医疗产品检验规范.pdf
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1、苏氏集团医疗产品外观检验规范 苏氏集团医疗产品外观检验规范 苏氏集团 Medical Product Cosmetic Specification Q-TD-80030 Parent: Q-MN-10000 ECO C- 1016679 Rev: A Owner: Quality Engineering Page: 1 of 35 This document contains proprietary information that may not be reproduced, transcribed or conveyed in any way or for any purpose with
2、out the prior written consent of Tyco Electronics. This Document is Electronically Controlled. Paper Copies are considered uncontrolled until revision has been confirmed. 目录 部分内容页码 1.0 目的 并共用非医疗产 品相关外观规范. 除 PHYSIO 产品外, 其他产品适用 IPC 620 CLASS II. SCOPE: Unless the customer has special requirements, thi
3、s specification applies to all medical products 苏氏集团 facility cosmetic inspection. This specification covers wire, label, and coated parts, molding cosmetic, crimping, welding and other manufacturing processes regulate the cosmetic of reference IPC 620; and related to the cosmetic of common norms of
4、 non-medical products. In addition to Physio products, other products for IPC 620 Class II. 2.0 职能和责任 FUNCTION Responsible for the development and maintenance of the specification 负责培训和指导相关人员本规范的要求 Responsible for the training and guidance to relevant personnel the requirements and specification com
5、pliance 依本规范不能作出准确判定或对本规范存有异议时,由 QC 人员提交至 QE 工程师级以上决定 Can not be accurately determined in accordance with these specifications, or there are objections to the specification, submitted by the QC staff to the above decision QE Engineer QC (IQC, IPQC, OQC) 监督本规范的要求在生产线或其它需依据本规范作业处的实施; Monitoring requir
6、ements of this specification required in the production lines or other operations in accordance with this specification at the implementation; 根据本规范及 AQL 抽样水准进行来料收货检验, 制程检验和产品出货检 验. AQL sampling in accordance with the norms and standards of the incoming, in-process and outgoing inspection. 生产部 Produ
7、ction Department 依据本规范进行产品生产,产品检验或产品返工 According to the specifications for manufacturing, product testing or product rework 3.0 文件 DOCUMENT 下阶文件 Responsible for the development and maintenance of the specification 负责培训和指导相关人员本规范的要求 Responsible for the training and guidance to relevant personnel the
8、requirements and specification compliance 依本规范不能作出准确判定或对本规范存有异议时,由QC 人员提交至 QE 工程师级以上决定 Can not be accurately determined in accordance with these specifications, or there are objections to the specification, submitted by the QC staff to the above decision QE Engineer QC (IQC, IPQC, OQC) 监督本规范的要求在生产线或
9、其它需依据本规范作业处的实 Non-uniform 覆盖不均匀 Nicks 刻痕 Pits 凹陷 Pinch 收缩 Porosity 有孔 Parting Line Flash 合模线毛边 Runs 滴状 Scratches 擦伤 Sinks 缩水 Speck 微粒 Short Shots 缺料 Streaking 条纹 Splay 张口 Weld Line 熔接线 Waviness 波纹 5.0 通用要求 GENERAL REQUIREMENTS 5.1. 在产品图纸上明确外观要求是产品开发的职责. 另外, 如图面有要求, 则图面要求优 先于本规范的要 求执行. Product develo
10、pment is responsible for stating the Cosmetic specification in product drawings. In addition, if drawings has clearly requirement, drawings requirements will be prioritized in the implementation of the specification requirements. 5.2. 任何图面可以以以下方式引用本规范作为外观标准. Any drawings can be requested in the foll
11、owing manner on the Cosmetic specification 5.2.1. 在图面上增加备注明确等级和相关适用附录. Note in the drawing for the product level and the applicable appendix A. 例如: 依据外观规范 Q-TD-80030 6.0 电缆外被外观评估规范等级 II. For example: Based on the Cosmetic specification Q-TD-80030 6.0 Cosmetic specification for Cable Jacket grade II.
12、 5.2.2. 用阴影和备注代号指定产品的特定区域. Mark with shadow and the notes on specific areas of the specified product code 5.2.3. 在图面备注上修订通用外观等级. Revised the grade of general cosmetic in the drawing note. A. 例如: 依据外观规范 Q-TD-80030 6 电缆外被外观评估规范等级 II 检验时间为 10 秒. For example: Based on the Cosmetic specification Q-TD-800
13、30 6.0 Cosmetic specification for Cable Jacket Grade II test for 10 seconds 苏氏集团医疗产品外观检验规范 苏氏集团 Medical Product Cosmetic Specification Q-TD-80030 Parent: Q-MN-10000 ECO C- 1016679 Rev: A Owner: Quality Engineering Page: 5 of 35 This document contains proprietary information that may not be reproduce
14、d, transcribed or conveyed in any way or for any purpose without the prior written consent of Tyco Electronics. This Document is Electronically Controlled. Paper Copies are considered uncontrolled until revision has been confirmed. 5.3. 在此外观标准前发行的图面不适用本规范. 如果要引用该规范, 需要通过 ECO/ECN 系统更新图面, 变更版本号. This
15、specification is not applied to the drawing released before this specification established. If there is a need to apply on this specification, ECO/ECN system update drawings changed the version number is required. 5.4. 外观类别: 产品等级与产品最终用途相关并为客户需要确定. Cosmetic Category: Product class and product-related
16、 and end-use customers as required 5.4.1. 一般客户及特殊客户中的 Covidien 外观等级如下: the general customers and specific customer Coviden cosmetic level as follow: A. 等级 I:外部终端客户可见或关键外观要求. Level I: external always seen by customer or critical cosmetic requirements. B. 等级 II:外部终端客户偶尔可见或中等外观要求. Level II: External us
17、ually seen by customer or middle level cosmetic requirements C. 等级 III:外部 终端客户不可见或非关键外观要求. Level III: External Never seen by customer or non critical cosmetic requirements 5.4.2. 特殊客户 Philips 外观标准的等级如下: Special customer Philips cosmetic levels are as follows: A. 等级 A: 经常可以被用户看到的表面 Level A: The surfa
18、ce is always seen by customer B. 等级 B: 很少被用户看到的面 Level B: The surface is rarely seen by customer 5.4.3. 特殊客户 Siemens 外观标准的等级划分请见 6.4 备注部分 Special Customer Siemens Cosmetic specification level Category will be referred to Notes section 6.4 5.5. 检验要求 Inspection Requirement 5.5.1. 目视条件: 产品必须在以下条件下检验: C
19、osmetic conditions: Product must be inspected under the following conditions: A. 足够, 均匀照明(80 到 50 foot candles) adequate, uniform illumination (80 to 50 foot candles) B. 确认表面瑕疵时不得处理零件 Surface defects shall not confirm the deal with spare parts C. 不得使用放大镜 No magnifying glass 5.6. 时间和距离: 时间和距离按附录定义执行,
20、 除非图面另有要求. Time and distance: time and distance, defined by the implementation of Appendix, unless otherwise requested drawings 5.7. 重复性的外观缺陷: 在同一位置重复发生的瑕疵容易发现. 如果开机时判定该瑕疵可 以接受, 则批次 验收时也可以接受. 6.9. Repetitive cosmetic of the defects: repeated in the same location easy to find. If defects been accepte
21、d at first time disposition, for subsequent Cosmetic inspection also considered as acceptable. 5.8. 参考尺寸: 缺陷大小尺寸仅供参考, 不做测量目的. Referenced Dimension: defect sizes are for reference only, not applied to measurement purposes. 苏氏集团医疗产品外观检验规范 苏氏集团 Medical Product Cosmetic Specification Q-TD-80030 Parent:
22、Q-MN-10000 ECO C- 1016679 Rev: A Owner: Quality Engineering Page: 6 of 35 This document contains proprietary information that may not be reproduced, transcribed or conveyed in any way or for any purpose without the prior written consent of Tyco Electronics. This Document is Electronically Controlled
23、. Paper Copies are considered uncontrolled until revision has been confirmed. 6.0 电缆外被外观评估规范 COSMETIC SPECIFICATION FOR CABLE JACKET TIME 时间: 5 秒. 适用于外观缺点和缺陷. Flaws/defects per Three Foot Section 每三英尺(90cm)长的 CABLE 瑕疵/缺 CLASS I ACCEPT LEVELS CLASS I 接收水平 CLASS II ACCEPT LEVELS CLASS II 接收水平 CLASS II
24、I ACCEPT LEVELS CLASS III 接收水平 Braid Impression 编织印痕 Slightly noticeable 轻微可见 Continuously visible picks but uniform 连续可见但分布均匀 Colored Spots 色斑 None 无 Two .02“ X .02“ Max. Diameter0.5 mm X 0.5 mm 两处. 直径 0.5 mm X 0.5 mm 最大 Convolutions 卷绕 Slightly Noticeable Convolutions 轻微可见卷曲 Noticeable Convoluted
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