Amy Wu

名词解释

背景

:::info

1. 每个项目开始的时候，SH文件服务器上会建立一个Released DHF Folder ，并按照项目阶段建立文件目录

   SVN服务器上会在DHF目录下按照固定的目录结构建立空目录
   该目录结构对应了DHF文件类型（“Type”）下文简称“Type目录”
   【固定目录结构可以查看 附录1 SVN-DHF-项目目录结构】
   项目经理 在Windows PC上利用TortoiseSVN 将SVN服务器上的该项目DHF目录 Checkout 到 本地SVN目录

SH文件服务器- Released DHF Folder 目录结构如下：

2. 在每个项目阶段中，项目成员将DHF文档更新至 SH文件服务器- Released DHF Folder 对应的项目阶段文件夹下默认规则如下：
1) 当前规范文件名定义： 14{device#}_DHF文档Type_Part.No_Revision.No.doc
2）文件类型包含 ： xlsx 、xls、doc 、 pdf、txt 。同名文件的pdf版本为doc或xls版本的签字扫描版本

1. 在项目阶段结束Tollgate时，项目经理PJM 会检查SH文件服务器-该阶段文件夹下的DHF文件，然后手动更新索引文件DHI文档【第一次创建该索引文件时，按照DHI模板创建，其余每次更新 Revision版本号加1】

   DHI文件需要进行Review，然后签字扫描成pdf格式,放在该阶段文件夹下<br />_DHI文件名定义_： 14{device#}_DHI_Part.No_Revision.No.xls<br />_DHI模板 介绍 ：_![图片.png](https://cdn.nlark.com/yuque/0/2021/png/22102453/1640851194230-e2345879-6154-4e74-b0b0-b074612b3327.png#clientId=u19289633-237f-4&crop=0&crop=0&crop=1&crop=1&from=paste&height=178&id=JiSjl&margin=%5Bobject%20Object%5D&name=%E5%9B%BE%E7%89%87.png&originHeight=356&originWidth=1830&originalType=binary&ratio=1&rotation=0&showTitle=false&size=46814&status=done&style=none&taskId=ub58c649d-2046-4bed-9af2-5b460248a41&title=&width=915)Type ——该DHF文件类型<br />Part ——该文件Part.No.<br />Revision —— 该文件Revision.No<br />Status  ——该文件状态<br />PS1-PS6 ——项目阶段TG1-TG6 ,表示该文件处于项目哪个阶段文件夹下

DHI文件内容如下

1. 在项目阶段结束Tollgate时，项目经理PJM 会手动将该阶段目录下的文件依次按照文件类型拷贝到本地SVN相应的目录下，拷贝完成以后，提交至SVN服务器。

2. TG6以后，产品认证工程师负责DHF文件更新，SVN服务器上的该项目DHF目录 Checkout 到 本地SVN目录，将新增的DHF文件按照文件类型放入“本地SVN-Type目录”下，将Type目录下的新增文档手动更新进DHI索引文件行。更新完成，Revision版本号升级，Review并且签字扫描放入SVN本地目录，提交到SVN服务器上。

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一、产品概述

1.版本信息

• 版本号：V0.1
• 创建日期：2021-12-29
• 审核人：

2.修订历史

4.产品介绍

4.1 产品名称

DHI Tool

4.2产品简介

每次SVN本地文件夹上的DHF文档有更新（文件名更新/新增文件），由DHI工具按照DHI模板自动填入更新文件明细，生成DHI修正版本，并将此版本提交到SVN服务器固定文件夹内

4.3用户画像

项目前期（TG1-TG6）： Project Manager 在每个Tollagate，都会将SH文件服务器上项目阶段里的DHF文档按照文档类型放入SVN本地文件夹中的相应Type目录下，每次更新生成相应的DHI文档
项目后期（TG6以后，DCR阶段）：产品认证工程师 ，管理已经转到德国SVN上的项目DHF文件，每次更新完成以后生成相应的DHI文档

4.4使用场景

三、功能详细说明

1.产品流程图

鼠标点击左上角，点击画板选择流程图，即可进入流程图创作你的产品流程图

2.功能说明

PC 端——Windows x64

四、非功能需求

可以列举性能需求、系统需求、运营需求、安全需求、财务需求、法务需求、统计需求、使用帮助等…

1. 性能需要

2. 统计需求

3. 使用帮助

五、埋点

九、项目规划

鼠标点击左上角，选择附件或者引入语雀内容，把正文提及的项目管理文档附在此处

附录

1. SVN-DHF-项目目录结构

:::info 卷 New Volume 的文件夹 PATH 列表
卷序列号为 1456-8F05
E:.
├─AIX - BSR (Beta Site)
│ ├─AIX - Assembly Instructions
│ ├─BDX - Baseline Definition
│ ├─BFX - BOM Freeze
│ ├─BSE - Beta Site Validation Environment Report
│ ├─BSL - Beta Site Validation Log
│ ├─BSP - Beta Site Validation Plan
│ └─BSR - Beta Site Validation Summary Report
├─CCB - CVX (Component)
│ ├─CCB - Meeting Minutes
│ ├─CDD - Component Design Documentation
│ ├─CE Dossier
│ │ ├─Chapter 01 - Product Family Description
│ │ │ └─PFD-Product Family Description
│ │ ├─Chapter 02 - Essential Requirements
│ │ │ ├─ERE - Essential Requiremnts RoHS
│ │ │ └─ERI - Esential Requiremnts IVD
│ │ ├─Chapter 03 - Declaration of Conformity
│ │ ├─Chapter 04 - Risk Analysis
│ │ │ ├─RAX - Risk Analysis
│ │ │ ├─RMP - Risk Management Plan
│ │ │ └─RMR - Risk Management Report
│ │ ├─Chapter 05 - List of harmonised standards
│ │ ├─Chapter 06 - Market monitoring
│ │ ├─Chapter 07 - Performance Evaluation Literature
│ │ ├─Chapter 08 - Instructions for Use
│ │ ├─Chapter 09 - Service Manual
│ │ ├─Chapter 10 - Product identification, labels, warning references at the product
│ │ ├─Chapter 11 - Validation of Packaging
│ │ ├─Chapter 12 - BOMs drawings, layouts, connection diagrams, data sheets
│ │ ├─Chapter 13 - Software documentation
│ │ ├─Chapter 14 - Product validation and verification (V&V report)
│ │ ├─Chapter 15 - Tests of Electrical safety
│ │ ├─Chapter 16 - Tests of Electromagnetic Compatibility (EMC)
│ │ ├─Chapter 17 - Additional test reports to demonstrate the compliance of applied standards
│ │ │ ├─Archive
│ │ │ └─Samplechecks
│ │ ├─Chapter 18 - Assembly Instructions
│ │ ├─Chapter 19 - Valididation of the Manufacturing Process
│ │ │ ├─PCP
│ │ │ └─PCR
│ │ └─Chapter 20 - Documentation of the Quality System
│ ├─CL1 - Component Test Log
│ ├─CLL-Country Launch List
│ ├─CPL - Critical Parts List
│ ├─CQR - Complaints and Quality Status Report
│ ├─CRP - additional Requirement Documents
│ ├─CRS - Component Requirements Specification
│ ├─CRX - Cable Drawing Review
│ ├─CTP - Customer Acceptance Test Plan
│ ├─CTR - Customer Acceptance Test Report
│ ├─CVE - Component Verification Environment Report
│ ├─CVL - Component Verification Log
│ ├─CVP - Component Verification Plan
│ ├─CVR - Component Verification Summary Report
│ ├─CVS - Component Verification Test Case Specification
│ └─CVX - Component Verification Execution Plan
├─DDP - LAR (Design)
│ ├─DDP - Design and Development Plan
│ ├─DFA - Design FMEA
│ ├─DFS - Design for Serviceability
│ ├─DHI - Design History File Index
│ ├─DMR - Device Master Record
│ ├─DRX - Design Review
│ ├─DTP - Design Transfer Plan
│ ├─DTR - Design Transfer Report
│ ├─ESD - Electrical Safety Document
│ ├─FII - Final Instrument Test Instruction
│ ├─FIR - Final Instrument Test Record
│ ├─FIV - Final Instrument Test Validation
│ ├─FPX - Feasibility Plan
│ ├─FRX - Feasibility Report
│ ├─FSR - Feasibility Summary Report
│ ├─GTM - Go to Market Plan
│ ├─IFU - Instructions for Use
│ ├─IPX - IP Review
│ ├─IRD - IFU Requirements Document
│ ├─LAR - Layout Review
│ └─LRI - ISO 15223-1 2016 Report
├─MAD - MVX (Module)
│ ├─MAD - Module Architecture Document
│ ├─MDD - Module Design Description
│ ├─MIR - Module Integration Reports
│ ├─MPP - Master Project Plan
│ ├─MRS - Module Requirements Specification
│ ├─MRX - Manufacture Data Review
│ ├─MTI - Module Test Instructions
│ ├─MTR - Module Test Records
│ ├─MVE - Module Verficatiion Environment Report
│ ├─MVL - Module Verification Log
│ ├─MVP - Module Verification Plan
│ ├─MVR - Module Verification Summary Report
│ ├─MVS - Module Verification Test Case Specifications
│ └─MVX - Module Verification Execution Plan
├─NAD - PVX (Product)
│ ├─NAD - Needs Assessment Document
│ ├─ODS - Open Design Change Summary
│ ├─OIS - Open Incidents Summary
│ ├─PAP-Leica Part Approval Process
│ ├─PAR - Prototype Assembly Review
│ ├─PCP - Process Validation Plan
│ ├─PCR - Process Validation Report
│ ├─PCX - Product Concept
│ ├─PDC - Production Process Concept
│ ├─PDX - Prototype Deviation
│ ├─PFA - Process FMEA
│ ├─PHR - Prototype History Report
│ ├─PLE - PLE-Deck
│ ├─PPC - Production Process
│ ├─PRC - Purchasing Process Concept
│ ├─PRD - Product Requirements Document
│ ├─PSR - Package Test
│ ├─PSV - Process Software Validation
│ ├─PTG - Histology Workflow
│ ├─PTP - Project Training Plan
│ ├─PVE - Product Validation Environment Report
│ ├─PVL - Product Validation Log
│ ├─PVP - Product Validation Plan
│ ├─PVR - Product Validation Summary Report
│ ├─PVS - Product Validation Test Case Specifications
│ └─PVX - Product Validation Execution Plan
├─QPX - SCX (Risk & Standard)
│ ├─QPX - Quality Plan
│ ├─RAX - Risk Analysis
│ ├─RCR - ROHS Compliance Report
│ ├─REP - En ISO 18113-3 IFU Review Report
│ ├─RGA - Risk and Gap Assessment
│ ├─RMP - Risk Management Plan
│ ├─RMR - Risk Management Report
│ ├─RSP - Regulatory Strategy Plan
│ ├─SAD - System Architecture Document
│ ├─SCE - Standard Compliance Verification Environment Report
│ ├─SCL - Standard Compliance Verification Log
│ ├─SCM - Software Configuration Management Plan
│ ├─SCP - Standard Compliance Verification Plan
│ ├─SCR - Standard Compliance Verification Summary Report
│ ├─SCS - Standard Compliance Verification Test Case Specifications
│ └─SCX - Standard Complinance Verification Execution Plan
├─SDD - SVX (System & Service)
│ ├─SDD - System Design Description
│ ├─SDP - Software Development Plan
│ ├─SIP - System Integration Plan
│ ├─SIR - System Integration Report
│ ├─SLP - System Labeling Plan
│ ├─SMX - Service Manual
│ ├─SPC - Service Process Concept
│ ├─SRN - Software Release Notes
│ ├─SRP - System Reliability Plan
│ ├─SRR - System Reliability Report
│ ├─SRS - System Requirements Specification
│ ├─SRX - Schematic Review
│ ├─SSR - Software Sprint Review Report
│ ├─SSS - Software Stub Requirements Specification
│ ├─SVA - Serviceability Readiness Summary
│ ├─SVC - Service Readiness Summary
│ ├─SVE - System Verification Environment Report
│ ├─SVL - System Verfication Log
│ ├─SVP - System Verification Plan
│ ├─SVR - System Verification Summary Report
│ ├─SVS - System Verification Test Case Specifications
│ └─SVX - System Verification Execution Plan
└─SWR - WTG (Tracing & Testware)
├─SWR - Software Code Review
│ ├─DCL
│ ├─Export
│ ├─GUI
│ ├─Kernel
│ ├─MSW
│ ├─REC
│ ├─S&M SW
│ ├─SKB
│ ├─Slave
│ └─SWU
├─TCM - Traceability Matrix
├─TDR - Technical Design Review
├─TGX - Tollgate Management Review
├─TIX - Test Instruction
├─TMA - Technical Maturity Assessment Report
├─TMP - Testware Master Plan
├─TRS - Testware Requirement Specifications
├─TVM - Testware Validation Master Plan
├─TVP - Testware Validation Plans
├─TVR - Testware Validation Reports
├─TVS - Testware Valildation Summary Report
├─TWM - Testware Verification Master Plan
├─TWP - Testware Verification Plans
├─TWR - Testware Verification Reports
├─TWS - Testware Verification Summary Report
├─UEC - Usability Engineering Checklist
├─UIS Stub Test Cases Specification
├─UTP - Usability Test Plan
├─UTR - Usability Test Report
├─VMP - Process Validation Plan
├─VOC - Voice of customers
├─VVP - Verification & Validation Plan
├─VVR - Verification & Validation Summary Report
└─WTG - _State Of The Art Technology

::: 输入 @ 把正文提及的具体文档，或需求相关的其他说明文档附在此处以供查阅

1. 数据分析报告
2. 用户调研报告
3. 设计分析报告
4. ……