11.180.01 残障人员用设备综合 标准查询与下载

EN ISO 21801-2:2022 认知可及性-第2部分:报告

This document specifies requirements for reporting the cognitive accessibility of systems, including assistive products, assistive technologies, consumer technologies, and household appliances, according to the recommendations given in ISO 21801-1:2020.

Cognitive accessibility - Part 2: Reporting (ISO 21801-2:2022)

KS P 8415-2022 上肢:假肢用化妆手套

Upper Limb: Cosmetic gloves for prosthetic hands

T/CARD 033-2022 孤独症儿童家庭实施早期干预指南

Early Intervention Guidelines for Families of Children with Autism

ISO 21801-2:2022 认知可及性-第2部分:报告

This document specifies requirements for reporting the cognitive accessibility of systems, including assistive products, assistive technologies, consumer technologies, and household appliances, according to the recommendations given in ISO 21801-1:2020.

Cognitive accessibility — Part 2: Reporting

ISO/CD 20342-3 躺下时组织完整性的辅助产品 第3部分：强度和影响

Assistive products for tissue integrity when lying down — Part 3: Strength and impact

ISO/CD 20342-5 躺下组织完整性用辅助用品第5部分：耐清洁消毒

Assistive products for tissue integrity when lying down — Part 5: Resistance to cleaning and disinfection

IEC 60050-872:2022 国际电工词汇（IEV）第872部分：辅助功能

International Electrotechnical Vocabulary (IEV) – Part 872: Accessibility

T/CAAP 025-2022 脑机接口手功能康复训练系统

规定了脑机接口手功能康复训练系统的分类、组成、技术要求、试验方法、检验规则、标志、包装、运输和贮存。

Brain computer interface and functional electrical stimulation rehabilitation system

T/CAAP 023-2022 上肢残肢的表面肌电信号采集与训练

规定了上肢截肢者的残肢表面肌电信号采集与训练的流程与安全性等。

Surface myoelectric signal acquiring and training processes for upper limb amputees

T/CAAP 024-2022 冷敷袋

规定了冷敷袋的技术要求、试验方法、检验规则、标志、标签、合格证、使用说明书、包装、运输、贮存。

Cold pack

BS EN ISO 20342-1:2022 躺下时保持组织完整性的辅助产品 一般要求

1   Scope 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 ...

Assistive products for tissue integrity when lying down - General requirements

EN ISO 20342-1:2022 躺下时组织完整性辅助产品.第1部分:一般要求

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.

Assistive products for tissue integrity when lying down - Part 1: General requirements (ISO 20342-1:2022)

PD CEN ISO/TS 20342-10:2022 躺下时保持组织完整性的辅助产品 聚氨酯 APTI 罩的清洁、消毒和护理指南

1   Scope This document provides guidance around best practices for cleaning, disinfecting and caring for the polyurethane covers for assistive products for tissue integrity when lying down ( APTIs ) where the covers are designed to protect the internal components of the APTI from damage. Adherence to this guidance will extend the operational life of the APTI and its tissue integrity performance. This document gives guidance for cleaning and disinfecting by manual means only. This document is not intended to give guidance related to the efficacy of the cleaning and disinfection procedures.

Assistive products for tissue integrity when lying down - Guide to cleaning, disinfecting and care of polyurethane APTI covers

BS EN ISO 21856:2022 辅助产品 一般要求和测试方法

1   Scope This document specifies general requirements and test methods for assistive products , considered to be medical devices , intended for use to alleviate or compensate for a disability . This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user . NOTE 1 Assistive products are considered to be medical devices in some jurisdictions but not in others. NOTE 2 Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33]. NOTE 3 Not all the items listed in ISO 9999 are medical devices . Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices .

Assistive products. General requirements and test methods

EN ISO 21856:2022 辅助产品.一般要求和试验方法

This document specifies general requirements and test methods for assistive products, considered to be medical devices, intended for use to alleviate or compensate for a disability. This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user. NOTE 1 Assistive products are considered to be medical devices in some jurisdictions but not in others. NOTE 2 Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33]. NOTE 3 Not all the items listed in ISO 9999 are medical devices. Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices.

Assistive products - General requirements and test methods (ISO 21856:2022)

ISO 20342-1:2022 躺下时组织完整性辅助产品.第1部分:一般要求

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 043306 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. 123103 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. 090706 Positioning pillows, positioning cushions and positioning systems such as but not limited to — leg positioners, 1 — arm positioners, and — multipurpose body positioners. 181215 Bedding such as but not limited to — draw sheets.

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

ISO 21856:2022 辅助产品.一般要求和试验方法

This document specifies general requirements and test methods for assistive products, considered to be medical devices, intended for use to alleviate or compensate for a disability. This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user. NOTE 1 Assistive products are considered to be medical devices in some jurisdictions but not in others. NOTE 2 Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33]. NOTE 3 Not all the items listed in ISO 9999 are medical devices. Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices.

Assistive products — General requirements and test methods

BS EN ISO 9999:2022 辅助产品 分类和术语

1   Scope This document specifies a classification and terminology of assistive products , especially produced or generally available, for persons to optimize functioning and reduce disability . Assistive products used by a person to optimize functioning and reduce disability , but which require the assistance of another person for their operation, are included in the classification. The following items are specifically excluded from this document: — items used for the installation of assistive products ; — solutions obtained by combinations of assistive products that are individually classified in this document; — medicines; — assistive products and instruments used exclusively by healthcare professionals or by teachers; — non-technical solutions, such as personal assistance, guide dogs or lip-reading; — implanted devices; — financia...

Assistive products. Classification and terminology

T/CASMES 48-2022 动态式马蹄足矫形器

本文件规定了动态式马蹄足矫形器的术语和定义、基本参数、技术要求、检验方法、检验规则、标签、标志、使用说明书、检验合格证、包装、运输和贮存。 本文件适用于动态式马蹄足矫形器（以下简称“矫形器”）。

Dynamic talipes equinus orthoses

EN ISO 9999:2022 残疾人辅助产品分类及术语

This document specifies a classification and terminology of assistive products, especially produced or generally available, for persons to optimize functioning and reduce disability. Assistive products used by a person to optimize functioning and reduce disability, but which require the assistance of another person for their operation, are included in the classification. The following items are specifically excluded from this document: — items used for the installation of assistive products; — solutions obtained by combinations of assistive products that are individually classified in this document; — medicines; — assistive products and instruments used exclusively by healthcare professionals or by teachers; — non-technical solutions, such as personal assistance, guide dogs or lip-reading; — implanted devices; — financial support.

Assistive products - Classification and terminology (ISO 9999:2022)