1.1本规范规定了医疗设施中使用的手术服的性能、文件和标签要求。AAMI规定了手术服的四级屏障性能 PB70 并包含在本规范中，以供参考。 注1 — 一些属性要求最低性能，其他属性仅用于文档。 注释2 — AAMI公司 PB70 仅在1、2和3级使用水评估手术服织物的阻隔性能。由于手术服暴露于具有不同表面张力的血液和其他液体中，因此需要对4级手术服进行额外测试，以确定对模拟生物液体的屏障水平。 1.2本规范不涵盖医疗机构认为选择产品所需的所有要求，也不涉及评估实验产品的标准。 1.3本规范无意作为详细的制造或采购规范，但可在采购规范中参考，作为选择测试要求的依据。 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独立于其他系统使用，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）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1本规范规定了用于保护可能接触血液、体液和其他潜在感染性物质的医护人员的手术服的要求。 该规范要求根据AAMI中建立的礼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制定了手术服的一般安全要求。对重要物理性能（包括抗拉强度、抗撕裂性、接缝强度、抗起毛性、耐蒸发性测试和水蒸气透过率）设定了文件和报告要求。 4.2本规范不涉及用于非手术应用的防护服，如隔离服或去污服；手部防护服，如手术手套、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、手术口罩或呼吸器； 脚防护服，如手术室鞋、鞋套或手术靴；或医疗保健提供者穿戴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关于手术服性能和功效的声明提供依据。对于多用途手术服，本规范考虑了这些产品的预期护理和维护，通过检查洗涤和灭菌最大预期周期前后手术服材料的测试要求。 4.4 AAMI中提供了有关多用途手术服处理的其他信息 ST65型 . 4.5手术服根据AAMI中规定的屏障性能进行分类 PB70 本规范规定了手术服及其材料的某些其他物理性能和文件要求。还提供了手术服的设计要求和建议。 4.6 AAMI中提供了关于测试、选择和使用手术服的其他信息 TIR11 . 附注3 — AAMI障碍物等级信息 TIR11 目前与AAMI中建立的水平不匹配 PB70 . 然而，AAMI TIR11 提供其他有用信息，以帮助选择和使用手术服。

1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. Four levels of barrier properties for surgical gowns are specified in 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 — 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 This specification provides 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 AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Documentation and reporting requirements are set for important physical properties including tensile strength, tear resistance, seam strength, linting resistance, evaporative resistance testing, and water vapor transmission rate. 4.2 This specification does not address protective clothing used for non-surgical 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 health care 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 AAMI ST65 . 4.5 While surgical gowns are classified for barrier performance as specified in AAMI PB70 , this specification establishes certain other physical performance and documentation requirements for surgical gowns and their materials. Design requirements and recommendations are also provided for surgical gowns. 4.6 Additional information for the testing, selection, and use of surgical gowns is provided in AAMI TIR11 . Note 3 — Information on barrier classes in AAMI TIR11 does not currently match the levels established in AAMI PB70 . However, AAMI TIR11 provides other useful information that is intended to aid in the selection and use of surgical gowns.