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Ti house-microport2013-12-13


微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
1. 技术要求和检验标准 Technical Specifications& Inspection Standards
序号 项目 No. Item 1 材料 material 接受标准 Acceptance Standard 纯钛,符合下面标准: ASTM-F67-06 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications, UNALLOY TITANIUM,MEET THE BELOW STANDARD: ASTM-F67-06 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.

IPG-MAT-001 钛壳 A/ Ti House A E.2.0394 XB 页码 Page Page 1 of 5

检测工具 Test Tool

检测方法 Test Method

抽样方案 Sampling 供方提供 Supplier confirmation

材质证明 Material Certification

2

表面状况 Surface condition

外表面光亮皮纹效果,等同封样,视觉情况下无裂纹、划伤无 放大 10 倍,视觉检查 Magnification of 10 明显毛刺、凹陷、凸起、油污、外来金属夹杂物等缺陷 The outside surface is bright dermatoglyph finished same as sealed times, visual Inspection sample, part surface shall be clean and without crack、scratch, without significant burrs、 dimple/pimple、 oil stain and foreign meta impurity & etc.

5 件,依据封样和照片进行判定 , 全部合格则接收否则不接收 5PCS , can accept only all are qualified.

3

平均晶粒度等级检测 The average grain size of the level detection 弯折部位厚度检查 Bend position thickness experiment 外表面粗糙度检查 Outside surface roughness inspection

ASTM_E112_2004 金属平均晶粒度测定标准-优于 A5 级 ASTM_E112_2004Standard Test Methods for Determining Average Grain Size1-better than class-A5 最小厚度≥0.2mm The minimum thickness ≥0.2mm 纵横向粗糙度≤0.8?m Both transverse and longitudinal roughness ≤0.8?m

材质证明 Certification of Material 尖头千分尺 Point micrometer 粗糙度测试仪 Roughness meter:

供方提供 Supplier confirmation 2 件,全部合格则接收否则不接收 2PCS , can accept only all ar e qualified. 5 件,全部合格则接收否则不接收 5PCS , can accept only all ar e qualified.

4

5

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
序号 项目 No. Item 6 接受标准 Acceptance Standard

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.
检测工具 Test Tool 检测工装 Inspection fixture 检测方法 Test Method

IPG-MAT-001 钛壳 A/ Ti House A E.2.0394 XB 页码 Page Page 2 of 5
抽样方案 Sampling Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

Weld band 内轮廓度检测 可以顺利插入检测工装 Weld band inside outlin can insert the inspection fixture smoothly inspection

7

Weld band 外轮廓度检测 可以顺利插入检测工装 Weld band outside outlin can insert the inspection fixture smoothly inspection

检测工装 Inspection fixture

Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
序号 项目 No. Item 8 平面度测量 flatness inspection 接受标准 Acceptance Standard

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.
检测工具 Test Tool 检测方法 Test Method

IPG-MAT-001 钛壳 A/ Ti House A E.2.0394 XB 页码 Page Page 3 of 5
抽样方案 Sampling

在 2kg 压力下基于多点 影测量

Smart scope base on these points use 2kg weight

△ △
9 9

投 Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

如图所示进行检测\ Inspecting according to the picture 9 长度和宽度 Length and width 高度测量 Heighness inspection 长度范围/Length =51.90±0.10mm 宽度范围/ Width = 30.70±0.10 mm 高度=3.00±0.10,如图进行检测。 Heighness=3.00±0.10 ,inspection according to the below picutre 15cm 数显卡尺 15cm digital calipers 数显千分尺 Digital microcalliper Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

10

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
序号 项目 No. Item 11 高度测量 Heighness inspection 接受标准 Acceptance Standard 高度=3.80±0.20,如图进行检测。 Heighness=3.80±0.20 ,inspection according to the below picutre

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.
检测工具 Test Tool 数显千分尺 Digital microcalliper 检测方法 Test Method

IPG-MAT-001 钛壳 A/ Ti House A E.2.0394 XB 页码 Page Page 4 of 5
抽样方案 Sampling Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

12

装配检查 Assemble inspection

装配后厚度/assemble whole heighness=6.5±0.1 装配后缝隙/gap≤0.127 mm

15cm 数显卡尺 15cm digital calipers

5件 5pcs

2. 出厂质量报告 Outgoing quality confirmation report
版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

未注单位/UNIT: mm

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
3. 4. 5. 6.

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.

IPG-MAT-001 钛壳 A/ Ti House A E.2.0394 XB 页码 Page Page 5 of 5

售后服务 After Service: No 备注 Remark: No 签字 Signature: No 注:纳入部品如不符合上述质量标准,纳入方可以要求退货。 Notes: In case the parts do not accord with the quality standard above, subscriber can request the rejection. 7. 供方确认 Confirmed by Supplier:

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
1. 技术要求和检验标准 Technical Specifications& Inspection Standards
序号 项目 No. Item 1 材料 material 接受标准 Acceptance Standard 纯钛,符合下面标准: ASTM-F67-06 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications, UNALLOY TITANIUM,MEET THE BELOW STANDARD: ASTM-F67-06 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications 2 表面状况 Surface condition

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.

XB

IPG-MAT-002 钛壳 B/ Ti House B E.2.0395 页码 Page Page 1 of 5

检测工具 Test Tool

检测方法 Test Method

抽样方案 Sampling 供方提供 Supplier confirmation

材质证明 Material Certification

外表面光亮皮纹效果,等同封样,视觉情况下无裂纹、划伤无 放大 10 倍,视觉检查 Magnification of 10 明显毛刺、凹陷、凸起、油污、外来金属夹杂物等缺陷 The outside surface is bright dermatoglyph finished same as sealed times, visual Inspection sample, part surface shall be clean and without crack、scratch, without significant burrs、 dimple/pimple、 oil stain and foreign meta impurity & etc. ASTM_E112_2004 金属平均晶粒度测定标准-优于 A5 级 ASTM_E112_2004Standard Test Methods for Determining Average Grain Size1-better than class-A5 最小厚度≥0.2mm The minimum thickness ≥0.2mm 纵横向粗糙度≤0.8?m Both transverse and longitudinal roughness ≤0.8?m 材质证明 Certification of Material 尖头千分尺 Point micrometer 粗糙度测试仪 Roughness meter:

5 件,全部合格则接收否则不接收 5PCS , can accept only all are qualified.

3

平均晶粒度等级检测 The average grain size of the level detection 弯折部位厚度检查 Bend position thickness experiment 外表面粗糙度检查 Outside surface roughness inspection

供方提供 Supplier confirmation 2 件,全部合格则接收否则不接收 2PCS , can accept only all ar e qualified. 5 件,全部合格则接收否则不接收 5PCS , can accept only all ar e qualified.

4

5

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
序号 项目 No. Item 6 接受标准 Acceptance Standard

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.
检测工具 Test Tool 检测工装 Inspection fixture 检测方法 Test Method

XB

IPG-MAT-002 钛壳 B/ Ti House B E.2.0395 页码 Page Page 2 of 5

抽样方案 Sampling Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

钛壳 B 内轮廓度检测 可以顺利插入检测工装,且 ?1.8 针规可顺利插入 4 个安装孔 Ti house B inside outlin can insert the inspection fixture smoothly, and ?1.8 pin gauge can inspection insert two part same as the below picture.

7

高度和平面度测量 如图所示进行检测\ Inspecting according to the below picture Heighness and flatnes inspection

在 2kg 压力下基于多点 影测量

Smart scope base on these points use 2kg weight

△ △
9 9

投 Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
序号 项目 No. Item 8 高度测量 Heighness inspection 接受标准 Acceptance Standard 高度=3.50±0.05,如图进行检测。 Heighness=3.50±0.05 ,inspection according to the below picutre

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.
检测工具 Test Tool 数显千分尺 Digital microcalliper 检测方法 Test Method

XB

IPG-MAT-002 钛壳 B/ Ti House B E.2.0395 页码 Page Page 3 of 5

抽样方案 Sampling Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

9

安装孔检测 Holes inspection

安装孔尺寸/hole’s diameter=?2±0.02

针规 Pin gauge

Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard
序号 项目 No. Item 10 长度和宽度 Length and width 毛刺检查 Burr inspection 接受标准 Acceptance Standard 长度范围/Length scope: 51.80~52.00 宽度范围/ Width scope: 30.60~30.80

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.
检测工具 Test Tool 15cm 数显卡尺 15cm digital calipers 检测方法 Test Method

XB

IPG-MAT-002 钛壳 B/ Ti House B E.2.0395 页码 Page Page 4 of 5

抽样方案 Sampling Inspect level :Ⅱ, AQL=1.5, double sampling plan according to ISO 2859-1:1999 5件 5pcs

11

毛刺大小≤0.05mm,毛刺方向符合下图。 人工 Burr of 0.05Max is allowed, and the burr direction according to th Manual inspection below picture

12

装配检查 Assemble inspection

装配后厚度/assemble whole heighness=6.5±0.1 装配后缝隙/gap≤0.127 mm

15cm 数显卡尺 15cm digital calipers

5件 5pcs

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.

微创医疗器械(上海)有限公司质量标准 MicroPort Medical (Shanghai) Co., Ltd. Quality Standard

文件编号 Document No. 物资名称 Part Name 物资编号 Part No. 版 本 Rev.

XB

IPG-MAT-002 钛壳 B/ Ti House B E.2.0395 页码 Page Page 5 of 5

2. 出厂质量报告 Outgoing quality confirmation report

未注单位\Unit:mm

售后服务 After Service: No 备注 Remark: No 签字 Signature: No 注:纳入部品如不符合上述质量标准,纳入方可以要求退货。 Notes: In case the parts do not accord with the quality standard above, subscriber can request the rejection. 7. 供方确认 Confirmed by Supplier: 3. 4. 5. 6.

版权所有,未经允许不得复制!No reproduction or networking, permitted without license from Microport.


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