IEC
62304

Reference

Software Lifecycle
Process

Applicable
for

Class

A

Class

B

Class

C

　

PRIMARY
LIFECYCLE PROCESESS

　

　

　

5

SOFTWARE
DEVELOPMENT Process

　

　

　

5.1

Development Planning
Activity

　

　

　

5.1.1

Software
development plan task

X

X

X

5.1.2

Software
development plan reference to SYSTEM requirements task

X

X

X

5.1.3

SOUP management
planning task

　

X

X

5.1.4

Software
development measures planning task

　

X

X

5.1.5

Software
integration and integration testing planning task

　

X

X

5.1.6

Software
VERIFICATION planning task

X

X

X

5.1.7

Software
VERIFICATION requirements coverage planning task

　

X

X

5.1.8

Software RISK
MANAGEMENT planning task

X

X

X

5.1.9

Documentation
planning task

X

X

X

5.1.10

Software
configuration management planning task

X

X

X

5.1.11

Software
configuration control planning task

　

X

X

5.1.12

Software problem
resolution planning task

　

　

X

5.2

Requirements Analysis
Activity

　

　

　

5.2.1

Define software
requirements from SYSTEM requirements task

X

X

X

5.2.2

Establish
software requirements task

X

X

X

5.2.3

Software
requirements content task

X

X

X

5.2.4

Include RISK
CONTROL measures in software requirements task

　

X

X

5.2.5

Update RISK
ANALYSIS task

X

X

X

5.2.6

Ensure
compliance with SYSTEM requirements task

X

X

X

5.2.7

Uniquely
identify software requirements task

X

X

X

5.2.8

Update SYSTEM
requirements task

X

X

X

5.2.9

Verify software
requirements task

X

X

X

5.2.10

Document
software requirements VERIFICATION task

X

X

X

5.3

Architectural Design
Activity

　

　

　

5.3.1

Transform
software requirements into an ARCHITECTURE task

X

X

X

5.3.2

Document
software ARCHITECTURE task

X

X

X

5.3.3

Document
software safety classification of each SOFTWARE ITEM
task

X

X

X

5.3.4

Develop an
ARCHITECTURE for the interfaces of SOFTWARE ITEMS task

　

X

X

5.3.5

Specify SYSTEM
hardware and software required by SOUP item task

　

X

X

5.3.6

Specify
functional and performance requirements of SOUP item
task

　

X

X

5.3.7

Identify
segregation necessary for SAFETY task

　

X

X

5.3.8

Verify software
ARCHITECTURE task

　

X

X

5.3.9

Verify
appropriateness of software development plan task

　

X

X

5.3.10

Document results
of software ARCHITECTURE VERIFICATION task

　

X

X

5.4

Detailed
Design Activity

　

　

　

5.4.1

Refine SOFTWARE
ITEMS into SOFTWARE UNITS task

　

X

X

5.4.2

Inheritance of
software safety classification task

　

X

X

5.4.3

Develop detailed
design for each SOFTWARE UNIT task

　

　

X

5.4.4

Develop detailed
design for interfaces task

　

　

X

5.4.5

Verify detailed
design task

　

X

X

5.4.6

Additional
detailed design VERIFICATION task

　

　

X

5.4.7

Document results
of design VERIFICATION task

　

X

X

5.5

Software
Coding Activity

　

　

　

5.5.1

Implement each
SOFTWARE UNIT task

　

X

X

5.5.2

Establish
SOFTWARE UNIT VERIFICATION PROCESS task

　

X

X

5.5.3

Verify software
code task

　

X

X

5.5.4

Additional
software code VERIFICATION task

　

X

X

5.5.5

Document the
results of software code VERIFICATION task

　

X

X

5.6

Integration and Testing
Activity

　

　

　

5.6.1

Integrate
SOFTWARE UNITS task

　

X

X

5.6.2

Verify software
integration task

　

X

X

5.6.3

Document the
results of software integration task

　

X

X

5.5.4

Additional
software code VERIFICATION task

　

X

X

5.6.5

Integration
testing content task

　

X

X

5.6.6

Include
integration testing for non-normal cases task

　

　

X

5.6.7

Conduct
regression tests task

　

X

X

5.6.8

Document results
of software integration tests task

　

X

X

5.6.9

Integration test
documentation contents task

　

X

X

5.6.10

Use formal
software problem resolution PROCESS task

　

X

X

5.7

System
Testing Activity

　

　

　

5.7.1

Establish tests
for each software requirement task

　

X

X

5.7.2

Use formal
software problem resolution PROCESS task

　

X

X

5.7.3

Repeat tests and
conduct regression tests task

　

X

X

5.7.4

Verify SOFTWARE
SYSTEM testing task

　

X

X

5.7.5

Record data for
each test task

　

X

X

5.8

Release
Activity

　

　

　

5.8.1

Ensure software
VERIFICATION is complete

　

X

X

5.8.2

Ensure
documentation is complete

　

X

X

5.8.3

Document known
residual anomalies

　

X

X

5.8.4

Evaluate known
residual anomalies

　

X

X

5.8.5

Document
released VERSIONS

　

X

X

5.8.6

Document how
released software was created

　

X

X

5.8.7

Archive master
copies

　

X

X

5.8.8

Use established
procedures for software release

　

X

X

6

SOFTWARE
MAINTENANCE Process

　

　

　

6.1

Establish software
maintenance plan Activity

　

　

　

6.1.1

Establish
software maintenance plan task

X

X

X

6.2

Problem
and Modification Analysis Activity

　

　

　

6.2.1

Record and
evaluate feedback task

X

X

X

6.2.2

Use software
problem resolution PROCESS task

X

X

X

6.2.3

Analyse
modification requests task

X

X

X

6.2.4

Conduct analysis
of changes implied by modification request task

X

X

X

6.2.5

Document new,
modified and deleted item task

X

X

X

6.2.6

Review and
approve modification task

X

X

X

6.2.7

Document
modification task

　

X

X

6.3

Modification
Implementation Activity

　

　

　

6.3.1

Use established
PROCESS to implement modification task

X

X

X

6.3.2

Define criteria
for testing modifications task

　

X

X

6.3.3

Verify
modifications task

　

X

X

6.3.4

Conduct
regression testing task

　

X

X

6.3.5

Demonstrate
software RISK CONTROL measures remain effective task

　

X

X

6.3.6

Document the
test results task

　

X

X

see
5.3

Architectural Design
Activity

　

　

　

see
5.4

Detailed
Design Activity

　

　

　

see
5.5

Software
Coding Activity

　

　

　

see
5.6

Integration and Testing
Activity

　

　

　

see
5.7

System
Testing Activity

　

　

　

see
5.8

Release
Activity

　

　

　

　

SUPPORTING
PROCESSES

　

　

　

7

SOFTWARE
RISK MANAGEMENT Process (referenced ISO 14971)

　

　

　

7.1

Analysis
of software contributing to HAZARDS Activity

　

　

　

7.1.1

Identify
SOFTWARE ITEMS that could contribute to a HAZARD task

　

X

X

7.1.2

Identify
potential causes of contribution to a HAZARD task

　

X

X

7.1.3

Consider
specific potential causes task

　

X

X

7.1.4

Review published
SOUP anomaly lists task

　

X

X

7.1.5

Document
potential causes task

　

X

X

7.1.6

Document
sequences of events task

　

X

X

7.2

RISK
CONTROL measures Activity

　

　

　

7.2.1

Define RISK
CONTROL measures task

　

X

X

7.2.2

RISK CONTROL
measures implemented in software task

　

X

X

7.3

VERIFICATION of RISK
CONTROL measures Activity

　

　

　

7.3.1

Verify RISK
CONTROL measures task

　

X

X

7.3.2

Document any new
sequences of events task

　

X

X

7.3.3

Document
TRACEABILITY task

　

X

X

7.4

RISK
MANAGEMENT of software changes Activity

　

　

　

7.4.1

Analyse changes
TO MEDICAL DEVICE SOFTWARE with respect to safety task

X

X

X

7.4.2

Analyse impact
software changes on existing RISK CONTROL measures task

　

X

X

7.4.3

Perform RISK
MANAGEMENT ACTIVITIES based on analyses task

　

X

X

8

SOFTWARE
CONFIGURATION MANAGEMENT Process

　

　

　

8.1

Configuration
identification Activity

　

　

　

8.1.1

Establish means
to identify CONFIGURATION ITEMS task

X

X

X

8.1.2

Identify SOUP
task

X

X

X

8.1.3

Document SOUP
designator task

X

X

X

8.1.4

Identify SYSTEM
configuration documentation task

X

X

X

8.2

Configuration control
Activity

　

　

　

8.2.1

Identify and
record change requests task

X

X

X

8.2.2

Approve requests
prior to implementation task

X

X

X

8.2.3

Implement
changes task

X

X

X

8.2.4

Provide means
for TRACEABILITY of change task

X

X

X

8.3

Configuration status
accounting Activity

　

　

　

8.3.1

Configuration
status accounting task

X

X

X

9

SOFTWARE
PROBLEM RESOLUTION Process

　

　

　

　

SOFTWARE
PROBLEM RESOLUTION Activity

　

　

　

9.1.1

Prepare problem
reports task

X

X

X

9.1.2

Advise relevant
parties task

X

X

X

9.1.3

Investigate the
problem task

X

X

X

9.1.4

Evaluate the
problem's relevance to safety task

X

X

X

9.1.5

Track and report
status task

X

X

X

9.1.6

Resolve the
problem task

X

X

X

9.1.7

Maintain a
record of the problem task

X

X

X

9.1.8

Analyse problems
for trends task

X

X

X

9.1.9

Verify
task

X

X

X

IEC_62304_CheckList的更多相关文章

随机推荐

  1. AI简单平移追踪算法

    1.比较坐标追踪法 追踪者会不停地比较自身和目标的x坐标和y坐标,每x和y上一个单位的移动为一个周期,该算法虽然简单好用,但实用性差且不智能化,如果追踪者数量增加,路线会显得单调,由于都是先走个对角线 ...

  2. MySQL Migration Tool报“initialized java loader”错误的问题

    MySQL Migration Tool报“initialized java loader”错误的问题   运行MySQL Migration Tool时经常会提示“An error occured ...

  3. nginx图片处理笔记（http-image-filter-module、lua）

    实验环境:CentOS 6.10 目标:1.使用http-image-filter-module进行图片变换:2.使用lua进行格式转换: 安装EPEL https://fedoraproject.o ...

  4. Java二进制兼容性原理

    一.概述 现在的软件越来越依赖于不同厂商.作者开发的共享组件,组件管理也变得越来越重要.在这方面,一个极其重要的问题是类的不同版本的二进制兼容性,即一个类改变时,新版的类是否可以直接替换原来的类,却不 ...

  5. log4php0.9的详细配备实例说明

    一.什么是log4php: log4j在JAVA中可算是大名鼎鼎的日志开发包了,它为apche组织维护项目,VxR兄使用php来实现了log4j的功能, 目前log4php已经作为log4j的一个子项 ...

  6. IOS项目之弹出动画二

    在IOS项目之弹出动画一中只是实现也功能,并没有体现面向对象的思想 ,今天就试着把它封装了一下,弹出视图的内容可以根据自定义,此处只是用UIDatePicker来演示 我把它传到了GitHub上    ...

  7. layer关闭弹出层返回值到父页面

    1.首先在父页面定义一个空间,Id=layerResult 然后 layer.open({ type: , title: '选择看课件', shadeClose: true, shade: 0.8, ...

  8. OpenGL开发入门

    1.OpenGL简介: OpenGL ES (OpenGL for Embedded Systems) 是 OpenGL三维图形 API 的子集,针对手机.PDA和游戏主机等嵌入式设备而设计.该API ...

  9. 九、curator recipes之不可重入锁InterProcessSemaphoreMutex

    简介 recipes的InterProcessSemaphoreMutex是一种不可重入的互斥锁,也就意味着即使是同一个线程也无法在持有锁的情况下再次获得锁,所以需要注意,不可重入的锁很容易在一些情况 ...

  10. 01 使用JavaScript原生控制div属性

    写在前面: 因对前端开发感兴趣,于是自学前端技术,现在已经会HTML.CSS.JavaScript基础技术.但水平处于小白阶段,在网上找一些小项目练练手,促进自己的技术成长.文章记录自己的所思所想,以 ...