYT 1556 2017 YY T1556 2017 YYT1556 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2019-04-07 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies test methods for particle contamination of intravenous infusion, blood transfusion, injection equipment. This Standard is applicable to particle contamination inspection of intravenous infusion device. For other products, the particle contamination test method can refer to this Standard. This Standard is not applicable to syringe for intramuscular injection with a nominal capacity of 1 mL or less.

Download or read book YY T 1517 2017 Translated English of Chinese Standard YY T1517 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-08-22 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the technical requirements, test methods, label, instruction for use, packaging, transportation and storage of detection kit for IgA antibody to Epsteinbarr viral capsid antigens. This Standard is applicable to detection kit that qualitatively detects IgA antibody to Epstein-Barr viral capsid antigens in human serum/plasma in accordance with the principle of enzyme linked immunosorbent assay, chemiluminescence and timeresolved fluorescence.

Download or read book YY T 1525 2017 Translated English of Chinese Standard YYT 1525 2017 YY T1525 2017 YYT1525 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-09-01 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies the terms and definitions, requirements, test methods, mark, label, use instructions, package, transportation and storage of test kit for methamphetamine (colloidal gold method). This Standard is applicable to the detection kit for the qualitative detection of methamphetamine (MET) in human urine and the combined detection kit containing methamphetamine by the principle of colloidal gold immunochromatography.

Download or read book YY T 1681 2019 Translated English of Chinese Standard YYT 1681 2019 YY T1681 2019 YYT1681 2019 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2020-06-20 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard defines the basic terms and definitions of unique device identification system.

Download or read book YY T 1815 2022 Translated English of Chinese Standard YY T1815 2022 YYT 1815 2022 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-08-21 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document specifies the method that uses threshold of toxicological concern (TTC) to assess the biocompatibility of constituents of a medical device. This document applies to: - Compare with the maximum concentration of identified or unidentified constituents in an extract (see GB/T 16886.18); - Toxicological equivalence studies; - Comparison with the estimated maximum exposure dose for an identified constituent (see GB/T 16886.17).

Download or read book YY T 0618 2017 Translated English of Chinese Standard YY T 0618 2017 YYT0618 2017 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-12-06 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt: This standard specifies basic guidelines for test methods for bacterial endotoxins, which are applicable to the determination of medical devices, components or raw materials. Note: Although the scope of this standard is limited to medical devices, the requirements specified in this standard and the guidelines given may also apply to other medical products. This standard does not apply to the evaluation of pyrogens, other than bacterial endotoxin.