EN 12182标准残疾人辅助器具
发布：2022-11-27 14:34，更新：2024-04-28 10:30
| Bath Stool/ Chair/Toilet Chair for EU Market (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 disabled persons- 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 technical documentation 预期性能和技术文件 | |
| 4.3 | Clinical evaluation 临床评价 | |
| 4.4 | Aids that can be dismantled 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 to persons 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 (ISO 10993-1) 污染物及残余物(iso10993-1) | |
| 5.5 | Infection and microbiological contamination 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 vibration are not part of the intended performance of an assistive product（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 or electronic 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 insulation and live parts 适用于电气绝缘和带电部件 |
| 6 | Emitted sound and vibration 发出声音和振动 | |
| 7 | Electromagnetic compatibility 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 product is 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 the human body 防止人体部分陷阱 | |
| 14 | Folding and adjusting mechanisms 折叠和调节机构 | |
| 15 | Carrying handles (if applicable) 搬运手柄(如适用) | |
| 16 | Assistive products which support or suspend 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 assistive products 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 ISO 24415 -2) 贴士的耐用性(参考 iso24415-2) | |
| 18 | Surfaces, corners and edges 表面，角落和边缘 | |
| 19 | Hand held assistive products 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 human body 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 supplied by the manufacturer 制造商提供资料的规定 | |
| Sample size: 3 sets of completed products 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 working days: 15个工作天 | ||
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