ISO 20342-1:2019 躺下时组织完整性辅助产品 第1部分：一般要求

标准编号：ISO 20342-1:2019

中文名称：躺下时组织完整性辅助产品 第1部分：一般要求

英文名称：Assistive products for tissue integrity when lying down — Part 1: General requirements

发布日期：2019-06

标准范围

本文件规定了在医院、家庭护理和机构等不同应用环境中，与卧位组织完整性辅助产品（APTI）相关的一般要求和相关测试方法。本文件适用于APTI的安全性，其目的是在躺着期间保持原位，并预防和/或治疗压力伤害。本文件涵盖了一系列不同的支撑面，拟与适当的支撑平台结合使用，或作为一个整体集成系统使用。本文件还包括主要用于改变卧位的组织完整性的辅助产品和用于保持卧位的辅助产品。本文件不适用于与培养箱结合使用的躺着支撑面。本文件介绍了全身支撑面和可调节床垫支撑平台的组合。它还包括安全和性能测试方法，以确保保护用户免受伤害。本文件在ISO 9999:2016的以下分类中规定了APTI的要求和试验方法:04 33 06躺下时保持组织完整性的辅助产品，包括但不限于:-用于预防压力伤害的床垫和床垫覆盖物；-用于防止压力伤害的床垫覆盖物。12 31 03用于滑动和转动的辅助产品，包括但不限于:使用滑动或旋转技术改变人的位置或方向的装置。包括的唯一产品是那些打算在躺着位置使用并作为躺着支撑表面的一部分保持原位的产品。它们是:-滑动产品，单向滑动，反向锁定；-低摩擦柔性材料的薄板和衬垫；-按米出售的织物，按照重新定位使用的要求切割；-电动车削产品；这不包括滑板，除非产品打算留在原地。09 07 06定位枕头、定位垫和定位系统，包括但不限于:-腿定位器，-臂定位器，以及-多用途身体定位器。18 12 15垫层，包括但不限于:-画床单。

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, which 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 or as a whole integrated system.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.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 9999:2016:04 33 06 Assistive products for tissue integrity when lying down such as but not limited to:— Mattresses and mattress overlays for pressure injury prevention;— Mattress coverings for pressure injury prevention mattresses.12 31 03 Assistive products for sliding and turning such as but not limited to: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.

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