机构名称：国家康复辅具研究中心康复辅具质量监督检验中心

机构名称：国家康复辅具研究中心康复辅具质量监督检验中心 ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 机构名称:国家康复辅具研究中心康复辅具质量监督检验中心 注册号:L2073 地 址: A:北京市经济技术开发区荣华中路1号 获准认可能力索引 序号 地址 能力范围 评审类型 更新时间 1 授权签字人(中文) 复评+扩项 2013年02月16日 2 授权签字人(英文) 复评+扩项 2013年02月16日 A 3 授权签字人(中文) 监督+扩项 2014年06月23日 4 授权签字人(英文) 监督+扩项 2014年06月23日 5 检测能力(中文) 复评+扩项 2013年02月16日 6 检测能力(英文) 复评+扩项 2013年02月16日 A 7 检测能力(中文) 监督+扩项 2014年06月23日 8 检测能力(英文) 监督+扩项 2014年06月23日 No. CNAS L2073 第 1 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Name:Rehabilitation Technical Aids Quality Supervision & Test Center, National Research Center for Rehabilitation Technical Aids Registration No.:L2073 ADDRESS: A: No.1, Ronghua Middle Road, Beijing Economic & Technological Development Zone, China INDEX OF ACCREDITED SIGNATORIES No. Address Range Type Update date Reassessment+ 1 Approved signatories (Chinese) Extending 2013-02-16 assessment Reassessment+ 2 Approved signatories (English) Extending 2013-02-16 assessment A Surveillance+E 3 Approved signatories (Chinese) xtending 2014-06-23 assessment Surveillance+E 4 Approved signatories (English) xtending 2014-06-23 assessment Reassessment+ 5 Testing ability(Chinese) Extending 2013-02-16 assessment Reassessment+ 6 Testing ability(English) Extending 2013-02-16 assessment A Surveillance+E 7 Testing ability(Chinese) xtending 2014-06-23 assessment Surveillance+E 8 Testing ability(English) xtending 2014-06-23 assessment No. CNAS L2073 第 2 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 No. CNAS L2073 第 3 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L2073) 名称: 国家康复辅具研究中心康复辅具质量监督检验中心 地址:北京市经济技术开发区荣华中路1号 签发日期:2013年02月16日 有效期至:2016年02月15日 更新日期:2013年02月16日 附件1 认可的授权签字人及领域 序号 姓 名 授权签字领域 备 注 1 闫和平 全部检测项目 2 谷慧茹 全部检测项目 No. CNAS L2073 第 4 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L2073) NAME:Rehabilitation Technical Aids Quality Supervision & Test Center, National Research Center for Rehabilitation Technical Aids ADDRESS: No.1, Ronghua Middle Road, Beijing Economic & Technological Development Zone, China Date of Issue:2013-02-16 Date of Expiry:2016-02-15 Date of Update:2013-02-16 APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE ? Name Authorized Scope of Signature Note 1 Yan Heping Authorized all field of the laboratory 2 Gu Huiru Authorized all field of the laboratory No. CNAS L2073 第 5 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L2073) 名称: 国家康复辅具研究中心康复辅具质量监督检验中心 地址:北京市经济技术开发区荣华中路1号 认可依据:ISO/IEC 17025:2005以及CNAS特定认可要求 签发日期:2013年02月16日 有效期至:2016年02月15日 更新日期:2013年02月16日 附件2 认可的检测能力范围 项目/参数 序检测 领域 检测()名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 MZ001-1993 电动上肢假肢 不测 电动上臂假 1 1 *部分参数 0719 GB/T 18027-2008电动上肢假噪声 肢 肢部件 MZ001-1993 电动上肢假肢 不测 电动前臂假 2 1 *部分参数 0719 GB/T 18027-2008 噪声 肢 电动上肢假肢部件 MZ001-1993 电动上肢假肢 不测 3 电动假手 1 *部分参数 0719 GB/T 18027-2008 噪声 电动上肢假肢部件 No. CNAS L2073 第 6 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 MZ001-1993 电动上肢假肢 不测 4 电动肘关节 1 *部分参数 0719 GB/T 18027-2008 噪声 电动上肢假肢部件 自身力源上MZ002-1993 5 1 *全部参数 0719 臂假肢 自身力源上肢假肢 自身力源前MZ002-1993 6 1 *全部参数 0719 臂假肢 自身力源上肢假肢 MZ002-1993 7 机械假手 1 *全部参数 0719 自身力源上肢假肢 MZ002-1993 8 机械肘关节 1 *全部参数 0719 自身力源上肢假肢 GB14722-2008 组件式髋大 9 1 *全部参数 0719 组件式髋部、膝部和大腿假 腿假肢 肢 GB14722-2008 组件式大腿 10 1 *全部参数 0719 组件式髋部、膝部和大腿假 假肢 肢 GB14722-2008 组件式膝大 11 1 *全部参数 0719 组件式髋部、膝部和大腿假 腿假肢 肢 组件式小腿GB/T13461-2008 12 1 *全部参数 0719 假肢 组件式小腿假肢 No. CNAS L2073 第 7 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB14723-2008 下肢假肢通用件 GB/T18375.1-2001 ISO 10328-1:1996 假肢 下 肢假肢的结构检验 第1部 分:试验配置 GB/T18375.2-2001 ISO 10328-2:1996 假肢 下肢假肢的结构检验 第2部分:试验样品 13 假肢髋关节 1 *全部参数 0719 GB/T18375.3-2001 ISO 10328-3:1996假肢 下肢 假肢的结构检验 第3部分: 主结构检验 GB/T18375.4-2001 ISO 10328-4:1996假肢 下肢 假肢的结构检验 第4部分: 主结构检验中的加载参数 No. CNAS L2073 第 8 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB/T18375.5-2004 ISO 10328-5:1996 假肢 下肢假肢的结构检验 第5部分:辅助结构检验 GB/T18375.6-2004 ISO 10328-6:1996假肢 下肢 假肢的结构检验 第6部分: 辅助结构检验中的加载参数 GB/T18375.7-2004 13 假肢髋关节 1 *全部参数 0719 ISO 10328-7:1996 假肢 下肢假肢的结构检验 第7部分:试验成交文件 GB/T18375.8-2004 ISO 10328-8:1996假肢 下肢 假肢的结构检验 第8部分: 检验 No. CNAS L2073 第 9 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB14723-2008 下肢假肢通用件 GB/T18375.1-2001 ISO 10328-1:1996 假肢 下 肢假肢的结构检验 第1部 分:试验配置 GB/T18375.2-2001 ISO 10328-2:1996 假肢 下肢假肢的结构检验 14 假肢膝关节 1 *全部参数 0719 第2部分:试验样品 GB/T18375.3-2001 ISO 10328-3:1996假肢 下肢 假肢的结构检验 第3部分: 主结构检验 GB/T18375.4-2001 ISO 10328-4:1996假肢 下肢 假肢的结构检验 第4部分: 主结构检验中的加载参数 No. CNAS L2073 第 10 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB/T18375.5-2004 ISO 10328-5:1996 假肢 下肢假肢的结构检验 第5部分:辅助结构检验 GB/T18375.6-2004 ISO 10328-6:1996假肢 下肢 假肢的结构检验 第6部分: 辅助结构检验中的加载参数 14 假肢膝关节 1 *全部参数 0719 GB/T18375.7-2004 ISO 10328-7:1996 假肢 下肢假肢的结构检验 第7部分:试验成交文件 GB/T18375.8-2004 ISO 10328-8:1996假肢 下肢 假肢的结构检验 第8部分: 检验报告 No. CNAS L2073 第 11 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB14723-2008 下肢假肢通用件 GB/T18375.1-2001 ISO 10328-1:1996 假肢 下 肢假肢的结构检验 第1部 分:试验配置 GB/T18375.2-2001 ISO 10328-2:1996 假肢 下肢假肢的结构检验 15 假肢踝关节 1 *全部参数 0719 第2部分:试验样品 GB/T18375.3-2001 ISO 10328-3:1996假肢 下肢 假肢的结构检验 第3部分: 主结构检验 GB/T18375.4-2001 ISO 10328-4:1996假肢 下肢 假肢的结构检验 第4部分: 主结构检验中的加载参数 No. CNAS L2073 第 12 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB/T18375.5-2004 ISO 10328-5:1996 假肢 下肢假肢的结构检验 第5部分:辅助结构检验 GB/T18375.6-2004 ISO 10328-6:1996假肢 下肢 假肢的结构检验 第6部分: 辅助结构检验中的加载参数 15 假肢踝关节 1 *全部参数 0719 GB/T18375.7-2004 ISO 10328-7:1996 假肢 下肢假肢的结构检验 第7部分:试验成交文件 GB/T18375.8-2004 ISO 10328-8:1996假肢 下肢 假肢的结构检验 第8部分: 检验报告 No. CNAS L2073 第 13 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB14723-2008 下肢假肢通用件 GB/T18375.1-2001 ISO 10328-1:1996 假肢 下 肢假肢的结构检验 第1部 分:试验配置 GB/T18375.2-2001 ISO 10328-2:1996 假肢 下肢假肢的结构检验 16 假脚 1 *全部参数 0719 第2部分:试验样品 GB/T18375.3-2001 ISO 10328-3:1996假肢 下肢 假肢的结构检验 第3部分: 主结构检验 GB/T18375.4-2001 ISO 10328-4:1996假肢 下肢 假肢的结构检验 第4部分: 主结构检验中的加载参数 No. CNAS L2073 第 14 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB/T18375.4-2001 ISO 10328-4:1996假肢 下肢 假肢的结构检验 第4部分: 主结构检验中的加载参数 GB/T18375.5-2004 ISO 10328-5:1996 假肢 下肢假肢的结构检验 第5部分:辅助结构检验 GB/T18375.6-2004 ISO 10328-6:1996假肢 下肢16 假脚 1 *全部参数 0719 假肢的结构检验 第6部分: 辅助结构检验中的加载参数 GB/T18375.7-2004 ISO 10328-7:1996 假肢 下肢假肢的结构检验 第7部分:试验成交文件 GB/T18375.8-2004 ISO 10328-8:1996假肢 下肢 假肢的结构检验 第8部分: 检验报告 不测X支条式脊柱MZ004-1993 17 1 *部分参数 0719 线 矫形器 支条式脊柱矫形器 摄影 不测X支条式下肢MZ003-1993 18 1 *部分参数 0719 线 矫形器 支条式下肢矫形器 摄影 手动三轮轮GB/T13800-2009 19 1 *全部参数 17 椅车 手动轮椅车 手动四轮轮GB/T13800-2009 20 1 *全部参数 17 椅车 手动轮椅车 道路型电动GB/T 12996-1991 21 1 *全部参数 17 轮椅车 电动轮椅车 No. CNAS L2073 第 15 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 室内型电动GB/T 12996-1991 22 1 *全部参数 17 轮椅车 电动轮椅车 室外型电动GB/T 12996-1991 23 1 *全部参数 17 轮椅车 电动轮椅车 GB/T14728.1-2006 ISO11199-1:1999 双臂操 24 框式助行架 1 *全部参数 17 作助行器要求和试验方法第 1部分:框式助行架 GB/T14728.2-2008 ISO11199-2:2005双臂操作 25 轮式助行架 1 *全部参数 17 助行器具要求和实验方法第 2部分:轮式助行架 GB/T 14728.3-2008 ISO 11199-3:2005双臂操作 26 台式助行架 1 *全部参数 17 助行器具要求和实验方法第 3部分:台式助行器 GB/T 19545.2-2009 单臂操 27 腋拐 1 *全部参数 17 作助行器要求和试验方法 第2部分:腋拐 GB/T 19545.2-2009 单臂操 28 腋拐支脚垫 1 *全部参数 17 作助行器要求和试验方法 第2部分:腋拐 GB/T 19545.1 –2004 ISO 11334-1:1994 29 肘拐杖 1 *全部参数 17 单臂操作助行器技术要求和 试验方法 第1部分:肘拐杖 GB/T 22752-2008 30 抓握杆 1 *全部参数 17 残疾人辅助器具 抓握杆 No. CNAS L2073 第 16 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB/T 19545.4-2008 ISO 11334-4:1999 三脚或多脚 31 1 *全部参数 17 单臂操作助行器具 要求和手杖 试验方法 第4部分:三脚或 多脚手杖 GB/T 16930.1-1997 不测安 盲人手杖 安全色标志 32 普通盲杖 1 *部分参数 17 全色 GB/T 16930.2-2009 盲杖 技术条件 GB/T 20403—2006 普通固定式 33 1 *全部参数 17 普通固定式康复训练床 康复训练床 不测电YY 0571-2005 磁兼容，IEC 60601-2-38:1996 34 医用电动床 1 *部分参数 0433 不测AP医用电气设备 第2部分:医 型和APG院电动床安全专用要求 型设备 *单一故障 1 状态 *控制器命 2 令信号处理ISO7176-14:2008 故障 电动轮椅车电动轮椅车动力和控制系统 35 17 *控制器输控制系统 -要求和测试方法 3 出装置故障 *断电时的 4 停车能力 5 *通/断开关 *电源接通 6 时控制信号 No. CNAS L2073 第 17 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 *控制器过 7 电压保护 8 *显示装置 *充电时抑 9 制行驶 ISO7176-14:2008 10 *电绝缘 电动轮椅车动力和控制系统 -要求和测试方法 *非绝缘部电动轮椅车11 35 17 件的保护 控制系统 *堵转状态12 保护 13 *操作力 *控制装置14 耐用性 15 *电器连接 GB/T 18029.9-2008 16 *环境 ISO 7176.9:2009 电动轮椅车的气候试验方法 GB/T 18029.1-2008 *静态稳定 1 ISO 7176.1:1999静态稳定性性 的测定 GB/T 18029.2-2009 *动态稳定 2 ISO 7176.2:2001电动轮椅车性 36 轮椅车 17 动态稳定性的测定 GB/T 18029.3-2008 3 *制动器 ISO 7176.3:2003制动器的测 定 GB/T 18029.4-2009 4 *能耗 ISO 7176.4:2008能耗的测定 No. CNAS L2073 第 18 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 *外形尺寸、GB/T 18029.5-2008 5 质量和转向ISO 7176.5:2008外形尺寸、 空间 质量和转向空间的测定 GB/T 18029.6-2009 *最大速度、 ISO 7176.6:2001 6 加速度和减 电动轮椅车最大速度、加速 速度 度和减速度的测定 36 轮椅车 17 GB/T 18029.7-2009 *座位和车 7 ISO 7176.7:1998座位和车轮轮尺寸 尺寸的测量方法 GB/T 18029.8-2008 *静态强度, ISO 7176.8:1998静态强度、 8 冲击强度及 冲击强度及疲劳强度的要求 疲劳强度 和测试方法 GB/T 18029.9-2008 9 *气候试验 ISO 7176.9:2009电动轮椅车 的气候试验方法 GB/T 18029.10-2009 10 *越障 ISO 7176.10:2008电动轮椅 不测电车越障能力的测定 36 轮椅车 17 ISO 7176.14:2008 磁兼容 *动力和控 11 电动轮椅车动力和控制系统 制系统 -要求和测试方法 GB/T 18029-2000 *座靠垫阻ISO 7176.16:1997轮椅车 座 12 燃性 (靠)垫阻燃性的要求和测 试方法 不测电 磁兼容， 医用电气设GB 9706.1-2007医用电气设 37 1 *部分参数 4 不测AP 备 备 第1部分:安全通用要求, 型和APG 型设备 No. CNAS L2073 第 19 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 EN 12183:2009 手动轮椅车 38 手动轮椅车 1 **全部参数 17 要求和测试方法 EN 12184:2009 电动轮椅车、不测 39 电动轮椅车 1 **部分参数 17 代步车及其充电器的要求和电磁兼 测试方法 容 GB/T 24434-2009 座便椅 40 座便椅(凳) 1 **全部参数 17 (凳) 可调式康复GB/T 26340-2010 可调式康 41 1 **全部参数 17 训练床 复训练床 股四头肌训GB/T 26346-2010 康复训练 42 1 **全部参数 17 练椅 器械 股四头肌训练椅 康复训练器GB 24436-2009 康复训练器 43 1 **全部参数 17 械 械 安全通用要求 不测材 GB/T 26339-2010 眼科光学料，不测44 电子助视器 1 **部分参数 17 与设备 电子助视器 电磁兼 容 GB/T 17257.2-2009 集尿袋 45 集尿袋 1 **全部参数 17 第2部分:要求和检验方法 GB/T 20407.2-2006 造口袋 第2部分:要求和测试方法 46 造口袋 1 **全部参数 17 GB/T 20407.3-2006 造口袋 第3部分:结肠造口袋和回 肠造口袋气味弥散测定 No. CNAS L2073 第 20 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 GB/T 14199-2010 电声学 助 听器通用规范 GB/T 25102.100-2010 电 声学 助听器 第0部分:电 声特性的测量 不测电 GB/T 25102.1-2010 电声磁兼容， 学 助听器 第1部分:具有 47 助听器 1 **部分参数 14 不测骨 感应拾音线圈输入的助听器 导式助 GB/T 25102.2-2010 电声听器 学 助听器 第2部分:具有 自动增益控制电路的助听器 GB/T 25102.4-2010 电声 学 助听器 第4部分:助听 器用感应回路系统磁场强度 GB/T 20404-2006 残疾人运 残疾人运送 48 1 **全部参数 17 送用升降架 技术要求和试 用升降架 验方法 **升降平台 1 的一般要求 沿斜面运行 **导轨和机JG/T 318-2011 沿斜面运 49 无障碍升降2 17 械制动装置 行无障碍升降平台技术要求 平台 **安全装置 3 和限速器 No. CNAS L2073 第 21 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 只测一 般要求、 制动系 统、紧急 或手动沿斜面运行操纵、齿 **传动单元JG/T 318-2011 沿斜面运 49 无障碍升降4 17 条和齿 和传动系统 行无障碍升降平台技术要求 平台 轮驱动 的补充 要求和 悬链驱 动的补 充要求 No. CNAS L2073 第 22 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 只测一 般要求、 爬电距 离、电气 间隙和 外壳防 护、电气 安全装 置、延 时、驱动 **电气设备电动机 5 及安装一般 的保护、 要求 电气配 线、安全 沿斜面运行电路、漏JG/T 318-2011 沿斜面运 49 无障碍升降17 电保护行无障碍升降平台技术要求 平台 装置、终 端限制 开关和 终端安 全开关、 紧急报 警装置 6 **运载装置 **测试、检7 查及维修 8 **技术文件 **标签、注 9 意事项及操 作说明 No. CNAS L2073 第 23 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 Q/XH 1-2012步行辅助车(老 50 老人车 1 **全部参数 17 人车) 51 洗浴椅 1 **全部参数 17 Q/XH 3-2012 浴室用椅子 No. CNAS L2073 第 24 页 共 63 页 The scope of the accreditation in Chinese remains the definitive version. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L2073) NAME:Rehabilitation Technical Aids Quality Supervision & Test Center, National Research Center for Rehabilitation Technical Aids ADDRESS: No.1, Ronghua Middle Road, Beijing Economic & Technological Development Zone, China Accreditation Criteria:ISO/IEC 17025:2005 and relevant requirements of CNAS Date of Issue:2013-02-16 Date of Expiry:2016-02-15 Date of Update:2013-02-16 APPENDIX 2 ACCREDITED TESTING Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter MZ001-1993 electric Electric arm *Partial Except for 1 above-elbow-prost1 0719 GB/T 18027-2008 Items noise hesis Components of electric upper limb MZ001-1993 electric Electric arm *Partial Except for 2 below-elbow 1 0719 GB/T 18027-2008 Items noise prosthesis Components of electric upper limb No. CNAS L2073 第 25 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter MZ001-1993 Electric arm *Partial GB/T 18027-2008 Except for 3 electric hand 1 0719 Items Components of noise electric upper limb MZ001-1993 Electric arm *Partial GB/T 18027-2008 Except for 4 electric elbow unit 1 0719 Items noise Components of electric upper limb MZ002-1993 body-powered body-powered upper 5 above-elbow 1 *All Items 0719 limb prosthesis prosthesis MZ002-1993 body-powered body-powered upper 6 below-elbow 1 *All Items 0719 limb prosthesis prosthesis MZ002-1993 body-powered upper 7 mechanical hand 1 *All Items 0719 limb prosthesis MZ002-1993 mechanical elbow body-powered upper 8 1 *All Items 0719 unit limb prosthesis No. CNAS L2073 第 26 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB14722-2008 modular hip disarticulation endoskeletal hip prosthesis, Modular 9 above-knee 1 *All Items 0719 knee disarticulation prosthesis prosthesis and modular above knee prosthesis GB14722-2008 modular hip disarticulation endoskeletal prosthesis, Modular 10 above-knee 1 *All Items 0719 knee disarticulation prosthesis prosthesis and modular above knee prosthesis GB14722-2008 modular hip disarticulation endoskeletal knee prosthesis, Modular 11 above-knee 1 *All Items 0719 knee disarticulation prosthesis prosthesis and modular above knee prosthesis GB/T13461-2008 synthetic resin modular below knee 12 below-knee 1 *All Items 0719 prosthesis prosthesis No. CNAS L2073 第 27 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB14723-2008 Modular units of the lower limb prosthesis GB/T 18375.1-2001ISO 10328-1:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 1:Test configurations GB/T 18375.2-2001ISO 13 hip unit 1 *All Items 0719 10328-2:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 2:Test samples GB/T 18375.3-2001ISO 10328-3:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 3:Principle structural tests No. CNAS L2073 第 28 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18375.4-2001ISO 10328-4:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 4:Loading parameters of principal structural tests GB/T 18375.5-2004ISO 10328-5:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 5:Supplementary structural tests GB/T 18375.6-2004ISO 10328-6:1996 Prosthetics_Structural testing of 13 hip unit 1 *All Items 0719 lower-limb prostheses-Part 6:Loading parameters of supplementary structural tests GB/T 18375.7-2004ISO 10328-7:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 7:Test submission document GB/T 18375.8-2004ISO 10328-8:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 8:Test report No. CNAS L2073 第 29 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB14723-2008 Modular units of the lower limb prosthesis GB/T 18375.1-2001ISO 10328-1:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 1:Test configurations GB/T 18375.2-2001ISO 14 knee unit 1 *All Items 0719 10328-2:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 2:Test samples GB/T 18375.3-2001ISO 10328-3:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 3:Principle structural tests No. CNAS L2073 第 30 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18375.4-2001ISO 10328-4:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 4:Loading parameters of principal structural tests GB/T 18375.5-2004ISO 10328-5:1996 Prosthetics_Structur 14 knee unit 1 *All Items 0719 al testing of lower-limb prostheses-Part 5:Supplementary structural tests GB/T 18375.6-2004ISO 10328-6:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 6:Loading parameters of supplementary structural tests No. CNAS L2073 第 31 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18375.7-2004ISO 10328-7:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 7:Test submission 14 knee unit 1 *All Items 0719 document GB/T 18375.8-2004ISO 10328-8:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 8:Test report No. CNAS L2073 第 32 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB14723-2008 Modular units of the lower limb prosthesis GB/T 18375.1-2001ISO 10328-1:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 1:Test configurations GB/T 18375.2-2001ISO 10328-2:1996 15 ankle unit 1 *All Items 0719 Prosthetics_Structur al testing of lower-limb prostheses-Part 2:Test samples GB/T 18375.3-2001ISO 10328-3:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 3:Principle structural tests GB/T 18375.4-2001ISO 10328-4:1996 No. CNAS L2073 第 33 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Prosthetics_Structural testing of lower-limb prostheses-Part 4:Loading parameters of principal structural tests GB/T 18375.5-2004ISO 10328-5:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 5:Supplementary structural tests GB/T 18375.6-2004ISO 15 ankle unit 1 *All Items 0719 10328-6:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 6:Loading parameters of supplementary structural testsGB/T 18375.7-2004ISO 10328-7:1996 Prosthetics_Structural testing of lower-limb prostheses-Part 7:Test submission document No. CNAS L2073 第 34 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18375.8-2004ISO 10328-8:1996 Prosthetics_Structur15 ankle unit 1 *All Items 0719 al testing of lower-limb prostheses-Part 8:Test report No. CNAS L2073 第 35 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB14723-2008 Modular units of the lower limb prosthesis GB/T 18375.1-2001ISO 10328-1:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 1:Test configurations GB/T 18375.2-2001ISO 16 prosthetic feet 1 *All Items 0719 10328-2:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 2:Test samples GB/T 18375.3-2001ISO 10328-3:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 3:Principle structural tests No. CNAS L2073 第 36 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18375.4-2001ISO 10328-4:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 4:Loading parameters of principal structural 16 prosthetic feet 1 *All Items 0719 tests GB/T 18375.5-2004ISO 10328-5:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 5:Supplementary structural tests No. CNAS L2073 第 37 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18375.6-2004ISO 10328-6:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 6:Loading parameters of supplementary structural testsGB/T 18375.7-2004ISO 10328-7:1996 16 prosthetic feet 1 *All Items 0719 Prosthetics_Structur al testing of lower-limb prostheses-Part 7:Test submission document GB/T 18375.8-2004ISO 10328-8:1996 Prosthetics_Structur al testing of lower-limb prostheses-Part 8:Test report MZ004-1993 upright spine *Part of Spinal orthosis with Except for 17 1 0719 orthosis Items uprights X-rays No. CNAS L2073 第 38 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter MZ003-1993 upright lower limb *Part of lower limb orthosis Except for 18 1 0719 orthosis Items with uprights X-rays GB/T13800-2009 manual tri-wheel 19 1 *All Items 17 Manual wheelchairs wheelchair manual GB/T13800-2009 20 quadri-wheel 1 *All Items 17 Manual wheelchairs wheelchair GB/T 12996-1991 electric wheelchair 21 1 *All Items 17 electric wheelchairs for road GB/T 12996-1991 electric wheelchair 22 1 *All Items 17 electric wheelchairs for indoor GB/T 12996-1991 electric wheelchair 23 1 *All Items 17 electric wheelchairs for outdoor GB/T14728.1-2006 ISO11199-1:1999 Walking aids Walking manipulated by both 24 frames 1 *All Items 17 arms requirements and test methods-Part1:Walk ing frames No. CNAS L2073 第 39 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T14728.2-2008 ISO11199-2:2005 Walking aids manipulated by both 25 Rollators 1 *All Items 17 arms requirements and test methods-Part2: Rollators GB/T14728.3-2008 ISO11199-3:2005 Walking aids manipulated by both 26 Walking tables 1 *All Items 17 arms requirements and test methods-Part3: Walking tables GB/T 19545.2-2009 General axillary 27 Axillary crutch 1 *All Items 17 crutch GB/T 19545.2-2009 Axillary crutch General axillary 28 1 *All Items 17 tips crutch No. CNAS L2073 第 40 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 19545.1 –2004 ISO 11334-1:1994 Walking aids manipulated by one 29 Elbow crutches 1 *All Items 17 arm requirements and test methods- Part 1:Elbow crutches GB/T 22752-2008 Technical aids for persons with 30 Grab-rails 1 *All Items 17 disabilities-Grab-rail s GB/T 19545.4-2008 ISO 11334-4:1999 Walking aids manipulated by one Walking sticks arm –Requirements 31 with three or more 1 *All Items 17 and test legs methods-Part 4:Walking sticks with three or more legs GB/T 16930.1-1997 Except for Tactile sticks-A Tactile *Partial safety 32 1 17 sign of safety sticks Items colours colours No. CNAS L2073 第 41 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 16930.2-2009 Tactile sticks-Technical specification Rigid GB/T 20403-2006 33 rehabilitation 1 *All Items 17 Rigid rehabilitation training bed training bed YY 0571-2005 IEC 60601-2-38:1996 Except for Medical electrical EMC，AP Electrically equipment - Part 2: *Partial 34 Operated Hospital 1 0433 Particular equipment Items Beds requirements for the and APG safety of electrically equipment operated hospital beds ISO 7176-14 Power *Single and control systems 1 fault for electrically conditions powered Wheelchairs wheelchairs and 35 17 -control systems scooters –requirements and test methods *Controller command 2 signal processing failure No. CNAS L2073 第 42 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter *Controller output 3 device failure *Ability to stop when 4 power is removed *On/off 5 switch ISO 7176-14 Power and control systems for electrically powered *Control Wheelchairs wheelchairs and 35 6 signal at 17 -control systems scooters switch on –requirements and test methods ISO 7176-14 Power and control systems for electrically *Controller powered 7 over-voltage Wheelchairs wheelchairs and protection 35 17 -control systems scooters –requirements and test methods *Measuring 8 devices No. CNAS L2073 第 43 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter *Drive inhibit 9 during charging *Electrical 10 isolation *Protection from 11 non-insulate d electrical parts *Stalled 12 condition protection *Operating 13 forces *Control 14 devices durability *Electrical 15 connections GB/T 18029.9-2008 ISO 7176.9:2009 Wheelchairs *environmeWheelchairs - Part 35 16 17 -control systems ntal 9: Climatic tests for electric wheelchairs No. CNAS L2073 第 44 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18029.1-2008 ISO 7176.1:1999 *Static Wheelchairs - Part 1 stability 1: Determination of static stability GB/T 18029.2-2009 ISO 7176.2:2001 Wheelchairs - Part Wheel *Dynamic 36 2 17 2: Determination of chair stability dynamic stability of electric wheelchairs GB/T 18029.3-2008 ISO 7176.3:2003 Wheelchairs - Part 3 *Brakes 3: Determination of effectiveness of brakes No. CNAS L2073 第 45 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18029.4-2009 ISO 7176.4:2008 Wheelchairs - Part 4: Energy *Energy consumption of Wheel 36 4 consumptio17 electric wheelchairs chair n and scooters of determination of theoretical distance rang GB/T 18029.5-2008 ISO 7176.5:2008 *Overall Wheelchairs - Part dimensions, 5: Determination of 5 mass and overall dimension, turning mass and turning space space Wheel 36 GB/T 18029.6-2009 chair ISO 7176.6:2001 Wheelchairs - Part *seating and 6: Determination of 6 wheel maximum dimensions speed,acceleration and deceleration of electric wheelchairs No. CNAS L2073 第 46 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 18029.7-2009 ISO 7176.7:1998 *seating and Wheelchairs - Part 7 wheel 7:Measurement of dimensions seating and wheel dimensions GB/T 18029.8-2008 ISO 7176.8:1998 *static, Wheelchairs - Part Wheel impact and 8: Requirements and 36 8 chair fatigue test methods for strengths static, impact and fatigue strengths GB/T 18029.9-2008 ISO 7176.9:2009 *Climatic Wheelchairs - Part 9 tests 9: Climatic tests for electric wheelchairs GB/T Wheel Except for 18029.10-2009 36 17 chair EMC ISO 7176.10:2008 Wheelchairs-Part10 *Obstacle-c10 :Determination of limbing obstacle-climbing ability of electric wheelchair No. CNAS L2073 第 47 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter ISO 7176.14:2008 Wheelchairs-Part14 :power and control systems for *Power and electrically powered 11 control wheelchairs and systems scooters- Requirement and test methods GB/T 18029-2000 *Resistance ISO 7176.16:1997 to ignition Wheelchairs--ResistWheel Except for 36 12 of 17 ance to ignition of chair EMC upholstered upholstered parts parts--Requirements and test methods GB 9706.1-2007 Except for Medical electrical EMC，AP Safety test for *Partial equipment—Part 37 medical electrical 1 4 equipment Items 1:General equipment and APG requirements for equipment safety EN 12183:2009 Manual Manual wheelchairs 38 1 **All Items 17 wheelchairs - Requirements and test methods No. CNAS L2073 第 48 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter EN 12184:2009 electrically powered electrically wheelchairs, **Part of Except 39 powered 1 17 scooters and their Items for EMC wheelchairs chargers - requirements and test methods GB/T 24434-2009 40 Commode chairs 1 **All Items 17 Commode chairs GB/T 26340-2010 Adjustable Adjustable 41 rehabilitation 1 **All Items 17 rehabilitation training bed training bed GB/T 26346-2010 Rehabilitation Quadriceps 42 1 **All Items 17 training training chair instrument—Quadri ceps training chair GB 24436-2009 Rehabilitation Rehabilitation 43 1 **All Items 17 training training instrument instrument—Genera l safety requirements GB/T 26339-2010 Ophthalmic optics Electro-optical and Except for devices for **Partial 44 1 17 instruments—Electrmaterial and enhancing low Items o-optical devices for EMC vision enhancing low vision No. CNAS L2073 第 49 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 17257.2-2009 Urine collection Urine collection 45 1 **All Items 17 bags—Part bags 2:Requirements and test methods GB/T 20407.2-2006 Ostomy collection bags―Part 2: Requirements and test methods Ostomy collection GB/T 20407.3-2006 46 1 **All Items 17 bags Ostomy collection bags―Part 3: Determination of odour transmission of colostomy and ileostomy bags No. CNAS L2073 第 50 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 14199-2010 Electroacoustics—G eneral specification for hearing aids GB/T 25102.100-2010 Electroacoustics—H earing aids—Part 0:Measurement of electroacoustical characteriistics GB/T 25102.1-2010 Electroacoustics—H earing aids—Part Except 1:Hearing aids with for EMC **Part of induction pick-up 47 Hearing aids 1 14 and Items coil input bone-conduct GB/T 25102.2-2010 hearing aid Electroacoustics—H earing aids—Part 2:Hearing aids with automatic gain control circuits GB/T 25102.4-2010 Electroacoustics—H earing aids—Part 4:Induction loop systems for hearing aid purposes—Magnetic field strength No. CNAS L2073 第 51 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter GB/T 25102.100-2010 Electroacoustics—H earing aids—Part 0:Measurement of electroacoustical characteriistics GB/T 25102.1-2010 Electroacoustics—H earing aids—Part 1:Hearing aids with induction pick-up Except coil input for EMC **Part of GB/T 25102.2-2010 47 Hearing aids 1 14 and Items Electroacoustics—Hbone-conduct earing aids—Part hearing aid 2:Hearing aids with automatic gain control circuits GB/T 25102.4-2010 Electroacoustics—H earing aids—Part 4:Induction loop systems for hearing aid purposes—Magnetic field strength GB/T 20404-2006 Hoists for the Hoists for the transfer of disabled 48 transfer of disabled 1 **All Items 17 persons―Requirempersons ents and test methods No. CNAS L2073 第 52 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter **General requirement1 s for stairlifts **Guide rails and 2 mechanical stops **Safety JG/T 318-2011 gear and Technique 3 Barrier free overspeed requirements for power-operated governor barrier free 49 lifting platforms 17 Accreditedonlpower-operated for moving in an y for general lifting platforms for inclined plane requirements, moving in an braking inclined plane system, emergency/m anual **Driving operation, units and 4 additional drive requirements system for rack and pinion drive, additional requirements for chain suspension drive. No. CNAS L2073 第 53 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Accreditedonl y for general, creepage and clearance distances and enclosure requirements, electric safety devices, time delay, protection of the driving **Electrical motor, installation JG/T 318-2011 5 electrical and Technique wiring, safety Barrier free equipment requirements for circuits, power-operated barrier free residual 49 lifting platforms 17 power-operated current for moving in an lifting platforms for devices, inclined plane moving in an terminal limit inclined plane switches and final limit safety switches, emergency alarm devices. 6 **Carriage **Testing,in 7 spection and servicing **Technical 8 literature No. CNAS L2073 第 54 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter JG/T 318-2011 Technique Barrier free **Labels,norequirements for power-operated tices and barrier free 49 lifting platforms 9 17 operating power-operated for moving in an instructions lifting platforms for inclined plane moving in an inclined plane Q/XH 1-2012 50 Walking Trolley 1 **All Items 17 Walking Trolley Q/XH 3-2012Bath 51 Bath chair 1 **All Items 17 chair No. CNAS L2073 第 55 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L2073) 名称: 国家康复辅具研究中心康复辅具质量监督检验中心 地址:北京市经济技术开发区荣华中路1号 签发日期:2013年02月16日 有效期至:2016年02月15日 更新日期:2014年06月23日 附件1 认可的授权签字人及领域 序号 姓 名 授权签字领域 备 注 1 闫和平 全部检测项目 2 谷慧茹 全部检测项目 No. CNAS L2073 第 56 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L2073) NAME:Rehabilitation Technical Aids Quality Supervision & Test Center, National Research Center for Rehabilitation Technical Aids ADDRESS:No.1, Ronghua Middle Road, Beijing Economic & Technological Development Zone, Beijing, China Date of Issue:2013-02-16 Date of Expiry:2016-02-15 Date of Update:2014-06-23 APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE ? Name Authorized Scope of Signature Note 1 Yan Heping All accredited testing items 2 Gu Huiru All accredited testing items No. CNAS L2073 第 57 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L2073) 名称:国家康复辅具研究中心康复辅具质量监督检验中心 地址:北京市经济技术开发区荣华中路1号 认可依据:ISO/IEC 17025:2005以及CNAS特定认可要求 签发日期:2013年02月16日 有效期至:2016年02月15日 更新日期:2014年06月23日 附件2 认可的检测能力范围 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 1 电动牵引床 1 **全部参数 0433 电动牵引床YY 0697-2008 假肢和矫形器 要求和试验 2 上肢假肢 1 **全部参数 0719 方法ISO 22523-2006 假肢 踝足装置和足部组件 3 假脚 1 **全部参数 0719 要求和试验方法ISO 22675-2006 假肢 踝足装置和足部组件 4 踝关节 1 **全部参数 0719 要求和试验方法ISO 22675-2006 No. CNAS L2073 第 58 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 不测运 医用电气设 医用电器环境要求及试验方输试验、5 备(环境试1 **部分参数 0433 法GB/T 14710-2009 不测碰 验) 撞试验 下肢矫形器假肢和矫形器 要求和试验 6 1 **全部参数 0719 膝铰链 方法ISO 22523-2006 无创自动测无创自动测量血压计YY 7 1 **全部参数 0433 量血压计 0670-2008 不测防电动轮椅车 电动轮椅车用永磁直流齿轮尘测试、用永磁直流 8 1 **部分参数 17 减速电动机构通用技术条件 不测水齿轮减速电 GB/T 29634-2013 平冲击动机 试验 不测生减重步行训减重步行训练台 YY 9 1 **部分参数 0433 物相容练台 0900-2013 性 10医用电气设备 第2部分:医(院电动床安全专用要求YY 医用电动床 1 **全部参数 0433 原0571-2013 34) IEC 60601-2-38:1996 No. CNAS L2073 第 59 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L2073) NAME:Rehabilitation Technical Aids Quality Supervision & Test Center, National Research Center for Rehabilitation Technical Aids ADDRESS:No.1, Ronghua Middle Road, Beijing Economic & Technological Development Zone, Beijing, China Accreditation Criteria:ISO/IEC 17025:2005 and relevant requirements of CNAS Date of Issue:2013-02-16 Date of Expiry:2016-02-15 Date of Update:2014-06-23 APPENDIX 2 ACCREDITED TESTING Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Dynamoelectric dynamoelectric **All 1 1 0433 traction-table YY traction-table Parameters 0697-2008 External limb prostheses and external limb **All external 2 1 0719 prostheses Parameters orthoses-Requireme nts and test methods ISO 22523-2006 No. CNAS L2073 第 60 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Prosthetics-Testing of ankle-foot **All devices and foot 3 prosthetic feet 1 0719 Parameters units-Requirements and test methods ISO 22675-2006 Prosthetics-Testing of ankle-foot **All devices and foot 4 ankle-foot devices 1 0719 Parameters units-Requirements and test methods ISO 22675-2006 Environmental medical electrical Except for requirement and test equipmenttransport test、**Part of menthods for 5 1 0433 (environmental Parameters medical electrical Except for equipment requirement) impact test GB/T 14710-2009 External limb prostheses and knee external jointassemblies for **All orthoses — 6 1 0719 lower-limb Parameters Requirements and orthotic devices test methods ISO 22523-2006 noninvasive Noninvasive automatic blood automatic blood **All 7 pressure 1 0433 pressure monitoring Parameters monitoring equipment YY equipment 0670-2008 No. CNAS L2073 第 61 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter General permanent specification for Except for magnetic DC permanent magnetic dust proof **Part of 8 gearmotor using 1 17 DC gearmotor using Parameters test、the level on electric on electric of impact test wheelchairs wheelchairs GB/T 29634-2013 Walk training walk training Except for **Part of platform with 9 platform with 1 0433 biocompatibil Parameters suspension YY suspension ity 0900-2013 Medical electrical equipment - Part 2: Particular requirements for the 10Electrically **All safety of electrically (3Operated Hospital 1 0433 Parameters operated hospital Beds 4) beds YY 0571-2013 IEC 60601-2-38:1996 No. CNAS L2073 第 62 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 No. CNAS L2073 第 63 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.