11.140 医院设备 标准查询与下载

YY/T 1106-2023 电动手术台

本文件规定了电动手术台的性能要求和试验方法。本文件适用于电动手术台。

Electric operating table

23/30457009 DC BS EN 455-2 一次性医用手套 第 2 部分：物理性能要求和测试

BS EN 455-2. Medical gloves for single use - Part 2. Requirements and testing for physical properties

T/GDC 195-2022 临床用血信息系统技术规范

临床用血信息系统的总体要求、血液库存管理、输血管理、自体输血、输血治疗、统计与分析、知识库与考核、信息安全、维护与保障

Technical specification for clinical blood information system

T/CIS 11002-2022 陡脉冲治疗仪电磁环境现场测量和评价方法

目 次 前 言 …………………………………………………………………………………………………… Ⅱ 1 范围 ……………………………………………………………………………………………………… 1 2 规范性引用文件 ………………………………………………………………………………………… 1 3 术语和定义 ……………………………………………………………………………………………… 1 4 测量指标 ………………………………………………………………………………………………… 2 5 测量和评价原理 ………………………………………………………………………………………… 2 6 测量仪器 ………………………………………………………………………………………………… 2 7 测量方法 ………………………………………………………………………………………………… 2 7.1 环境条件 ………………………………………………………………………………………… 2 7.2 测量点布置平面图绘制 ………………………………………………………………………… 2 7.3 测量点设置 ……………………………………………………………………………………… 2 7.4 测量步骤 ………………………………………………………………………………………… 3 8 结果处理 ………………………………………………………………………………………………… 3 8.1 计算流程 ………………………………………………………………………………………… 3 8.2 计算方法 ………………………………………………………………………………………… 4 9 评价 ……………………………………………………………………………………………………… 5 9.1 同一测量点背景电磁环境数据与工作状态电磁环境数据的比较 …………………………… 5 9.2 不同测量点工作状态电磁环境数据的比较 …………………………………………………… 5 10 测量报告 ……………………………………………………………………………………………… 5 附 录 …………………………………………………………………………………………………… 7 参考文献 …………………………………………………………………………………………………… 10

In-situ measurement and evaluation methods for electromagnetic environment of steep pulses therapy instrument

ASTM F2407/F2407M-22a 医疗保健设施用外科手术服标准规范

1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes. NOTE 1—Some properties require minimum performance and others are for documentation only. NOTE 2—ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown. 1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. 1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as the basis for selecting test requirements. 1.4 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. 1.5 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 This specification 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 Nov. 15, 2022. Published December 2022. Originally approved in 2006. Last previous edition approved in 2022 as F2407/F2407M – 22. DOI: 10.1520/F2407_F2407M-22A. 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 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 Specification for Surgical Gowns Intended for Use in Healthcare Facilities

T/GZBC 60-2022 新冠病毒核酸采样信息智能化采集规范

本标准规定了新冠病毒核酸采样信息采集的基本原则、智能化采集要求、信息采集程序、采集信息内容以及信息上报要求。 本标准适用于新冠病毒核酸采样信息的智能化采集。

Specification of SARS-COV-2 nucleic acid sampling information intelligent collection

T/HBSYYXH T/HBSYYXH0001-2022 医院智慧后勤建设与运行维护指南

本文件规定了医院智慧后勒建设与运行的通用要求、规划设计与运行维护要求、后勤外包服务体系与质量控制、智慧后勒管理平台建设配置要求智慧后勒业务应用系统和 BIM运用要求本文件适用于各级各类医院后勤建设和运行维护管理。

Guide to the construction and operation of intelligent logistics in hospitals

ASTM D3738-16(2022) 橡胶涂层布医院床单标准规范

1.1 This specification covers rubber-coated cloth sheeting intended for use in the protection of mattresses on hospital beds. 1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.3 The following safety hazards caveat pertains only to the test methods portion, Section 9, of this specification. 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 Specification for Rubber-Coated Cloth Hospital Sheeting

ASTM F2407/F2407M-22 医疗设施用外科手术服标准规范

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

ASTM F2076-01(2022) EMS病人报告关于接收医疗设备的通知的标准实施规程

1.1 This practice establishes the EMS standard for communications entailing a patient radio (phone) report to a receiving medical facility. 1.1.1 This report is based on receiving facility needs and is generic for medical, traumatic (ALS), and (BLS) patients. 1.1.2 This report standard is based on the hierarchical information needs of an average medical receiving facility. 1.2 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 Practice for Communicating an EMS Patient Report to Receiving Medical Facilities

ASTM F2101-22 使用金黄色葡萄球菌生物气溶胶评估医用口罩材料细菌过滤效率（BFE）的标准试验方法

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 do 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. 1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the standard. 1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material. 1.7 This test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such as surgical gowns, surgical drapes, and sterile barrier systems. 1.8 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. 1.9 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 Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

T/QZZN 03-2022 医用红外热像仪

本文件规定了医用红外热像仪的产品型号和基本参数、技术要求、试验方法、检验规则、标志、包装、运输与贮存。 本文件适用于医用红外热像仪（以下简称红外热像仪）。

Medical Infrared Camera

T/CAME 44-2022 医用电动移位车

本文件规定了医用电动移位车的标记、技术要求、试验方法、检验规则、标志、包装、贮存、运输和交付、使用中的注意事项。 本文件适用于医疗卫生机构中危重和活动受限人员在各种床体之间转移时使用的电动移位车,养老机构中老人在各种床体之间转移时使用的电动移位车可参照执行。

Medical electric transfer vehicle

T/ZZB 2735-2022 医用一次性防护服

本文件规定了医用一次性防护服的基本要求、技术要求、试验方法、检验规则、标志、使用说明、包装、运输和贮存、质量承诺等要求。 本文件适用于为医务人员在工作时接触具有潜在感染性的患者血液、体液、分泌物、空气中的颗粒物等提供阻隔、防护作用的医用一次性防护服（以下简称 “防护服”） 。 本文件不适用于具有阻燃性能的防护服。

Single-use protective clothing for medical use

ASTM D7102-17(2022) 无菌医用手套上内毒素测定的标准指南

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. 1.7 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. 1.8 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 Determination of Endotoxin on Sterile Medical Gloves

ASTM D6124-06(2022) 医用手套上残留粉末的标准试验方法

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, 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 Test Method for Residual Powder on Medical Gloves

ASTM D6355-07(2022) 医用手套的人体重复损伤贴片试验的标准试验方法

1.1 This test method is designed to evaluate the potential of glove materials under test to induce and elicit Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans. 1.2 This test method should be used by individuals experienced in or under the supervision of those experienced in the use of good clinical practice procedures. 1.3 During the performance of the Human Repeat Insult Patch Test (RIPT) for determining sensitization, investigators are confronted with skin responses that represent skin irritation (non-immunologic responses) or allergic contact dermatitis (ACD). The numerical scoring system for grading the intensity of both are similar and test facilities may vary in their scores that describe intensities of allergic and irritant skin responses. The hallmark of a mild allergic contact dermatitis is a sustained palpable erythematous reaction. Delayed-type allergic contact reactions from patch tests have intensity characteristics that favor scores of higher values for longer periods of time and typically do not produce a minimal score (score of 1, a just-perceptible erythema) for short durations (less than 48 h). It is the responsibility of the investigator to evaluate the scores in light of irritant reactions so that the responses are allergic in nature and not irritant. The investigator should denote a final score as either due to contact allergy or irritation. Paragraphs 9.5 – 9.5.5 describe a commonly used scoring system and discuss allergic and irritant responses in detail. 1.4 The Draize RIPT was published in 1944 as an attempt to decrease the frequency ACD.2 The test techniques at that time were just being validated and this experimental design was largely empiric.3 The principle of the test is as follows: 1.4.1 Multiple inductions of the study material at relatively non or low irritancy levels, 1.4.2 Approximately a two-week rest period, and 1.4.3 A standard diagnostic challenge of approximately 48 h and a delayed reading at approximately 96 h after patch application. 1.5 In the intervening years, with further experimentation added to this empiric approach, three additional principles have been learned: 1.5.1 Increasing the concentration of the study material, 1.5.2 Defining a no effect level (this is possible with only individual ingredients and not the final study material), and 1.5.3 The enhanced sensitivity and the use of occlusion (where occlusion would not ordinarily be present). 1.6 In 1945, Henderson and Riley4 demonstrated that a test panel sample size of 30 000 subjects would have to be employed to ensure statistically that there would be no more than 0.1 % sensitization. If there are no allergic responses in a test panel of 200 subjects with exposures comparable to those of the population, then there could be as many as 1.5 allergic reactions per 100 users. 1.7 All medical devices must be safe and effective for their intended use. Since medical devices such as gloves come in contact with human tissue, they should be tested for biocompatibility in animals first. The human repeat insult patch test (RIPT) is one test that can be used to test rubber gloves for skin sensitization to chemicals used in the manufacture of gloves. 1.7.1 Since various forms of the RIPT exist, a single standardized test method that outlines the testing protocol, scoring system, and the criteria for skin sensitization should be developed. 1.8 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. 1.9 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 D11 on Rubber and Rubber-like Materials and is the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products. Current edition approved June 1, 2022. Published July 2022. Originally approved in 1998. Last previous edition approved in 2017 as D6355 – 07 (2017). DOI: 10.1520/D6355-07R22. 2 Draize, J.H., Woodward, G., and Calvery, H.O., “Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes,” Journal of Pharmacology and Experimental Therapeutics, Vol 83, 1944, pp. 377-390. 3 Shelanski, H. A., and Shelanski, M. V., “A New Technique of Human Patch Test,” Proc. Sci. Sect. Toilet Goods Assoc. , Vol 19, 1953, pp. 46-49. 4 Henderson, C. R., and Riley, E. C., “Certain Statistical Considerations in Patch Testing,” Journal of Investigative Dermatology , Vol 6, 1945, pp. 227-232. 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 Human Repeat Insult Patch Testing of Medical Gloves

T/ZZB 2728-2022 医用外科口罩

本文件规定了医用外科口罩（以下简称“口罩”） 的术语和定义、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。 本文件适用于含有潜在血液、体液、分泌物污染风险的医疗环境及有创操作环境使用的一次性医用口罩。 本文件不适用于医用防护口罩以及其他工作环境下的防护口罩。

Surgical mask

DB4212/T 52-2022 桂花早产丰产栽培技术规程

Premature and High Yield Cultivation Regulations of Osmanthus fragrans

DB4212/T 50-2022 咸宁林下“135”生态养鸡技术规程

Xianning Forest "135" Technical Regulations for Ecological Chicken Raising