1.1 本规范规定了医疗机构中使用的手术服的性能、文件和标签要求。ANSI/AAMI规定了手术服的四个等级的阻隔性能 PB70，并包含在本说明书中以供参考。 注1: 某些属性要求最低性能，而其他属性仅用于文档。 注2: 安西语/萨米语 PB70仅在1、2和3级中评估使用水的手术服织物的阻隔性能。由于手术服暴露在具有不同表面张力的血液和其他流体中，4级手术服需要进行额外测试，以确定模拟生物流体的屏障水平。 1.2 本规范未涵盖医疗机构认为选择产品所必需的所有要求，也未涉及评估实验产品的标准。 1.3 本规范不打算作为详细的制造或采购规范，但可以在采购规范中参考，作为选择测试要求的基础。 1.4 以国际单位制或其他单位表示的数值应单独视为标准。每个系统中规定的值必须相互独立使用，不得以任何方式组合值。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 4.1 本规范规定了用于保护可能接触血液、体液和其他潜在传染性物质的医护人员的手术服的最低要求。该规范要求根据ANSI/AAMI中建立的防护服分类系统进行屏障测试 PB70，并基于生物相容性、无菌保证和火焰传播为手术服制定了一般安全要求。为重要的物理性能制定了性能要求，包括抗拉强度、撕裂强度和接缝强度。提供了用于选择性报告耐起毛性、耐蒸发性、水蒸气透过率和耐磨性性能的方法。 4.2 本规范未涉及非手术应用的防护服，如隔离服或去污服； 手部防护服，如外科手套、患者检查手套或其他医用手套；头部防护服，如护目镜或面罩、手术帽或面罩、外科口罩或呼吸器；足部防护服，如手术室鞋、鞋套或手术靴；或医疗保健提供者所穿的其他类型的防护服和设备。 4.3 手术服是制造商指定的多用途或一次性产品。本规范旨在为制造商对手术服性能和功效的声明提供依据。对于多用途手术服，本规范通过在清洗和灭菌的最大预期循环次数之前和之后检查手术服材料的测试要求，考虑了这些产品的预期护理和维护。 4.4 关于处理多个- 使用外科手术服在ANSI/AAMI中提供 第65条。 4.5 手术服按照ANSI/AAMI的规定进行屏障性能分类 PB70，本规范规定了手术服及其材料的其他设计标准、最低物理性能标准、标签和文件要求。 4.5.1 除了手术服材料和接缝的阻隔性能外，手术服材料与接缝还需要满足拉伸强度、撕裂强度和接缝强度的最低要求，这些要求是在工作场所要求分析的基础上制定的。具有不同屏障等级声明的手术服应满足相同的最低强度要求，无论其屏障等级如何。 4.5.2 手术服材料的其他性能，如皮棉生成、耐蒸发性或水蒸气传输率和耐久性，可用于记录性能的测试。 这些属性没有制定最低标准，但购买者可以使用这些信息来比较产品。 4.5.3 手术服与隔离服的不同之处在于其预期用途和液体接触的预期位置。规范中规定了隔离衣材料和接缝的阻隔性能以外的隔离衣的具体要求 F3352/F3352米 。 4.6 AAMI中提供了有关手术服测试、选择和使用的其他信息 提尔11。

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. 1.6 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. ====== Significance And Use ====== 4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Performance requirements are established for important physical properties, including tensile strength, tear strength, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, and abrasion resistance are provided. 4.2 This specification does not address protective clothing used for nonsurgical applications, such as isolation gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers. 4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization. 4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65. 4.5 While surgical gowns are classified for barrier performance as specified in ANSI/AAMI PB70, this specification establishes other design criteria, minimum physical performance criteria, labeling, and documentation requirements for surgical gowns and their materials. 4.5.1 In addition to the barrier performance of the surgical gown material and seams, surgical gown material and seams are also required to meet minimum requirements for tensile strength, tear strength, and seam strength that have been established on the basis of an analysis of workplace requirements. Surgical gowns with different barrier level claims shall meet the same minimum strength requirements regardless of their barrier level. 4.5.2 Additional properties for surgical gown material such as lint generation, evaporative resistance or water vapor transmission rate, and durability are optional for testing for the purpose of documenting performance. No minimum criteria are established for these properties, but purchasers may use this information to compare products. 4.5.3 Surgical gowns differ from isolation gowns based on their intended use and anticipated location of liquid contact. Specific requirements for isolation gowns beyond the barrier performance of isolation gown materials and seams are provided in Specification F3352/F3352M . 4.6 Additional information for the testing, selection, and use of surgical gowns is provided in AAMI TIR11.