11.120.20 医用材料 标准查询与下载

BS 661210:2018+A1:2022 分级压缩袜、抗栓塞袜和分级支撑袜 规格

What is BS 661210:2018+A1 - Requirements and test methods for hosiery about?    Hosiery is a class of tight-fitting garments with a knit construction, worn on the legs and feet. BS 661210:2018+A1 specifies requirements and test methods for the compression and stiffness of graduated compression hosiery, anti-embolism hosiery and graduated support hosiery.    The test method in BS 661210:2018+A1 might also be suitable for assessing the compression of dual-layer compression kits (e.g. ulcer kits) and other tubular compression devices, e.g. arm sleeves.    Note: There are some garments for which this test method is not suitable, and where the former settings of the test instrument might not accommodate all potential designs, especially some made to measure garments.  ...

Graduated compression hosiery, anti-embolism hosiery and graduated support hosiery. Specification

ASTM F3163-22 皮肤创伤用细胞和/或组织基产品（CTP）的类别和术语的标准指南

1.1 This guide defines terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds. CTPs are TEMPs (tissue-engineered medical products) that are primarily defined by their composition and comprise viable and/or nonviable human or animal cells, viable and/or nonviable tissues, and may include extracellular matrix components. CTPs may additionally include synthetic components. 1.2 This guide also describes categories and terminology for CTPs based on their composition. This systematic categorization is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of these products; the actual biological and clinical functions can depend on characteristics not recognized in the categorization and it should be understood that two products that can be described identically by the categorization should not be presumed to be identical or have the same clinical utility. 1.3 This guide defines CTP-related terminology in the context of skin wounds. However, this guide does not provide a correspondence between the CTP composition and its clinical use(s). More than one product may be suitable for each clinical use, and one product may have more than one clinical use. 1.4 This guide does not purport to address safety concerns with the use of CTPs. It is the responsibility of the user of this standard to establish appropriate safety and health practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the cellular and/or tissue-based products for wounds. 1.5 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 applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds

T/CSBME 042-2021 水凝胶敷料

本文件规定了水凝胶敷料的材料和结构组成、性能要求、试验方法、标志、包装、运输和贮存。 本文件适用于以无菌形式供应的用于创面修复的定形、无定形水凝胶敷料类产品。

Hydrogel dressing

KS P 8002-2021 绷带

Bandage

T/CIRA 22-2021 多功能放射性药物自动化合成模块使用要求

本标准正文包括：范围、规范性引用文件、术语和定义、系统构成、质量管理 、运行管理。

The use requirement of automatic synthesizer for multiple radiopharmaceuticals

T/JSAS 016-2021 肠镜润滑胶浆

4　性能指标 4.1　原材料、塑料瓶 原材料符合《中国药典》的要求，塑料瓶符合药用包装材料要求。 4.2　外观 润滑胶浆为色泽均匀的无色透明或略微白色胶状液体，无可见杂物。 4.3　规格  润滑胶浆装量应与标示规格相符，误差±10%。 4.4　化学性能 酸碱度 pH值应为5.5～7.0。 相对密度 润滑胶浆相对密度为1.00～1.10。 甘油含量 每1g肠镜润滑胶浆甘油的含量不低于150mg。 铁盐 不得超过0.15mg/g。 重金属 以铅计，不得超过0.03mg/g。 黏度 肠镜润滑胶浆的黏度不小于10000mPa?s。 4.5　密封性 按5.4.7检验方法操作，瓶口和瓶盖应配合适宜，不得滑牙。 按5.4.7检验方法操作，肠镜润滑胶浆不得有渗水或冒泡现象。 4.6　微生物指标 肠镜润滑胶浆的细菌菌落总数应≤100cfu/g，真菌菌落总数应≤100cfu/g，不得检出大肠菌群、绿脓杆菌和金黄色葡萄球菌。

Endoscope?lubricant

T/ZZB 2564-2021 阿托伐他汀钙

本文件规定了阿托伐他汀钙的基本要求、技术要求、试验方法、检验规则、标签、包装、运输和贮存、质量承诺等内容。 本文件适用于以 2-[4R,6R)-6-[2-[2-（ 4-氟苯基） - 3-苯基-4-(苯基氨甲酰基） -5-异丙基吡咯-1-基]乙基]-2， 2-二甲基-1, 3-二氧六环-4-基］乙酸叔丁酯（简称 L1）为起始原料，经酸水解、碱水解、成盐等工序制成的阿托伐他汀钙（化学名称、结构、分子式等信息见附录 A）。

Atorvastatin calcium

T/ZZB 2492-2021 包衣肠溶明胶空心胶囊

本文件规定了包衣肠溶明胶空心胶囊（以下简称为“胶囊”）的基本要求、技术要求、试验方法、检验规则、标志、包装、运输和贮存、质量承诺。 本文件适用于采用胶囊用明胶加辅料以三层包衣工艺制成的包衣肠溶明胶空心胶囊。 本文件不适用于结肠肠溶胶囊。

Coated gelatin hollow capsules

YY/T 1803-2021 聚乙烯醇止血海绵

Polyvinyl alcohol hemostatic sponge

YY/T 0617-2021 一次性使用人体末梢血样采集容器

Disposable human peripheral blood sample collection container

YY/T 0314-2021 一次性使用人体静脉血样采集容器

Disposable human venous blood sample collection container

T/CAMDI 061-2021 增材制造金属植入物残留颗粒生物学危害评价标准

本标准为系统性地开展增材制造金属植入物残留颗粒生物学危害研究提供指导，从而达到评价其生物学危害的目的。 本标准适用于以金属粉末为原料，通过以激光或电子束为能量源的粉末床熔融工艺生产的与骨组织接触的植入医疗器械残留颗粒的生物学危害评价。

Evaluation criteria for biological hazards of residual particles in metal implants manufactured by additive manufacturing

T/CAMDI 059-2021 增材制造医用金属粉末重复再利用 控制标准

本标准基于临床需求，对重复再利用的增材制造医用金属粉末的外观质量、流动性、松装密度、化学成分等方面进行规范，从而对金属粉末的重复再利用提供必要的指导。 

Additive manufacturing medical metal powder reuse control standard

T/NJYL 001-2021 理疗肌贴

本文件规定了理疗肌贴的术语和定义、要求、试验方法、检验规则、标志、包装、运输及贮存。 本文件适用于采用弹性束缚原理，预防、治疗运动损伤后软组织肿胀、劳损和损伤等疼痛症状以及颈、肩、腰、椎退行性改变的肌贴产品。

Kinesology tape

T/GDAQI 70-2021 负压引流用聚氨酯海绵

本文件规定了负压引流用聚氨酯海绵的基本要求和检验方法，以及标志、包装、运输贮存。

Polyurethane Sponge for Negative Pressure Wound Therapy

T/ZZB 2070-2021 明胶空心胶囊

本文件规定了明胶空心胶囊（以下简称为“胶囊”）的分类、基本要求、技术要求、试验方法、检验规则、标志、包装、运输与贮存及质量承诺。 本文件适用于由胶囊用明胶加辅料制成的空心硬胶囊。

Vacant gelatin capsules

OENORM EN 13726-2021 伤口敷料的试验方法 吸收性和透湿性、防水性和贴合性方面

Test methods for wound dressings - Aspects of absorbency and moisture vapour transmission, waterproofness and conformability

21/30419932 DC BS EN 13726 伤口敷料的测试方法 吸收性和湿气传输、防水性和舒适性方面

BS EN 13726. Test methods for wound dressings. Aspects of absorbency and moisture vapour transmission, waterproofness and conformability

T/CSBME 032-2021 医用四臂聚乙二醇琥珀酰亚胺戊二酸酯原材料技术要求

本文件规定了医用四臂聚乙二醇琥珀酰亚胺戊二酸酯原材料的质量要求、实验方法、检验规则、包装、运输和储存要求。

Technical requirements for raw materials of medical four-arm polyethylene glycol succinimide glutarate

T/CSG 001-2020 医药包材用低密度聚乙烯专用料

为引导医药包材用低密度聚乙烯树脂原料的规范化、标准化，指导医药包材用低密度聚乙烯树脂产品的规范生产、评价、销售，保证医药包材的安全性，针对国内目前医药包材用低密度聚乙烯树脂标准缺失的现状，制定医药包材领域用的低密度聚乙烯树脂团体标准。 本团体标准的制定，完善了医药包材用低密度聚乙烯树脂产品的标准体系，使国产低密度聚乙烯树脂产品在医药包材领域得以推广应用，填补了医药包材用低密度聚乙烯树脂产品的国内空白，促进医药包材用低密度聚乙烯树脂产品的推广应用。

Low density polyethylene material for manufacture of medical packaging