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现行 ASTM F3352/F3352M-23b
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Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities 医疗设施用隔离服的标准规范
发布日期: 2023-06-01
1.1 本规范规定了医护人员使用隔离服的性能和标签的最低要求,以提供标准和基于传播的预防措施的保护。本规范的预期用途是确保隔离衣的性能,以保护穿着者。ANSI/AAMI PB 70中规定了隔离服的四个等级的屏障性能,并包含在本规范中以供参考。 1.2 还有其他类型的罩袍可用于医疗保健环境,包括:罩袍、手术罩袍、舒适罩袍、预防罩袍和露背罩袍。所有不符合隔离服定义的长袍 3.1.7 如ANSI/AAMI PB70所定义的,不包括在本标准中。 1.3 本规范未涉及用于外科应用的防护服,如手术服或去污服; 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。 1.4 单位- 以国际单位制或英寸磅单位表示的数值应单独视为标准。每个系统中规定的值可能不是完全相等的;因此,每个系统应独立使用。将两个系统的值结合起来可能会导致不符合标准。 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。
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes. 1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard. 1.3 This specification does not address protective clothing used for surgical applications, such as surgical 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. 1.4 Units— The values stated in either 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 with the 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.
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发布单位或类别: 美国-美国材料与试验协会
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归口单位: F23.40
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