11.140 医院设备 标准查询与下载

GSO ASTM F2100:2022 医用口罩所用材料性能标准规范

This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.

Standard Specification for Performance of Materials Used in Medical Face Masks

GSO ASTM D6977:2022 医疗用聚氯丁二烯检查手套的标准规范

This specification covers certain requirements for polychloroprene rubber gloves intended for use in medical examinations and diagnostic and therapeutic procedures. Gloves shall be manufactured from any polychloroprene rubber compound, with the inside and outside surfaces of the examination gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength and ultimate elongation (both before and after accelerated aging of gloves), powder-free residue, and powder amount shall be performed to assess the conformance of the gloves with the requirements specified.

Standard Specification for Polychloroprene Examination Gloves for Medical Application

GSO ASTM F2101:2022 使用金黄色葡萄球菌生物气溶胶评估医用口罩材料的细菌过滤效率（BFE）的标准测试方法

1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. 1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %. 1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications. 1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material does not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.

Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

T/CSBM 0028-2022 外科植入物用磷酸四钙

1  技术要求 1.1  外观 白色固体粉末，无肉眼可见异物及结块，粉末均匀。 1.2  相组成与含量 1.2.1  根据定量 X 射线衍射分析，TTCP晶体结构的 X 射线衍射谱应符合 ICDD的 PDF粉末衍射卡No.25-1137或No.70-1379。无明显的其它磷酸钙和结晶相物质峰，也无明显的非晶物质表现。 1.2.2  TTCP的结晶相含量不低于95%。CaO含量应不大于1%。 1.3  钙、磷原子比 钙和磷的元素分析应该期望与TTCP[Ca3（PO4）2O]理论的化学计量比相一致，钙（Ca）、磷（P）原子比为2.0±0.05。 1.4  微量元素含量 1.4.1  砷、镉、汞、铅 微量元素的含量应符合表1要求。 表1  微量元素含量 微量元素， 含量 砷（As） ≤3mg/kg 镉（Cd） ≤5mg/kg 汞（Hg） ≤5mg/kg 铅（Pb） ≤30mg/kg 1.4.2  重金属元素总量 1.4.2.1  重金属元素总量（以Pb计）的最大允许量为30mg/kg。 1.4.2.2 对未以铅计的金属或氧化物，其含量大于或等于0.1%时，建议备注列出，并附于包装中。 1.5  水化物抗压强度 TTCP与水接触发生水化反应而形成的水化产物具有一定的强度，应根据其预期用途检测水化物的抗压强度。 1.6 生物活性 TTCP应根据体外沉积羟基磷灰石的测试结果进行生物活性评价。 1.7  生物相容性 α-TCP应根据外科植入物预期用途进行生物相容性评价。 2  试验方法 2.1  外观 目测法，将样品置于白色器皿中，在光线明亮处，用正常视力或矫正视力进行观察。 2.2  相组成与含量 2.2.1  测试器具 测试器具如下∶ e） X射线衍射分析仪； f）箱式电阻炉或高温烧结炉； g）玛瑙研钵； h）铂金或刚玉坩埚。 2.2.2 定标曲线建立 2.2.2.1  HA/TTCP定标曲线绘制 2.2.2.1.1  将TTCP纯粉体置于铂金或刚玉坩埚放入箱式电阻炉中，以每分钟5℃的升温速率加热至1400℃，保温2h后，在空气中冷却至室温，用玛瑙研钵研细；同样将HA纯粉体以每分钟5℃的升温速率加热至1050℃，保温2h后，随炉冷却至室温，用玛瑙研钵研细。 2.2.2.1.2 用 X 射线衍射仪测定以上两种煅烧粉末的衍射谱（CuKα靶、石墨单色器），扫描速度0.2°/min，2θ分辨率大于0.02°，扫描范围2θ∶10°~50°，所得X射线谱图应分别符合ICDD的PDF 粉末衍射卡No.25-1137或No.70-1379（TTCP）和No.09-0432或No.72-1243（HA），不能有其它杂相峰和明显的非晶相显示。 2.2.2.1.3 准确称取上述煅烧粉体，按TTCP质量百分含量分别为0%、10%、30%、50%、70%、90%和100%配制一系列的HA与TTCP的混合标样，分别置于玛瑙研钵中小心研磨混匀。 2.2.2.1.4 按扫描速度0.2°/min，扫描范围2θ∶28°~32.5°获得各混合标样的X射线衍射谱图，分析计算出TTCP的（040）衍射峰（2θ=29.8°）的积分面积ITTCP和HA的（211）衍射峰（20=31.8°）的积分面积IHA，按（1）式分别计算各混合标样中TTCP的相对衍射峰强度ρ。 ρ=Iα-TCP/（Iα-TCP+Iβ-TCP）……………(1) 2.2.2.1.5 混合标样的X射线分析平行测定3次，分别计算获得ρ1、ρ2、ρ3，取算术平均值。基于线性回归法，以TTCP质量百分含量X对相对衍射峰强度ρ作HA/TTCP混合标样的X-ρ定标曲线图，见图1。图1  X-ρ定标曲线 2.2.2.2  CaO/TTCP定标曲线绘制 2.2.2.2.1  将TTCP纯粉体置于铂金或刚玉坩埚放入箱式电阻炉中，以每分钟5℃的升温速率加热至1400℃，保温2h后，在空气中冷却至室温，用玛瑙研钵研细同样将氧化钙（CaO）纯粉体以每分钟5℃的升温速率加热至900℃，保温2h后，随炉冷却至室温，用玛瑙研钵研细。 2.2.2.2.2 用X射线衍射仪分别测定以上两种煅烧粉末的衍射谱CuKα靶、石墨单色器），扫描速度0.2°/min，2θ分辨率大于0.02°，扫描范围2θ∶10°~50°，所得X射线谱图应分别符合国际衍射中心粉末衍射数据库（ICDD）的PDF粉末衍射卡No.25-1137或No.70-1379（TTCP）和No.4-077 或No.82-1690（Ca0），无明显的其它结晶相物质峰和明显的非晶相显示。 2.2.2.2.3 准确称取上述煅烧粉体，按TTCP质量百分含量分别为0%、10%、30%、50%、70%和100%配制一系列Ca0与TTCP的混合标样，分别置于玛瑙研钵中小心研磨混匀。 2.2.2.2.4  按扫描速度0.2°/min，扫描范围2θ∶28°~38°获得各混合标样的X射线衍射谱图，分析计算出TTCP的（040）衍射峰（2θ=29.8°）的积分面积ITTCP和和Ca0的（200）衍射峰（2θ=37.3°）的积分面积ICaO，按（2）式分别计算各混合标样中TTCP的相对衍射峰强度ρ。 ρ=ITTCP/（ITTCP+ICaO）……………(2) 2.2.2.2.5 混合标样的X射线分析平行测定3次，分别计算获得ρ1、ρ2、ρ3，取算术平均值。基于线性回归法，以TTCP质量百分含量X对相对衍射峰强度ρ作CaO/TTCP混合标样的X-ρ定标曲线图，见图2所示。图1  X-ρ定标曲线 2.2.3  测定程序 2.2.3.1  取6g样品用玛瑙研钵研细，按上述方法测定样品的XRD谱图，谱图中主相的衍射峰应符合ICDD的PDF粉末衍射卡No.25-1137或70-1379（TTCP）。杂质相除HA、Ca0外，不能有明显的其他杂相峰和非晶相存在。 2.2.3.2 样品分三次检测，样品中TTCP含量测试∶按扫描速度0.2°/min，2θ分辨率大于0.02°，扫描范围2θ∶28°~38°获得样品的X射线衍射谱图。使用X射线衍射仪的操作软件去除干扰背景，给出TTCP的（040）衍射峰（20=29.8°）的积分面积ITTCP，HA和（211）衍射峰（2θ=31.8°）的积分面积IHA和Ca0的（200）衍射峰（2θ=37.3°）的积分面积ICaO，分别计算ρ1、ρ2、ρ3，取算术平均值，并代入X-ρ定标曲线中得出TTCP的质量百分含量X，最后计算结果以TTCP含量不小于95%，Ca0含量应不大于1%，且X射线衍射谱图中无明显的其它结晶相物质峰和明显的非晶相显示为合格。 2.3 钙、磷原子比 按照GB/T 1871.1测定磷含量，按照GB/T 1871.4测定钙含量，并据此计算钙（Ca）、磷（P）原子比。 2.4 微量元素含量 2.4.1  砷、镉、汞、铅 按照《中华人民共和国药典》（2020年版 四部）通则中0411的电感耦合等离子体发射原子光谱法进行测定。 2.4.2  重金属元素总量 按照《中华人民共和国药典》（2020年版 四部）通则中0821的重金属检查法进行测定。 2.5  水化物抗压强度 2.5.1  测试器具 测试器具如下： a)恒温恒湿箱； b)由不锈钢制成的模具、端板、脱模杆和C型夹或能将模具和端板夹在一起的其它装置，或能制成长度为（12.0±0.1）mm，直径为（6.0±0.1）mm的圆柱体试样的其它装置； c)240目金刚砂纸； d)一块平板； e)脱模剂； f)用于混合水化物的容器； g)能施加并测量至少4kN压力的试验机，有记录负载与十字头位移关系的装置。 2.5.2  试验条件 试验开始前，混合容器及实验设备在（37±1）℃下至少保持2h，试验在（37±1）℃下进行。 2.5.3  试验步骤 2.5.3.1  如需要，模具内表面及两块端板向内表面可涂抹少许脱模剂。 2.5.3.2  将模具置于一块端板上。 2.5.3.3  首先把所需量的去离子水倒入混合容器中，再把已称量的TTCP粉末倒入容器中，并迅速用玻璃棒充分搅拌混合均匀成面团状水化物。 2.5.3.4  在1min内，将面团状水化物填入模具各孔，稍有过量，然后将第二块端板放在模具上方。 2.5.3.5  将端板与模具用C型夹压在一起，约2h后，移开夹具及端板。 2.5.3.6  将模具的两个端面贴在下衬金刚砂纸的平板上来回打磨，以磨平模具内水化物各个圆柱体的两个端面。用脱模杆将水化物圆柱体从模具中脱出。最终获得至少5个长度为（12.0±0.1）mm，直径为（6.0±0.1）mm的圆柱体试样。 2.5.3.7  试样在温度为（37±1）℃、相对湿度为（100%）的环境中养护24h。然后进行抗压强度测定。 2.5.3.8  测量每个试样的平均直径，取垂直于圆柱体试样中心轴的至少两个截面的测量值，将试样放在试验机样品台上。开动试验机在0.05 mm/min~2.0mm/min的范围内用恒定的十字头速率作变形对负载的曲线。当试样断裂时停机。 2.5.3.9 对每个试样重复2.5.3.8步骤。 2.5.4 结果的计算和表达 对每个试样，记录试样断裂前所施加的最大负载，这个力F（N）用以平方毫米表示的试样横截面积A去除，所得到的商即为水化物抗压强度P。如式（3），以兆帕（MPa）为单位，最后计算五个试样的平均抗压强度和标准偏差。 P=F/A…………………………（3) 2.6 生物活性 按照本文件附录A规定的体外沉积羟基磷灰石的测试方法进行评价。 2.7 生物相容性 根据TTCP的预期用途，按照GB/T 16886.1的要求进行生物学评价。 3  标志、包装、运输和贮存 3.1 标志产品的包装物上应有生产厂商的名称、产品名称、地址、电话、商标、型号、批号、净重、生产日期等标志。 3.2  包装 3.2.1  产品应该包装在密闭、防潮的容器中。容器材料应无毒，不污染和影响产品的性能，包装容器应具有正常搬运或贮存期间不损坏，不破裂的性能。 3.2.2  包装上标志齐全，外包装上应注明符合GB/T 191规定的防潮、防震、远离有害物质等字样或标志。 3.2.3  每个包装应附检验合格证和使用说明书，使用说明书应按照国家有关规定进行编写，至少包括以下内容： a） 产品的用途； b） 产品的性能； c） 注意事项。 3.3  运输和贮存 本产品无毒、无腐蚀、不燃烧、无爆炸性能，运输时要求避免受潮、合理装卸及小心轻放。产品应贮存于清洁、干燥、无有害物质的室内。 4  质量保证要求 制造商应有相应的质量保证体系，如符合YY/T 0287的要求。

Tetracalcium phosphate for surgical implantation

T/ZJHIA 02.2-2022 电子健康档案数据传输规范 第2部分：基本档案数据集

根据浙江省内全民健康信息互通共享和实施浙江省数字化改革开展电子健康档案共享等有关要求，通过建立电子健康档案数据传输规范，建立全人全程的电子健康档案数据中心，促进健康档案的共享调阅和便民惠民服务的开展。 依据《浙江省基本公共卫生服务规范》（第四版）制定，兼顾全人全程档案设计需求、疾控业务条线需求，实现电子健康档案收集、存储、发布、交换等应用中的一致性和规范性，保证数据的有效交换和共享。 以电子健康档案数据采集为目标，从拓扑结构、数据集含义、约束关系数据集字段等方面进行规范。电子健康档案基本档案数据集包含家庭基本信息、家庭主要问题、个人基本信息、个人既往史、个人疾病史、个人手术史、个人外伤史、个人输血史、个人家族史、居住地址编码、档案开放记录等。

Data Transmission Specification of Electronic Health Record —Part Two：Dataset of Basic Records

T/ZJHIA 03-2022 电子处方数据传输规范

根据浙江省内全民健康信息互通共享和实施浙江省数字化改革开展处方流转服务等有关要求，以电子处方数据采集与流转为目标，规定了电子处方数据传输的相关术语和定义，传输流程、处方信息要求、数据传输通过接口方式、电子处方数据集规范等技术相关标准要求，实现电子处方收集、存储、发布、交换等应用中的一致性和规范性，保证数据的有效交换和共享。

Electronic prescription data transmission specification

T/ZJHIA 01-2022 医疗物联网设备安全管控基本要求

适用范围：全医疗行业关于物联网设备、医疗器械设备等相关场景； “摸清家底”：通过相关技术手段对医院IoMT设备进行发现和识别，梳理出CT机、DR机、PDA查房终端等具体设备类型，并识别出西门子、GE、飞利浦、迈瑞医疗等具体厂商品牌，在此基础上标注出设备所属科室、位置，并建立起医院的物联网设备台账； “发现风险”：通过扫描等方式发现IoMT设备自身的安全隐患，包括但不限于设备漏洞、弱口令、配置风险等等，同时将IoMT设备与数据中心各业务系统服务器的网络交互行为进行监测，以确保设备为安全运行状态，一旦出现异常行为能够快速发现并告警。 “有效管控”：通过准入技术对所有新接入设备进行身份合法性确认，只有医院新采购设备才能审批入网，外部可疑设备或仿冒替换设备无法接入医院网络。 “闭环处置”：通过统一的管理平台，能够监测IoMT运行安全状态，并在发现威胁或异常后能够远程进行快速联动处置。

Basic requirements for security control of medical IoT devices

T/ZJHIA 02.1-2022 电子健康档案数据传输规范 第1部分：总则

根据浙江省内全民健康信息互通共享和实施浙江省数字化改革开展电子健康档案共享等有关要求，通过建立电子健康档案数据传输规范，建立全人全程的电子健康档案数据中心，促进健康档案的共享调阅和便民惠民服务的开展。 依据《浙江省基本公共卫生服务规范》（第四版）制定，兼顾全人全程档案设计需求、疾控业务条线需求，实现电子健康档案收集、存储、发布、交换等应用中的一致性和规范性，保证数据的有效交换和共享。 以电子健康档案数据采集为目标，描述各市、县（市、区）传输电子健康档案的两种方式：中间库方式和接口方式，对市、县（市、区）电子健康档案系统对接省级电子健康档案系统的模式进行定义。同时对数据格式、格式示例、值域、多选字段定义、多条记录定义进行说明。

Data Transmission Specification of Electronic Health Record—Part One：General Principles

T/ACSC 02-2022 中医医院建筑设计规范

中医医院的医疗工艺设计；中医医院的选址、用地与总平面；中医医院的建筑设计与中医文化设计；中医医院的给排水、消防和污水处理；供暖、通风及空调系统；中医医院的电气；中医医院的智能化系统；中医医院的医用气体系统。

Code for Design of Chinese Medicine Hospital

T/ACSC 01-2022 辅助生殖医学中心建设标准

医疗工艺基本要求；医疗设备装备基本要求；建筑装饰基本要求；信息与智能化系统基本要求；空气调节与净化基本要求；医用气体基本要求；给水排水基本要求；电气基本要求；消防基本要求；施工管理验收基本要求；日常运行管理维护保养基本要求。

Standard for the construction of assisted reproductive medicine centers

ASTM F1671/F1671M-22 用Phi-X174噬菌体穿透作为试验系统的防护服材料抗血源性病原体穿透性的标准试验方法

1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by bloodborne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration. 1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the liquid assay fluid. 1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications. 1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other pathogens must be assessed on a case-by-case basis. 1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing and determined to be viral resistant. This test method does not address the design, overall construction and components, or interfaces of garments or other factors which may affect the overall protection offered by the protective clothing. 1.5 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 1.6 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. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the 1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.40 on Biological. Current edition approved Jan. 1, 2022. Published January 2022. Originally approved in 1995. Last previous edition approved in 2013 as F1671/F1671M – 13. DOI: 10.1520/F1671_F1671M-22. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

ASTM E2280-21 医疗设施病房内软垫座椅家具效果的火灾危险评估标准指南

1.1 This is a guide to developing fire hazard assessments for upholstered seating furniture, within patient rooms of health care occupancies. As such, it provides methods and contemporary fire safety engineering techniques to develop a fire hazard assessment for use in specifications for upholstered seating furniture in such occupancies. 1.2 Hazard assessment is an estimation of the potential severity of the fires that can develop with certain products in defined scenarios, once the incidents have occurred. Hazard assessment does not address the likelihood of a fire occurring, but is based on the premise that an ignition has occurred. 1.3 Because it is a guide, this document cannot be used for regulation, nor does it give definitive instructions on how to conduct a fire hazard assessment. 1.4 This guide is intended to provide assistance to those interested in mitigating the potential damage from fires associated with upholstered furniture in patient rooms in health care occupancies. 1.5 Thus, this guide can be used to help assess the fire hazard of materials, assemblies, or systems intended for use in upholstered furniture, by providing a standard basis for studying the level of fire safety associated with certain design choices. It can also aid those interested in designing features appropriate to health care occupancies. Finally, it may be useful to safety personnel in health care occupancies. 1.6 This guide is a focused application of Guide E1546, which offers help in reference to fire scenarios that are specific to upholstered furniture in health care occupancies, and includes an extensive bibliography. It differs from Guide E1546 in that it offers guidance that is specific to the issue of 1 This guide is under the jurisdiction of ASTM Committee E05 on Fire Standards and is the direct responsibility of Subcommittee E05.15 on Furnishings and Contents. Current edition approved Dec. 15, 2021. Published January 2022. Originally approved in 2003. Last previous edition approved in 2017 as E2280-17. DOI: 10.1520/E2280-21. *A Summary of Changes section appears at the end of this standard Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 upholstered furniture in patient rooms of health care facilities, rather than general guidance. Appendix X11 includes some statistics on the magnitude of the potential problem in the U.S. 1.7 A fire hazard assessment conducted in accordance with this guide is strongly dependent on the limitations in the factors described in 1.7.1 – 1.7.4. 1.7.1 Input data (including their precision or accuracy). 1.7.2 Appropriate test procedures. 1.7.3 Fire models or calculation procedures that are simultaneously relevant, accurate and appropriate. 1.7.4 Advancement of scientific knowledge. 1.8 This guide addresses specific fire scenarios which begin inside or outside of the patient room. However, the upholstered furniture under consideration is inside the patient room. 1.9 The fire scenarios used for this hazard assessment guide are described in 9.2. They involve the upholstered furniture item within the patient room as the first or second item ignited, in terms of the room of fire origin. Additionally, consideration should be given to the effect of the patient room upholstered furniture item on the tenability of occupants of rooms other than the room of fire origin, and on that of potential rescuers. 1.10 This guide does not claim to address all fires that can occur in patient rooms in health care occupancies. In particular, fires with more severe initiating conditions than those assumed in the analysis may pose more severe fire hazard than that calculated using this guide (see also 9.5). 1.11 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.12 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. 1.13 This fire standard cannot be used to provide quantitative measures. 1.14 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 Fire Hazard Assessment of the Effect of Upholstered Seating Furniture Within Patient Rooms of Health Care Facilities

T/GDMDMA 0012.2-2021 医院医疗器械管理规范 第2部分：调配中心运行管理

本文件规定了医院医疗器械调配中心运行管理的基本要求，包括人员组成、管理职责、人员要求、管理制度、信息管理系统要求、工作场地要求、配置要求和应急预案。

Medical equipment standardized management in hospital - Part 2：Operation and management of allocation center

T/STIC 110065-2021 分支型主动脉覆膜支架及输送系统

本文件规定了分支型主动脉覆膜支架及输送系统的术语和定义、技术要求、检验方法、检验规则、标志、标签、使用说明书、包装、运输和储存的要求。 本文件为分支型主动脉覆膜支架及输送系统生产企业提供技术规范。

Branched Aortic Stent-Graft System

ASTM E2361-13(2021) 使用现场方法对产品进行试验的标准指南

1.1 This guide covers test methods and sampling procedure options for leave-on products for consumer and hospital personnel. Leave-on products, such as alcohol hand rubs and lotions containing antimicrobial ingredients, are increasingly marketed and used by consumers and health care personnel. These products are distinguished from conventional washing and scrubbing preparations in that they do not rely on the rinsing, physical removal, and antimicrobial action in determining their effectiveness. Although agitation and friction may serve to release organisms from the skin and folds and crevices, organisms are then killed in situ and are not rinsed from the skin surface before sampling. Appropriate test methods for the hands have been published, while other sampling methods will be needed for testing body areas other than the hands. 1.1.1 Researchers have described techniques to identify the expanded flora we now know can be present on the skin. It is impractical, if not prohibitive to attempt to recover and identify these varieties of organisms with each test. At some point in the design of a test, a decision is necessary for defining the target organisms. Should the sampling be designed to recover as much of the microflora as possible or a particular portion of it? Consideration of transient and resident, superficial and deep, or aerobic and anaerobic flora must be included in defining the objective in testing products. The recovery methods selected for any testing must be based on the projected use of the product type being tested. 1.2 Methods of recovery after application of the contaminating organisms to a part of the body other than by the agitation/rubbing of the hands against a glass petri plate also need examination. Consideration should be given to contact plating, controlled swabbing with a template, and cup scrubbing (detergent/agitation used) since the target organisms for recovery are likely to be on the superficial layers of skin. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 Testing Leave-On Products Using In-Situ Methods

T/NAHIEM 36-2021 体外诊断经营（流通）企业团体标准

本标准规定了医学实验室体外诊断试剂流通领域关于试剂冷链物流至仓储到交付全过程的整体操作流程规范（包含信息自动化）的要求和操作要点。

In-vitro diagnostic management (distribution) enterprise group standards

YY/T 1780-2021 医用个人防护系统

Medical personal protection system

GSO ASTM D7103:2021 医用手套评估标准指南

1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards. 1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk. 1.3 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. 1.4 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 Assessment of Medical Gloves

GSO ASTM D7102:2021 无菌医用手套内毒素测定标准指南

1.1 This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate. 1.2 As bacteria may continue to grow on non-sterile gloves, reportable endotoxin levels are only appropriate for gloves labeled as sterile. Because most environments contain endotoxin, once a box of gloves is opened and the gloves are manipulated, endotoxin levels will increase making it inappropriate to report endotoxin levels on boxed gloves (ex. examination gloves). This is true even if the box had undergone sterilization prior to distribution. 1.3 This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations. 1.4 This guide is not applicable to the determination of pyrogens other than bacterial endotoxins. 1.5 The sample preparation method described must be used regardless of the test method selected. This method does not describe laboratory test method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed. 1.6 The safe and proper use of medical gloves is beyond the scope of this guide.

Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

GSO ASTM D6124:2021 医用手套上残留粉末的标准测试方法

1.1 This test method covers the determination of average powder or filter-retained mass found on a sample of medical gloves as described in the introduction. 1.2 The average powder mass per glove is reported in milligrams. 1.3 The safe and proper use of medical gloves is beyond the scope of this test method. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 and health 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 Test Method for Residual Powder on Medical Gloves