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作废 ASTM F1556-94(2015)
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Standard Guide for Spinal Immobilization and Extrication (SPINE) Device Characteristics (Withdrawn 2024) 脊柱固定和提取标准指南(SPINE)装置特征
发布日期: 2015-06-01
废止日期: 2024-01-03
1.1 本指南涵盖了设备的最低标准,在此指定为脊柱固定和解脱设备(脊柱),通常称为短脊柱板。SPINED被设计为急救医疗服务人员固定和解救潜在脊柱或脊髓损伤患者的平台。 1.2 本指南不确定通过在患者身上放置棘突来实现的特定运动限制程度。医学文献中尚未确定脊柱固定的明确要求,尤其是与使用脊柱固定相关的限制程度。 1.3 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 本指南的目的是确定棘突光纤应具备的特性。 4.2 与全身脊柱固定装置不同,SPINED具有其他功能,有助于将受害者从密闭空间中解救出来。 4.3 预计SPINED不会单独用于提供所需固定的整个范围。临床情况可能需要不同的设备组合以实现充分的全脊柱固定。 脊椎装置可以是其中之一。 4.4 用于成年患者的设备应适合第95百分位成年美国男性。 4.5 标记为拟用于儿科的设备不得用于容纳成年患者。 4.6 该装置应能够由从业人员以符合人体工程学的方式使用。
1.1 This guide covers minimum standards for devices, designated here as spinal immobilization and extrication device(s) (SPINED), commonly referred to as short spine board. The SPINED is designed to be used as the platform for immobilization and extrication of a patient with potential spine or spinal cord injury by emergency medical service personnel. 1.2 This guide does not identify specific degrees of limitation of motion achieved by placement of a SPINED on a patient. Definitive requirements for immobilization of the spine, and, in particular, the degree of limitation associated with the use of a SPINED, have not been established in the medical literature. 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 The intent of this guide is to identify characteristics that a SPINED shall possess. 4.2 As opposed to a full body spinal immobilization device, the SPINED incorporates additional features that assist in the extrication of a victim from a confined space. 4.3 It is not expected that the SPINED will be used alone to provide the entire scope of required immobilization. Clinical situations may require differing combinations of devices for adequate total spinal immobilization. A SPINE device may be one of the devices. 4.4 A device intended for use with adult patients shall accommodate the 95th percentile adult American male. 4.5 Devices that are labeled as intended for pediatric use shall not be required to accommodate adult patients. 4.6 The device shall be able to be used by the practitioner in an ergonomically sound manner.
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归口单位: F30.01
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