机构名称辽宁省医疗器械检验检测院.DOC

1、ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 1 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

2、.机构名称：辽宁省医疗器械检验检测院注册号：L0201地 址：A：辽宁省沈阳市浑南生物医药产业园B：辽宁省沈阳市浑南高新技术产业开发区高荣路 5 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 2014 年 06 月 04 日2A授权签字人(英文) 复评+扩项 2014 年 06 月 04 日3 检测能力(中文) 复评+扩项 2014 年 06 月 04 日4A检测能力(英文) 复评+扩项 2014 年 06 月 04 日5 授权签字人(中文) 复评+扩项 2014 年 06 月 04 日6B授权签字人(英文) 复评+扩项 2

3、014 年 06 月 04 日7 检测能力(中文) 复评+扩项 2014 年 06 月 04 日8B检测能力(英文) 复评+扩项 2014 年 06 月 04 日ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 2 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 Englis

4、h version is provided by the conformity assessment body and is for reference only.Name：Liaoning Medical Device Test InstituteRegistration No.：L0201 ADDRESS：A: The District of Shenyang Hunnan Biomedical Industry Park, Shenyang, Liaoning, ChinaB：No.5, Gaorong Road, Hunnan Hi-Tech Development Zone, She

5、nyang, Liaoning, ChinaINDEX OF ACCREDITED SIGNATORIES No. Address Range Type Update date1 Approved signatories (Chinese)Reassessment+Extending assessment2014-06-042AApproved signatories (English)Reassessment+Extending assessment2014-06-043 Testing ability(Chinese)Reassessment+Extending assessment201

6、4-06-044ATesting ability(English)Reassessment+Extending assessment2014-06-045 Approved signatories (Chinese)Reassessment+Extending assessment2014-06-046BApproved signatories (English)Reassessment+Extending assessment2014-06-047 B Testing ability(Chinese)Reassessment+Extending assessment2014-06-04ISO

7、/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 3 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.No

8、. Address Range Type Update date8 Testing ability(English)Reassessment+Extending assessment2014-06-04ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 4 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevai

9、l in that the English version is provided by the conformity assessment body and is for reference only.中 国 合 格 评 定 国 家 认 可 委 员 会认 可 证 书 附 件（注册号：CNAS L0201）名称: 辽宁省医疗器械检验检测院 地址：辽宁省沈阳市浑南生物医药产业园签发日期：2014 年 06 月 04 日 有效期至：2017 年 06 月 03 日更新日期：2014 年 06 月 04 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 李宝良 EM

10、C 检测项目2 王建军 EMC 检测项目3 陈勇 EMC 检测项目4 郑国祥 EMC 检测项目5 柳晶波 EMC 检测项目6 王亚南 EMC 检测项目ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 5 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 vers

11、ion is provided by the conformity assessment body and is for reference only.CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENTAPPENDIX OF ACCREDITATION CERTIFICATE(Registration No. CNAS L0201) NAME:Liaoning Medical Device Test Institute ADDRESS:The District of Shenyang Hunnan Biomedical

12、Industry Park, Shenyang, Liaoning, China Date of Issue:2014-06-04 Date of Expiry:2017-06-03 Date of Update：2014-06-04APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE Name Authorized Scope of Signature Note1 Libaoliang EMC2 Wangjinjun EMC3 chenyong EMC4 Zhengguoxiang EMC5 liujingbo EMC6 wangyanan EMCISO/I

13、EC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 6 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.中 国

14、合 格 评 定 国 家 认 可 委 员 会认 可 证 书 附 件（注册号：CNAS L0201）名称: 辽宁省医疗器械检验检测院 地址：辽宁省沈阳市浑南生物医药产业园认可依据：ISO/IEC 17025:2005 以及 CNAS 特定认可要求签发日期：2014 年 06 月 04 日 有效期至：2017 年 06 月 03 日更新日期：2014 年 06 月 04 日附件 2 认可的检测能力范围项 目 /参 数序号检 测对 象 序 号 名 称领 域代 码检 测 标 准 （ 方 法 ） 名 称 及编 号 （ 含 年 号 ）限 制范 围 说 明1 全部参数 1205医用电气设备 第 1-2 部分：

15、安全通用要求 并列标准：电磁兼容 要求和试验YY0505-20121医疗电气设备（EMC）2 谐波电流 1205电磁兼容 限值 谐波电流发射限值（设备每相输入电流16A）GB/T17625.1-2012不测三相ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 7 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall pr

16、evail in that the English version is provided by the conformity assessment body and is for reference only.序号检 测对 象项 目 /参 数 领 域代 码检 测 标 准 （ 方 法 ） 名 称 及编 号 （ 含 年 号 ）限 制范 围 说 明序 号 名 称3电压波动和闪烁 1205电磁兼容 限值 对每相额定电流16A 且无条件接入的设备在公用低压供电系统中产生的电压变化、电压波动和闪烁的限制 GB 17625.2-2007不测三相4静电放电抗扰度 1205电磁兼容 试验和测量技术 静电放电抗

17、扰度试验GB/T17626.2-20065射频电磁场辐射抗扰度试验1205电磁兼容试验和测量技术 射频电磁场辐射抗扰度试验GB/T17626.3-20066电快速瞬变脉冲群抗扰度1205电磁兼容 试验和测量技术 电快速瞬变脉冲群抗扰度试验 GB/T17626.4-20087浪涌（冲击）抗扰度 1205电磁兼容 试验和测量技术 浪涌（冲击）抗扰度试验GB/T17626.5-20088RF 传导抗扰度 1205电磁兼容 试验和测量技术射频场感应的传导骚扰抗扰度抗扰度试验 GB/T17626.6-20089工频磁场抗扰度 1205电磁兼容 试验和测量技术 工频磁场抗扰度试验GB/T17626.8-2

18、0061医疗电气设备（EMC）10电压暂降、短时中断和电压变化抗扰度1205电磁兼容 试验和测量技术 电压暂降、短时中断和电压变化的抗扰度试验GB/T 17626.11-2008ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 8 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 th

19、e English version is provided by the conformity assessment body and is for reference only.序号检 测对 象项 目 /参 数 领 域代 码检 测 标 准 （ 方 法 ） 名 称 及编 号 （ 含 年 号 ）限 制范 围 说 明序 号 名 称2工业、科学和医疗（ISM）射频设备1 部分参数 1205工业、科学和医疗（ISM）射频设备电磁骚扰特性 限值和测量方法 GB 4824-2004不测 3G以上ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 9 页

20、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.CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASS

21、ESSMENTAPPENDIX OF ACCREDITATION CERTIFICATE(Registration No. CNAS L0201) NAME:Liaoning Medical Device Test Institute ADDRESS:The District of Shenyang Hunnan Biomedical Industry Park, Shenyang, Liaoning, China Accreditation Criteria:ISO/IEC 17025:2005 and relevant requirements of CNASDate of Issue:2

22、014-06-04 Date of Expiry:2017-06-03 Date of Update：2014-06-04APPENDIX 2 ACCREDITED TESTINGItem/Parameter Test Object Item/ ParameterCode of Field Title, Code of Standard or Method Limitation Note1Medical electrical equipment（EMC ）1 All items 1205Medical electrical equipment -Part 1-2: General requir

23、ements for safety -Collateral standard : Electromagnetic compatibility -Requirements and tests YY0505-2012ISO/IEC 17025 认可证书 CNAS-PD20/09-B/2No. CNAS L0201 第 10 页 共 63 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall

24、prevail in that the English version is provided by the conformity assessment body and is for reference only. Test ObjectItem/ParameterCode of Field Title, Code of Standard or Method Limitation Note Item/ Parameter2Harmonic current emissions1205Electromagnetic compatibility-Limits-Limits for harmonic

25、 current emissions (equipment input current 16A per phase)GB/T17625.1-2012Except for:Three phase1Medical electrical equipment（EMC ）3voltage fluctuations and flickers1205Electromagnetic compatibility （EMC）-Limits-Limitation of voltage change ,voltage fluctuations and flickers in public low-voltage supply systems ,for equipment with rated current 16A per phase and not subject to conditional connectionGB 17625.2-2007Except for:Three phase