Test item测试名称: 残疾人辅助器具 Technical aids for disabledpersons
Bath Stool/ Chair/Toilet Chair for EUMarket (BS EN 12182) 欧盟市场洗澡椅/凳/便椅 | ||
Clause | Test Category试验类别 | |
EN 12182 Technical aids for disabledpersons- General re and test methods 残疾人技术辅助设备一般要求和试验方法 | ||
4 | General Re 一般要求 | |
4.1 | Risk Analysis 风险分析 | |
4.2 | Intended performance and technicaldocumentation 预期性能和技术文件 | |
4.3 | Clinical evaluation 临床评价 | |
4.4 | Aids that can bedismantled 可以拆卸的辅助设备 | |
4.5 | Single use fasteners 一次性紧固件 | |
4.6 | User mass limits 用户重量限制 | |
4.7 | Immobilising means 固定手段 | |
4.8 | Design re in relation topersons with cognitive impairment 认知障碍人士的设计要求 | |
5 | Materials 材料 | |
5.2 | Flammability可燃性 | |
5.3 | Biocompatibility and Toxicity(ISO10993-5 & 10) 生物相容性及毒性(iso10993-5及10) | applicable for upholstered parts,mattress or bedding. 适用于软垫、床垫或床上用品 |
5.4 | Contaminants and residues (ISO10993-1) 污染物及残余物(iso10993-1) | |
5.5 | Infection and microbiologicalcontamination 感染及微生物污染 | |
5.6 | Resistance to corrosion (ISO 9227,168h) 耐腐蚀性(iso 9227,168h) | applicable for noise and vibrationare not part of the intended performance of an assistiveproduct(适用于噪音和振动不是辅助产品预期性能的一部分) applicable for electrical orelectronic devices/components (适用于电气绝缘和带电部件) applicable for electrical appliance(适用于电器 ) applicable for electrical insulationand live parts 适用于电气绝缘和带电部件 |
6 | Emitted sound andvibration 发出声音和振动 | |
7 | Electromagneticcompatibility 电磁兼容性 | |
8 | Electrical Safety 电气安全 | |
9.1 | Overflow 溢出 | |
9.2 | Spillage 溢出 | |
9.3 | Leakage 渗漏 | |
9.4 | Ingress of liquids 液体进入 | |
10 | Surface temperature 表面温度 | |
11 | Sterility 无菌测试 | applicable if the assistive productis intended to be sterilised 适用于拟进行消毒的辅助产品 |
12 | Safety of moving parts 活动部件的安全性 | |
13 | Prevention of traps for parts of thehuman body 防止人体部分陷阱 | |
14 | Folding and adjustingmechanisms 折叠和调节机构 | |
15 | Carrying handles (ifapplicable) 搬运手柄(如适用) | |
16 | Assistive products which support orsuspend users 支持或暂停用户的辅助产品 | |
16.2 | Static forces静力 | |
16.3 | Dynamic forces动力 | |
16.4.2 | Friction of tips ( ref. to ISO 24415-1) 摩擦力(参考 iso 24415-1) | applicable only if the assistiveproducts are provided with a tip 只适用于附有小费的辅助产品 |
16.4.3 | Durability of tips ( ref. to ISO24415 -2) 贴士的耐用性(参考 iso24415-2) | |
18 | Surfaces, corners andedges 表面,角落和边缘 | |
19 | Hand held assistiveproducts 手提式辅助产品 | |
20 | Small parts小零件 | |
21 | Stability稳定性 | |
22 | Forces in soft tissues of the humanbody 对人体软组织的作用力 | risk analysis风险分析 |
23 | Ergonomic principles 人类工程学原理 | |
24 | Re for information suppliedby the manufacturer 制造商提供资料的规定 | |
Sample size: 3 sets of completedproducts with all the packaging material/instruction 样本量:3套成品及所有包装物料/说明书(物料除外) | ||
TAT: 15 workingdays: 15个工作天 |
Others 其他:
Samplereport 报告样本: