躺下时组织完整性辅助产品.第1部分:一般要求

[中文适用范围]： 本文件规定了医院、家庭护理和机构等不同应用环境中卧位组织完整性辅助产品（APTI）的一般要求和相关测试方法。 本文件适用于 APTI 的安全性，APTI 旨在在躺卧期间保持在原位，并预防和/或治疗压力损伤。 本文件涵盖了一系列不同的躺卧支撑表面，旨在与适当的支撑平台（包括可调节的）结合使用或作为整个集成系统使用。 本文件不适用于医疗床。 本文件还涵盖主要用于改变卧位的组织完整性的辅助产品和用于维持卧位的辅助产品。 本文件不适用于与培养箱或手术/手术台结合使用的卧式支撑表面。 它还涵盖安全和性能测试方法，以确保防止用户受伤。 本文件涉及全身支撑表面和可调节床垫支撑平台的组合。 它还涵盖安全和性能测试方法，以确保防止用户受伤。 本文件规定了 043306 躺下时组织完整性辅助产品的以下分类中 APTI 的要求和测试方法，例如但不限于 - 用于预防压力损伤的床垫和床垫覆盖层，以及 - 用于预防压力损伤床垫的床垫覆盖物。 123103 用于滑动和转动的辅助产品，例如但不限于以下产品： 使用滑动或转动技术改变人的位置或方向的装置。 所包含的唯一产品是那些旨在以躺姿使用并作为躺卧支撑表面的一部分保留在原位的产品。 它们是： ——向一个方向滑动并向另一个方向锁定的滑动产品； ——低摩擦柔性材料制成的板材和衬垫； ——按米出售的织物，根据重新定位使用的需要进行裁剪； ——动力转动产品；这不包括滑板，除非产品打算留在原处。 090706 定位枕头、定位垫和定位系统，例如但不限于 — 腿部定位器、1 — 手臂定位器和 — 多用途身体定位器。 181215 床上用品，例如但不限于——床单。 [外文原描述]： This document specifies general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care and institutions. This document applies to the safety of APTI that are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries. This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform (adjustable included) or as a whole integrated system. This document does not apply to medical beds. This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position. This document does not apply to lying support surfaces used in combination with incubators or operating/surgical tables. It also covers safety and performance test methods to ensure protection against injuries to the user. This document addresses the combination of a full body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user. This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2022: 04 33 06 Assistive products for tissue integrity when lying down such as but not limited to — mattresses and mattress overlays for pressure injury prevention, and — mattress coverings for pressure injury prevention mattresses. 12 31 03 Assistive products for sliding and turning such as but not limited to the following: Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following: — sliding products that glide one way and lock the other way; — sheets and underlays in flexible materials with low friction; — fabric sold by the metre, cut as required for repositioning use; — powered turning product; This excludes sliding boards unless the product is intended to be left in situ. 09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to — leg positioners, — arm positioners, and — multipurpose body positioners. 18 12 15 Bedding such as but not limited to — draw sheets.