組織工程醫(yī)療產(chǎn)品 殼聚糖檢測(cè)

組織工程醫(yī)療產(chǎn)品 殼聚糖檢測(cè)項(xiàng)目報(bào)價(jià)？??解決方案？??檢測(cè)周期？??樣品要求？

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YY/T 0606.3-2007組織工程醫(yī)療產(chǎn)品 第3部分：通用分類(lèi)

YY/T 0606的本部分規(guī)定了組織工程醫(yī)療產(chǎn)品分類(lèi)標(biāo)準(zhǔn)的相關(guān)方面，以保證組織工程醫(yī)療產(chǎn)品對(duì)病人和使用者的安全和有效性。本部分不包括傳統(tǒng)意義上的器官和組織移植以及活細(xì)胞治療。 本部分適用于組織工程產(chǎn)品的分類(lèi)要求，不包括其他標(biāo)準(zhǔn)中包括的特定內(nèi)容。

YY/T 0606.10-2008組織工程醫(yī)療產(chǎn)品.第10部分:修復(fù)或再生關(guān)節(jié)軟骨的植入物體內(nèi)評(píng)價(jià)指南

YY/T 0606的本部分規(guī)定了修復(fù)或再生關(guān)節(jié)軟骨的植入物體內(nèi)評(píng)價(jià)的通則。本部分中的植入物 可由天然或合成生物材料（具有生物相容性，可生物降解），或其復(fù)合物構(gòu)成，可含有細(xì)胞、藥物，或生長(zhǎng)因子、合成多肽、質(zhì)粒或cDNA等生物活性因子。本部分描述了兔、犬、豬、山羊、綿羊等不同種屬的動(dòng)物模型和相應(yīng)的試驗(yàn)程序，以及形態(tài)學(xué)、組織生物化學(xué)和生物力學(xué)分析等結(jié)果測(cè)定和評(píng)價(jià)的方法。

YY/T 0606.12-2007組織工程醫(yī)療產(chǎn)品 第12部分：細(xì)胞、組織、器官的加工處理指南

1．1 YY/T 0606的本部分規(guī)定了用于組織工程醫(yī)療產(chǎn)品(TEMPs)的細(xì)胞、組織和器官的加工處理、檢定、生產(chǎn)以及質(zhì)量保證的要求，包括： a) 細(xì)胞、組織及器官的加工處理（即：設(shè)施、試劑、接收程序、檢查以及貯存；組織培養(yǎng)成分，生物危險(xiǎn)因子以及操作區(qū)域）； b)供體（人源或非人源）及篩查； c)細(xì)胞、組織和器官的檢定及加工。1．2本部分不適用于現(xiàn)行藥品管理法中按照生物制品進(jìn)行管理的產(chǎn)品。

YY/T 0606.13-2008組織工程醫(yī)療產(chǎn)品.第13部分:細(xì)胞自動(dòng)計(jì)數(shù)法

YY/T 0606的本部分所述的原理和方法適用于絕大部分類(lèi)型細(xì)胞的自動(dòng)計(jì)數(shù)，包括黏附生長(zhǎng)細(xì)胞和懸浮生長(zhǎng)細(xì)胞。

YY/T 0606.14-2014組織工程醫(yī)療產(chǎn)品 第14部分:評(píng)價(jià)基質(zhì)及支架免疫反應(yīng)的試驗(yàn)方法:ELISA法

YY/T 0606的本部分規(guī)定了評(píng)價(jià)組織工程醫(yī)療產(chǎn)品基質(zhì)或支架所致哺乳動(dòng)物體液免疫反應(yīng)的試驗(yàn)方法:ELISA法。本部分適用于組織工程醫(yī)療產(chǎn)品基質(zhì)或支架的生物學(xué)評(píng)價(jià)。除本部分所選方法外,可采納其他等效方法。并非所有的材料和應(yīng)用均需要按照本部分進(jìn)行檢測(cè),因此應(yīng)仔細(xì)考慮本部分中方法的適用性。在實(shí)施本部分推薦的試驗(yàn)前,應(yīng)考慮GB/T 16886.1或管理部門(mén)所推薦的試驗(yàn)結(jié)果所提示的信息。

YY/T 0606.20-2014組織工程醫(yī)療產(chǎn)品 第20部分 評(píng)價(jià)基質(zhì)及支架免疫反應(yīng)的試驗(yàn)方法:細(xì)胞遷移試驗(yàn)

YY/T 0606的本部分規(guī)定了評(píng)價(jià)組織工程醫(yī)療產(chǎn)品基質(zhì)或支架所致哺乳動(dòng)物細(xì)胞免疫反應(yīng)的試驗(yàn)方法:細(xì)胞遷移試驗(yàn)。本部分適用于組織工程醫(yī)療產(chǎn)品基質(zhì)或支架的生物學(xué)評(píng)價(jià)。除本部分所選方法外,可采納其他等效方法。并非所有的材料和應(yīng)用均需要按照本部分進(jìn)行檢測(cè),因此應(yīng)仔細(xì)考慮本部分中方法的適用性。在實(shí)施本部分推薦的試驗(yàn)前,應(yīng)考慮GB/T 16886.1或管理部門(mén)所推薦的試驗(yàn)結(jié)果所提示的信息。

YY/T 0953-2020醫(yī)用羧甲基殼聚糖

本標(biāo)準(zhǔn)規(guī)定了醫(yī)用羧甲基殼聚糖原料的要求、試驗(yàn)方法、包裝、運(yùn)輸和貯存等。本標(biāo)準(zhǔn)適用于以殼聚糖或甲殼素為原料，經(jīng)脫乙酰化、羧化、純化而成的用于制造組織工程醫(yī)療器械產(chǎn)品的醫(yī)用羧甲基殼聚糖。

YY/T 1435-2016組織工程醫(yī)療器械產(chǎn)品 水凝膠表征指南

本標(biāo)準(zhǔn)給出了用于表征組織工程醫(yī)療器械產(chǎn)品中水凝膠的生物學(xué)特性、形成動(dòng)力學(xué)、物理與化學(xué)特性及穩(wěn)定性，以及物質(zhì)傳遞等特性的方法指南。

YY/T 1445-2016組織工程醫(yī)療器械產(chǎn)品 術(shù)語(yǔ)

本標(biāo)準(zhǔn)規(guī)定了組織工程醫(yī)療器械產(chǎn)品的基本術(shù)語(yǔ)和定義。

YY/T 1574-2017組織工程醫(yī)療器械產(chǎn)品 海藻酸鹽凝膠固定或微囊化指南

本標(biāo)準(zhǔn)規(guī)定了海藻酸鹽凝膠固定或微囊化評(píng)價(jià)的要求，包括海藻酸鹽凝膠固定或微囊化、微膠囊或微膠珠的性能及其考察、海藻酸鹽凝膠的生物相容性的考察。本標(biāo)準(zhǔn)適用于海藻酸鹽凝膠固定或微囊化的評(píng)價(jià)。

YY/T 1699-2020組織工程醫(yī)療器械產(chǎn)品 殼聚糖

本標(biāo)準(zhǔn)規(guī)定了用于制備組織工程醫(yī)療器械產(chǎn)品的殼聚糖及其鹽的要求、試驗(yàn)方法等。本標(biāo)準(zhǔn)適用于制備組織工程醫(yī)療器械產(chǎn)品的殼聚糖及其鹽。

ASTM F2103-2001(2007)表征和測(cè)試殼聚糖鹽作為原料用于生物醫(yī)學(xué)和組織工程醫(yī)療產(chǎn)品應(yīng)用的標(biāo)準(zhǔn)指南

1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ASTM F2103-2018用于生物醫(yī)學(xué)和組織工程醫(yī)療產(chǎn)品應(yīng)用的殼聚糖鹽作為起始材料的表征和測(cè)試的標(biāo)準(zhǔn)指南

4.1x00a0;This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities. 4.2x00a0;The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application. 4.3x00a0;To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests. 1.1x00a0;This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS). 1.2x00a0;This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts. 1.3x00a0;As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy. 1.4x00a0;Warningx2014;Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPAx2019;s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.5x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6x00a0;This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicabilit......