EN 12182返回 Back
Test item 测试名称: 残疾人辅助器具 Technical aids for disabled persons
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Bath Stool/ Chair/Toilet Chair for EU Market (BS EN 12182) 欧盟市场洗澡椅/凳/便椅 |
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| Clause | Test Category试验类别 |
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EN 12182 Technical aids for disabled persons- General requirements and test methods 残疾人技术辅助设备一般要求和试验方法 |
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| 4 |
General Requirements 一般要求 |
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| 4.1 |
Risk Analysis 风险分析 |
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| 4.2 |
Intended performance and technical documentation 预期性能和技术文件 |
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| 4.3 |
Clinical evaluation 临床评价 |
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| 4.4 |
Aids that can be dismantled 可以拆卸的辅助设备 |
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| 4.5 |
Single use fasteners 一次性紧固件 |
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| 4.6 |
User mass limits 用户重量限制 |
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| 4.7 |
Immobilising means 固定手段 |
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| 4.8 |
Design requirements in relation to persons with cognitive impairment 认知障碍人士的设计要求 |
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| 5 |
Materials 材料 |
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| 5.2 | Flammability可燃性 |
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| 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 |
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| 5.4 |
Contaminants and residues (ISO 10993-1) 污染物及残余物(iso10993-1) |
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| 5.5 |
Infection and microbiological contamination 感染及微生物污染 |
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| 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 |
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| 6 |
Emitted sound and vibration 发出声音和振动 |
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| 7 |
Electromagnetic compatibility 电磁兼容性 |
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| 8 |
Electrical Safety 电气安全 |
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| 9.1 |
Overflow 溢出 |
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| 9.2 |
Spillage 溢出 |
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| 9.3 |
Leakage 渗漏 |
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| 9.4 |
Ingress of liquids 液体进入 |
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| 10 |
Surface temperature 表面温度 |
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| 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 |
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| 12 |
Safety of moving parts 活动部件的安全性 |
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| 13 |
Prevention of traps for parts of the human body 防止人体部分陷阱 |
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| 14 |
Folding and adjusting mechanisms 折叠和调节机构 |
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| 15 |
Carrying handles (if applicable) 搬运手柄(如适用) |
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| 16 |
Assistive products which support or suspend users 支持或暂停用户的辅助产品 |
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| 16.2 | Static forces静力 | ||||||||||||||
| 16.3 | Dynamic forces动力 | ||||||||||||||
| 16.4.2 |
Friction of tips ( ref. to ISO 24415 -1) 尖端摩擦力(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 |
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| 16.4.3 |
Durability of tips ( ref. to ISO 24415 -2) 贴士的耐用性(参考 iso24415-2) |
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| 18 |
Surfaces, corners and edges 表面，角落和边缘 |
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| 19 |
Hand held assistive products 手提式辅助产品 |
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| 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 |
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| 23 |
Ergonomic principles 人类工程学原理 |
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| 24 |
Requirements for information supplied by the manufacturer 制造商提供资料的规定 |
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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) |
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TAT: 15 working days: 15个工作天 |
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Others 其他:
Sample report 报告样本：
