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欧盟标准 EN 12182 欧盟市场洗澡椅/凳/便椅

Test item 测试名称: 残疾人辅助器具 Technical aids for disabled persons  
 


Bath Stool/ Chair/Toilet Chair for EU Market (BS EN 12182)
欧盟市场洗澡椅/凳/便椅
ClauseTest Category试验类别 
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
4General Requirements
一般要求

4.1Risk Analysis 
风险分析
4.2Intended performance and technical documentation 
预期性能和技术文件
4.3Clinical evaluation
临床评价
4.4Aids that can be dismantled
可以拆卸的辅助设备
4.5Single use fasteners
一次性紧固件
4.6User mass limits
用户重量限制
4.7Immobilising means
固定手段
4.8Design requirements in relation to persons with cognitive impairment
认知障碍人士的设计要求
5Materials 
材料
 
5.2Flammability可燃性
5.3Biocompatibility 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
5.4Contaminants and residues (ISO 10993-1)
污染物及残余物(iso10993-1)
5.5Infection and microbiological contamination
感染及微生物污染
5.6Resistance 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
6Emitted sound and vibration
发出声音和振动
7Electromagnetic compatibility
电磁兼容性
8Electrical Safety
电气安全
9.1Overflow 
溢出
9.2Spillage
溢出
9.3Leakage
渗漏
9.4Ingress of liquids
液体进入
10Surface temperature
表面温度
11Sterility 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
12Safety of moving parts
活动部件的安全性
13Prevention of traps for parts of the human body
防止人体部分陷阱
14Folding and adjusting mechanisms
折叠和调节机构
15Carrying handles (if applicable)
搬运手柄(如适用)
16Assistive products which support or suspend users
支持或暂停用户的辅助产品
16.2Static forces静力
16.3Dynamic forces动力
16.4.2Friction 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
16.4.3Durability of tips ( ref. to ISO 24415 -2)
贴士的耐用性(参考 iso24415-2)
18Surfaces, corners and edges
表面,角落和边缘
19Hand held assistive products
手提式辅助产品
20Small parts小零件
21Stability稳定性
22Forces in soft tissues of the human body
对人体软组织的作用力

risk analysis风险分析
23Ergonomic principles
人类工程学原理
24Requirements 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





Others 其他:


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